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4-9-09 MedWatch - The FDA Safety Information and Adverse Event Reporting Program
ZOLL Medical Corporation and FDA notified healthcare professionals of a Class 1 recall of ZOLL AED Plus Defibrillators distributed from May, 2004 through February 9, 2009. The recall was initiated because the device may fail to deliver a defibrillation shock, which could result in failure to resuscitate a patient during treatment of sudden cardiac arrest. On February 12 and March 31, 2009, the company sent their distributors and customers recall letters with recommendations and instructions for customers on specific steps to mitigate the identified problems with this device.
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4-14-09 MedWatch - The FDA Safety Information and Adverse Event Reporting Program
FDA notified healthcare professionals of an update to a previous alert that addresses the interaction of ceftriaxone with calcium-containing products, based on previously reported fatal cases in neonates. At the request of FDA, the manufacturer of ceftriaxone (Roche) conducted two in vitro studies to assess the potential for precipitation of ceftriaxone-calcium when ceftriaxone and calcium-containing products are mixed in vials and in infusion lines. These two in vitro studies were conducted in neonatal and adult plasma to assess the potential for precipitation of ceftriaxone-calcium using varying ceftriaxone and calcium concentrations, including concentrations in excess of those achieved in vivo. Based on the results from these studies, FDA now recommends that ceftriaxone and calcium-containing products may be used concomitantly in patients >28 days of age, using the precautionary recommendations noted because the risk of precipitation is low in this population. FDA had previously recommended, but no longer recommends, that in all age groups ceftriaxone and calcium-containing products should not be administered within 48 hours of one another.
4-15-09 MedWatch - The FDA Safety Information and Adverse Event Reporting Program
Teleflex Medical and FDA notified healthcare professionals of the Class 1 recall for Arrow International 30cc, 40cc and 50cc Intra Aortic Balloon Pump (IAB) Catheters, a component of the Intra-Aortic Pump System which is designed to provide cardiac assist therapy to critically ill people to increase blood flow to the heart. This recall is being conducted because a fault in the connector of the pump tubing assembly may result in failure of the system to decrease ischemia and increase perfusion, leading to organ injury or infarct and may result in patient death. Prolonged exposure could also result in thrombus formation on the IAB and possible subsequent systemic or cerebral thromboembolism.
4-16-09 MedWatch - The FDA Safety Information and Adverse Event Reporting Program
ION Labs and FDA notified consumers and healthcare professionals of the recall of all Influend Cough and Cold products sold on or after May 30, 2008 due to the possibility that the products may be superpotent with possible complications ranging from tachycardia, palpitations, arrhythmias, and cardiovascular collapse with hypotension to headaches, dizziness, anxiety, restlessness and nervousness. Customers who have this product in their possession should stop using it immediately and contact their physician if they have experienced any problems that may be related to taking this product.
4-22-09 MedWatch - The FDA Safety Information and Adverse Event Reporting Program
ABC Beauty Supply and FDA notified consumers and healthcare professionals of a recall of 34 dietary supplement products. FDA lab analyses identified undeclared sibutramine, an FDA-approved drug, used as an appetite suppressant for weight loss. FDA advises that these products pose a threat to consumers because sibutramine is known to substantially increase blood pressure and/or pulse rate in some patients and may present a significant risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias or stroke. See the firm's press release for a list of affected products.
4-29-09 MedWatch - The FDA Safety Information and Adverse Event Reporting Program
Personal Care Products and FDA notified healthcare professionals of a voluntarily nationwide recall of all lots of Personal Care non-acetone nail polish remover, conditioner enriched with gelatin, 6 fl. oz., UPC 4815592076, because it has the potential to cause chemical burns to the fingers of users.
Nature & Health Co. and FDA notified healthcare professionals of a recall of a supplement product, Libimax. FDA analysis found the product contains tadalafil, an active ingredient of an FDA-approved drug for erectile dysfunction. This product poses a threat to health because tadalafil may interact with nitrates found in some prescription drugs (such as nitroglycerin) and may lower blood pressure to dangerous levels. Consumers with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates. Consumers who have Libimax in their possession should stop using it immediately and contact their physician if they experienced any problem that may be related to taking this product.
4-30-09 MedWatch - The FDA Safety Information and Adverse Event Reporting Program
FDA notified healthcare professionals that after an ongoing safety review initiated in February 2008, the manufacturers of licensed botulinum toxin products will be required by FDA to strengthen warnings in product labeling and add a boxed warning regarding the risk of adverse events when the effects of the toxin spread beyond the site where it was injected. FDA will also require that manufacturers develop and implement a Risk Evaluation and Mitigation Strategy [REMS], including a communication plan to provide more information regarding the risk for distant spread of botulinum toxin effects after local injection, as well as information to explain that botulinum toxin products cannot be interchanged. The REMS would also include a Medication Guide that explains the risks to patients, their families, and caregivers. FDA is requiring the manufacturers to submit safety data after multiple administrations of the product in a specified number of children and adults with spasticity to assess the signal of serious risk regarding distant spread of toxin effects. FDA’s evaluation of the data continues to support the recommendations made in the 2008 Early Communication.
5-1-09 MedWatch - The FDA Safety Information and Adverse Event Reporting Program
Disetronic Medical Systems Inc. and FDA notified healthcare professionals about a defect in the “up” and/or “down” buttons of some ACCU-CHEK Spirit insulin pumps. This failure may present as an intermittent or complete loss of function of the “up” and/or “down” buttons. If the buttons do not function, users may not be able to change any programmed setting on the pump. If this failure occurs, the pump may not respond with a vibration or acoustic confirmation signal to a button press and the display will remain unchanged. Users may contact ACCU-CHEK Spirit hotline noted in the Press Release for a replacement pump or for any other questions regarding this potential defect.
FDA warned consumers to immediately stop using Hydroxycut products by Iovate Health Sciences, Inc. Hydroxycut products are associated with a number of serious liver injuries. Hydroxycut products are dietary supplements that are marketed for weight-loss, as fat burners, as energy-enhancers, as low carb diet aids, and for water loss under the Iovate and MuscleTech brand names.
FDA has received 23 reports of serious health problems ranging from jaundice and elevated liver enzymes, an indicator of potential liver injury, to liver damage requiring liver transplant. One death due to liver failure has been reported to FDA. Other health problems reported include seizures; cardiovascular disorders; and rhabdomyolysis, a type of muscle damage that can lead to other serious health problems such as kidney failure.
The agency has not yet determined which ingredients, dosages, or other health-related factors may be associated with risks related to these Hydroxycut products. The FDA continues to investigate the potential relationship between Hydroxycut dietary supplements and liver injury or other potentially serious side effects.
5-7-09 MedWatch - The FDA Safety Information and Adverse Event Reporting Program
FDA notified healthcare professionals that it will require two prescription topical testosterone gel products, AndroGel 1% and Testim 1%, to include a boxed warning on the products’ labels after receiving reports of adverse effects in children who were inadvertently exposed to testosterone through contact with another person being treated with these products. Despite the currently labeled precautions, FDA has received reports of eight cases of secondary exposure to testosterone in children ranging in age from nine months to five years. Since that time, additional reports of secondary exposure have been received by the agency and are presently under review. Of the fully reviewed cases, adverse events reported in these children included inappropriate enlargement of the genitalia (penis or clitoris), premature development of pubic hair, advanced bone age, increased libido and aggressive behavior. The gels are approved for use in men who either no longer produce testosterone or produce it in very low amounts. Both products are applied once daily, to the shoulders or upper arms. FDA has provided recommendations and precautions to minimize the potential for secondary exposure.
5-8-09 MedWatch - The FDA Safety Information and Adverse Event Reporting Program
Biosite and FDA notified healthcare professionals of the Class 1 recall of the Biosite brand Triage Cardiac Panel, a test is used by health professionals as an aid in the diagnosis of a heart attack (myocardial infarction).The use of the affected lot may lead to false negative results with patient samples containing troponin I at very low levels, with CK-MB, and with myoglobin, possibly resulting in missed or incorrect diagnosis. A false negative test result would indicate that a person has not had a heart attack or heart muscle injury when in fact they have. Lot #W44467B, shipped as 25 individually pouched devices per kit box, was distributed from January 24, 2009 through February 17, 2009. On April 27, 2009, the company sent an urgent recall notice to customers who were instructed to immediately discontinue all use of, and to discard, all affected products.
OSI, Genentech and FDA notified healthcare professionals of new safety information added to the WARNINGS AND PRECAUTIONS sections of the prescribing information for Tarceva. Gastrointestinal perforation (including fatalities), bullous, blistering and exfoliative skin conditions including cases suggestive of Stevens-Johnson syndrome/toxic epidermal necrolysis, in some cases fatal, and ocular disorders, including corneal perforation or ulceration have been reported during use of Tarceva. The new safety information comes from routine pharmacovigilance activities of clinical study and postmarketing reports. Tarceva monotherapy is indicated for the treatment of patients with locally advanced or metastatic non-small cell lung cancer after failure of at least one prior chemotherapy regimen. In combination with gemcitabine, Tarceva is also indicated for the first-line treatment of patients with locally advanced, unresectable, or metastatic pancreatic cancer.
5-12-09 MedWatch - The FDA Safety Information and Adverse Event Reporting Program
FDA is notifying consumers and healthcare professionals of the recall of cosmetic “Face Paint” items labeled as distributed by Oriental Trading Co., Omaha, Neb., due to adverse event reports of skin reactions in children, including rashes, itchiness, burning sensation, and swelling where the face paints were applied. All exposures occurred on the same day at an organized event in children exposed to various colors of the face paint. Significant microbial contamination was indicated in most of the products in testing by an FDA laboratory. These items were distributed nationwide.
AS Medication Solutions, LLC, a drug repackage company, announced today that all tablets of Caraco brand Digoxin, USP, 0.25 mg, distributed prior to March 31, 2009, which are not expired and are within the expiration date of August, 2011, are being voluntarily recalled to the consumer level. The tablets are being recalled because they may differ in size and therefore could have more or less of the active ingredient, digoxin. Caraco Pharmaceutical Laboratories, Ltd manufactured the recalled tablets. The recalled product is a scored round biconvex white tablet imprinted with “441”, with an NDC number of 54569-5758-0 (30-count). Consumers with the product that are within expiration should return these products to their pharmacy or place of purchase.
5-18-09 MedWatch - The FDA Safety Information and Adverse Event Reporting Program
Respironics and FDA notified healthcare professionals of a Class I recall of SmartMonitor 2 Infant Apnea Monitor, Models 4002 and 4003, used for the continuous monitoring of respiration and heart rate of infant patients in the home or in the hospital. The monitors may fail to sound an alarm during periods of temporary interruption of breathing or low heart rates. The affected products were manufactured from January 16, 2008 through November 13, 2008 and distributed from January 17, 2008 through December 31, 2008.
5-28-09 MedWatch - The FDA Safety Information and Adverse Event Reporting Program
Centocor Ortho Biotech and FDA reminded healthcare professionals of the risk of serious fungal infections associated with TNF-αlpha blockers, including Simponi [golimumab]. FDA has reported that histoplasmosis and other invasive fungal infections are not consistently recognized in patients taking other TNF-αlpha blockers including Cimzia (certolizumab pegol), Enbrel (etanercept), Humira (adalimumab), and Remicade (infliximab). This has resulted in delays in appropriate antifungal treatment, sometimes even resulting in death. It is important that all adverse events potentially associated with Simponi be reported so that the adverse event profile reported in the prescribing information can be updated appropriately as post-approval experience is gathered. Centocor encourages reporting adverse events to Centocor at 1-800-457-6399.
6-3-09 MedWatch - The FDA Safety Information and Adverse Event Reporting Program
FDA notified healthcare professionals of the risk of serious liver injury, including liver failure and death, with the use of propylthiouracil (PTU) in adult and pediatric patients. Reports to FDA’s Adverse Event Reporting System (AERS) suggest there is an increased risk of hepatotoxicity with PTU when compared to methimazole (MMI). FDA has identified 32 (AERS) cases (22 adult and 10 pediatric) of serious liver injury associated with PTU use. Although both PTU and MMI are indicated for the treatment of hyperthyroidism due to Graves’ disease, healthcare professionals should carefully consider which drug to initiate in a patient recently diagnosed with Graves’ disease. Physicians should closely monitor patients on PTU therapy for symptoms and signs of liver injury, especially during the first six months after initiation of therapy. PTU should not be used in pediatric patients unless the patient is allergic to or intolerant of MMI, and there are no other treatment options available.
6-9-09 MedWatch - The FDA Safety Information and Adverse Event Reporting Program
FDA notified consumers and healthcare professionals that Clarcon Biological Chemistry Laboratory is recalling some skin sanitizers and skin protectants because of high levels of disease-causing bacteria found in the product. During an FDA inspection, analyses of samples of several of these products revealed high levels of various bacteria, including some associated with unsanitary conditions. Some of these bacteria can cause opportunistic infections of the skin and underlying tissues. Such infections may need medical or surgical attention, and may result in permanent damage. These findings are particularly concerning because the products are promoted as antimicrobial agents that claim to treat open wounds, damaged skin, and protect against various infectious diseases. FDA is warning consumers to not use any Clarcon products and should throw these products away in household refuse.
6-11-09 MedWatch - The FDA Safety Information and Adverse Event Reporting Program
FDA notified healthcare professionals of clinical trial data that suggest increased mortality in stable liver transplant patients after conversion from a calcineurin inhibitor (CNI)-based immunosuppressive regimen to sirolimus (Rapamune). The trial was conducted by sirolimus manufacturer, Wyeth. The Agency will continue to examine the data on mortality and other adverse events in this study, and will make further recommendations, as appropriate. The FDA is determining whether a labeling change for sirolimus is needed. In the interim, physicians should continue to use the drug’s professional labeling as a guide to therapy.
Medtronic and FDA notified healthcare professionals and patients of a Class I recall of Medtronic Kappa Series 600/700/900 and Sigma Series 100/200/300 pacemakers due to a failure of the devices to pace the heart. Patients with malfunctioning pacemakers may experience a return of symptoms associated with abnormal heart rate, such as fainting or lightheadedness. In rare cases, pacemaker-dependent patients may experience serious injury or even death. These devices may fail due to a separation of wires that connect the electronic circuit to other pacemaker components, such as the battery. Most of the pacemakers affected by this recall have been implanted in patients for five years or longer. To determine if a pacemaker is part of this recall, contact Medtronic at 1-800-505-4636.
6-13-09 MedWatch - The FDA Safety Information and Adverse Event Reporting Program
FDA notified patients and healthcare professionals that some stolen vials of the long-acting insulin Levemir made by Novo Nordisk Inc. are being sold in the U.S. market, may not have been stored and handled properly, and may be dangerous for patients to use. The agency is advising patients who use Levemir insulin to:
6-15-09 MedWatch - The FDA Safety Information and Adverse Event Reporting Program
FDA notified healthcare professionals that it is providing its perspective on study data published in the American Journal of Psychiatry on the potential risks of stimulant medications used to treat Attention-Deficit/Hyperactivity Disorder (ADHD) in children. This study, funded by the FDA and the National Institute of Mental Health (NIMH), compared the use of stimulant medications in 564 healthy children from across the United States who died suddenly to the use of stimulant medications in 564 children who died as passengers in a motor vehicle accident.The study authors concluded that there may be an association between the use of stimulant medications and sudden death in healthy children. Given the limitations of this study’s methodology, the FDA is unable to conclude that these data affect the overall risk and benefit profile of stimulant medications used to treat ADHD in children. FDA believes that this study should not serve as a basis for parents to stop a child’s stimulant medication. Parents should discuss concerns about the use of these medicines with the prescribing healthcare professional. Any child who develops cardiovascular symptoms (such as chest pain, shortness of breath or fainting) during stimulant medication treatment should immediately be seen by a doctor.
FDA is continuing its review of the strengths and limitations of this and other epidemiological studies that evaluate the risks of stimulant medications used to treat ADHD in children. FDA and the Agency for Healthcare Research and Quality are sponsoring a large epidemiological study that will provide further information about the potential risks associated with stimulant medication use in children. The data collection for this study will be complete later in 2009.
6-16-09 MedWatch - The FDA Safety Information and Adverse Event Reporting Program
FDA notified consumers and healthcare professionals to discontinue use of three Zicam Nasal Gel/Nasal Swab products sold over-the-counter as cold remedies because they are associated with the loss of sense of smell that may be long-lasting or permanent. The FDA has received more than 130 reports of loss of sense of smell associated with the use of the three Zicam products. In these reports, many people who experienced a loss of smell said the condition occurred with the first dose; others reported a loss of the sense of smell after multiple uses of the products. People who have experienced a loss of sense of smell or other problems after use of the affected Zicam products should contact their health care professional. The loss of sense of smell can adversely affect a person’s quality of life, and can limit the ability to detect the smell of gas or smoke or other signs of danger in the environment.
6-17-09 MedWatch - The FDA Safety Information and Adverse Event Reporting Program
FDA notified healthcare professionals that it has finished its analysis of a possible risk of higher death with cefepime, an antibiotic, following publication of a study that suggested a higher rate of death in patients treated with this drug, as compared to patients treated with similar drugs. FDA reviewed this study data and conducted additional analyses based on additional data, including data submitted by Bristol Meyers Squibb. FDA has determined that the data do not indicate a higher rate of death in cefepime-treated patients. Cefepime remains an appropriate therapy for its approved indications. FDA will continue to review the safety of cefepime. As part of this ongoing review, both FDA and Bristol Meyers Squib are conducting separate analyses of death potentially associated with cefepime, using hospital drug use data. The results of these analyses likely will be reported in approximately one year.
6-19-09 MedWatch - The FDA Safety Information and Adverse Event Reporting Program
FDA and Hi-Tech Pharmaceuticals notified patients and healthcare professionals of a nationwide recall of all products sold under the name Stamina-Rx. FDA lab analysis found that the product contained the undeclared ingredient − benzamidenafil − a drug in the same therapeutic class of active pharmaceutical ingredients that include the PDE5 inhibitors sildenafil, tadalafil, and vardenafil, that are FDA-approved for the treatment of erectile dysfunction. Benzamidenafil is not FDA-approved, and poses a threat to consumers because benzamidenafil may interact with nitrates found in some prescription drugs (such as nitroglycerin) and may lower blood pressure to dangerous levels. Consumers with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates and may be most susceptible to adverse effects from this product. Stamina-Rx is sold predominantly in health food and drug stores nationwide. Consumers who have this product in their possession should stop using it immediately.
6-20-09 MedWatch - The FDA Safety Information and Adverse Event Reporting Program
FDA and the CDC are warning consumers not to eat any varieties of prepackaged Nestle Toll House refrigerated cookie dough due to the risk of contamination with E. coli O157:H7 (a bacterium that causes food borne illness). The warning is based on an ongoing epidemiological study conducted by the CDC and several state and local health departments. Since March 2009 there have been 66 reports of illness across 28 states. Twenty-five persons were hospitalized; 7 with a severe complication called Hemolytic Uremic Syndrome (HUS). No one has died.E. coli O157:H7 causes abdominal cramping, vomiting and a diarrheal illness, often with bloody stools. Most healthy adults can recover completely within a week. Young children and the elderly are at highest risk for developing HUS, which can lead to serious kidney damage and even death.
FDA advises that if consumers have any prepackaged, refrigerated Nestle Toll House cookie dough products in their home that they throw them away. Cooking the dough is not recommended because consumers might get the bacteria on their hands and on other cooking surfaces. Individuals who have recently eaten prepackaged, refrigerated Toll House cookie dough and have experienced any of these symptoms should contact their doctor or health care provider immediately. Any such illnesses should be reported to state or local health authorities.
7-01-09 MedWatch - The FDA Safety Information and Adverse Event Reporting Program
FDA notified healthcare professionals and patients that it is aware of four recently-published observational studies that looked at the use of Lantus (insulin glargine) and possible risk for cancer in patients with diabetes. Three of the four studies suggest an increased risk for cancer associated with use of Lantus. Based on the currently available data, the FDA recommends that patients should not stop taking their insulin therapy without consulting a physician, since uncontrolled blood sugar levels can have both immediate and long-term serious adverse effects.
FDA is currently reviewing many sources of safety data for Lantus, including these newly published observational studies, data from all completed controlled clinical trials, and information about ongoing controlled clinical trials, to better understand the risk, if any, for cancer associated with use of Lantus. Discussions are also ongoing between FDA and the manufacturer of Lantus as to whether any additional studies evaluating the safety and efficacy of this drug will need to be performed. FDA will communicate the results on its ongoing review to the public, as appropriate, as our review continues.
FDA notified healthcare professionals and patients that it has required the manufacturers of the smoking cessation aids varenicline (Chantix) and bupropion (Zyban and generics) to add new Boxed Warnings and develop patient Medication Guides highlighting the risk of serious neuropsychiatric symptoms in patients using these products.These symptoms include changes in behavior, hostility, agitation, depressed mood, suicidal thoughts and behavior, and attempted suicide.The added warnings are based on the continued review of postmarketing adverse event reports for varenicline and bupropion received by the FDA. These reports included those with a temporal relationship between the use of varenicline or bupropion and suicidal events and the occurrence of suicidal ideation and suicidal behavior in patients with no history of psychiatric disease. Healthcare professionals should advise patients to stop taking varenicline or bupropion and contact a healthcare provider immediately if they experience agitation, depressed mood, and any changes in behavior that are not typical of nicotine withdrawal, or if they experience suicidal thoughts or behavior.
7-07-09 MedWatch - The FDA Safety Information and Adverse Event Reporting Program
FDA informed healthcare professionals of instances in which pieces of tissue have remained within arthroscopic shavers, a device used in orthopedic surgical procedures, even after the cleaning process was believed to have been completed according to the manufacturer’s instructions. Since retained tissue in these devices can compromise the entire sterilization process, FDA is actively working with the manufacturers of these devices to gather more data about this situation and to understand its potential public health impact. FDA encourages facilities that use any of these types of devices to evaluate the adequacy of their cleaning procedures and has provided recommendations for minimizing the potential risk to patients.
FDA notified healthcare professionals that it is taking several actions to reduce the risk of overdose in patients using pain medications that contain propoxyphene because of data linking propoxyphene and fatal overdoses. The agency will require manufacturers of propoxyphene-containing products to strengthen the label, including the boxed warning, emphasizing the potential for overdose when using these products and to provide a medication guide to patients stressing the importance of using the drugs as directed.
FDA is requiring a new safety study assessing unanswered questions about the effects of propoxyphene on the heart at higher than recommended doses. Findings from this study, as well as other data, could lead to additional regulatory action. To further evaluate the safety of propoxyphene, FDA plans to work with several groups including the Centers for Medicare & Medicaid Services and the Veterans Health Administration to study how often the elderly are prescribed propoxyphene instead of other pain relievers and the difference in the safety profiles of propoxyphene compared to other drugs.
7-09-09 MedWatch - The FDA Safety Information and Adverse Event Reporting Program
Respironics California, Inc. and FDA notified healthcare professionals of a Class I recall of the BiPAP Focus Non-Invasive Ventilator System, model number PCM120PS18-2315P. Power supply failures have occurred on some ventilators. This product was distributed from August, 2006 through April 11, 2008. Customers/distributors may contact Respironics U.S. Customer Service at 1-877-387-3377 or Respironics International Customer Service at 1-724-387-4000.
Vital Pharmaceuticals Inc. and FDA notified healthcare professionals and consumers of a nationwide recall of the powdered dietary supplement, Stealth Chocolate and Stealth Vanilla, because it has the potential to be contaminated with Salmonella, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. The product was distributed nationwide, including GNC Distribution Centers, VPX Sports Distribution Center, and internationally. Healthy persons infected with Salmonella often experience fever, diarrhea (which may be bloody), nausea, vomiting and abdominal pain. Consumers should return the product to the store where it was purchased.
7-10-09 MedWatch - The FDA Safety Information and Adverse Event Reporting Program
Covidien and FDA announced the recall of one lot [#370-9004] of Mallinckrodt Sodium Chromate Cr-51 Injection as a result of routine post-market testing in which the product was found to be subpotent. Sodium Chromate Cr-51 Injection is a radiopharmaceutical agent used in a diagnostic test to determine the presence of a disease known as Polycythemia rubra vera. Using subpotent product could lead to an incorrect test result. A misdiagnosis or delayed diagnosis followed by a delay in treatment puts patients at an increased risk of embolus or stroke. This recall is being conducted to inform healthcare providers of the potential for a false low reading of red blood cell volume and to prevent further use of the product. Customers who have product from the recalled lot in their possession should discontinue use immediately. Customers with questions about the recalled product, including returns, should contact Product Monitoring at 800-778-7898 (7:00 am to 5:00 pm CT).
7-13-09 MedWatch - The FDA Safety Information and Adverse Event Reporting Program
Medtronic, Inc. and FDA notified healthcare professionals and patients of a recall of Quick-set infusion sets that are used with MiniMed Paradigm insulin pumps because the affected infusion sets may not allow the insulin pump to vent air pressure properly. This could potentially result in the device delivering too much or too little insulin and may lead to serious injury or death. An infusion set is a thin plastic tube used to deliver insulin from an insulin pump to a diabetes patient, and is typically replaced by the patient every three days. Affected infusion sets are reference numbers MMT-396, MMT-397, MMT-398 and MMT-399 with lot numbers starting with the number “8". Patients should discontinue using “Lot 8” Quick-set infusion sets. The lot number (for example 8XXXXXX) is clearly marked on both the product box label, and on each individual infusion set package. Customers are being asked to return any affected infusion sets to the company.
7-14-09 MedWatch - The FDA Safety Information and Adverse Event Reporting Program
The FDA is requiring the makers of certain immunosuppressant drugs to update their labeling to reflect that immunosuppressed patients are at increased risk for opportunistic infections, such as activation of latent viral infections, including BK virus-associated nephropathy. These immunosuppressant drugs are used to protect against the rejection of certain organ transplants. The association of BK virus-associated nephropathy has previously been reported for another immunosuppressant drug, tacrolimus (marketed as Prograf). Monitoring for this serious risk and early intervention by the health care provider is critical. Adjustments in immunosuppression therapy should be considered for patients who develop BK virus-associated nephropathy.
7-15-09 MedWatch - The FDA Safety Information and Adverse Event Reporting Program
Brookstone Pharmaceuticals and FDA notified healthcare professionals and consumers of a nationwide voluntary recall of all lots of Concentrated Acetaminophen Drops (NDC#42192-504-16) in 16 ounce (473 ml) bulk containers. The recalled drops were manufactured by Pharmaceutical Associates, Inc. This 16oz container is comparable to the size generally used to package regular strength acetaminophen liquid preparations. This aspect of the product coupled with the absence of an integrated dosage delivery device is a contributing factor to possible dosing errors, especially inadvertent overdosing. Over dosage of acetaminophen may result in liver toxicity, kidney damage, and blood disorders. The firm is recalling its product to the consumer level as a cautionary measure to minimize any confusion and potential risk to patients from dosing errors.
7-16-09 MedWatch - The FDA Safety Information and Adverse Event Reporting Program
Nature & Health Co., announced a voluntary nationwide recall of the company's supplement products sold under the following names: LibieXtreme, Y-4ever, Libimax X Liquid, Powermania Liquid and Capsule, Herbal Disiac. Lab analysis by FDA of these products found they contain either tadalafil, an active ingredient of an FDA-approved drug for erectile dysfunction (ED), its analog aminotadalafil, or the analog of sildenafil, an active ingredient of another FDA-approved ED drug, making these products unapproved drugs. The undeclared ingredients may interact with nitrates found in some prescription drugs such as nitroglycerin and may lower blood pressure to dangerous levels. Customers who have these products in their possession should stop using it immediately and contact their physician if they have experienced any problems that may be related to taking these products.
FDA is evaluating interim safety findings from an ongoing study of Xolair (omalizumab) titled Evaluating the Clinical Effectiveness and Long-Term Safety in Patients with Moderate to Severe Asthma (EXCELS) that suggests a disproportionate increase in ischemic heart disease, arrhythmias, cardiomyopathy and cardiac failure, pulmonary hypertension, cerebrovascular disorders, and embolic, thrombotic and thrombophlebitic events in patients treated with Xolair compared to the control group of patients not given the drug. Xolair is approved for use by adults and adolescents (12 years of age and above) with moderate to severe persistent asthma who test positive for reactivity to a perennial airborne allergen, and whose symptoms are inadequately controlled with inhaled corticosteroids.
FDA is not recommending any changes to the prescribing information for Xolair and is not advising patients to stop taking Xolair at this time. Until the evaluation of the EXCELS study is completed, healthcare providers and patients should be aware of the risks and benefits described in the prescribing information, as well as the new information from the ongoing EXCELS study that may suggest a risk of cardiovascular and cerebrovascular adverse events.
7-17-09 MedWatch - The FDA Safety Information and Adverse Event Reporting Program
Teva Pharmaceuticals and FDA notified healthcare professionals of a recall of Propofol Injectable Emulsion 10 mg/mL 100 mL vials, lot numbers 31305429B and 31305430B. The product lots identified are being recalled due to the presence of elevated endotoxin levels in some vials within these lot numbers. Teva has been notified of 41 propofol-treated patients who experienced post-operative fever, chills and other flu-like symptoms. Adverse health effects, such as fever, chills, or rigors, are possible with exposure to product with elevated levels of endotoxins. Serious adverse effects, such as disseminated intravascular coagulopathy, acute respiratory distress syndrome, shock, and death, are possible with exposure to product with high endotoxin levels.
Customers who have Propofol lots 31305429B and 31305430B in their possession are instructed to cease using the product and return it to their distributor.
Young You Corporation and FDA notified healthcare professionals and consumers that four weight loss dietary supplements sold and marketed by the firm (Slimbionic, One Weight Loss Pill, SlimDemand Capsules, Botanical Weight Loss) contain an undeclared drug ingredient, Sibutramine, an FDA-approved drug used as an appetite suppressant for weight loss. The FDA has not approved the products as drugs; therefore the safety and effectiveness of this product is unknown. FDA advises that these products pose a threat to consumers because sibutramine is known to substantially increase blood pressure and/or pulse rate in some patients and may present a significant risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias or stroke.
The products were sold and distributed nationwide via the internet and at the company’s Weight Loss and Rejuvenation Center in Tarzana, Ca.
7-18-09 MedWatch - The FDA Safety Information and Adverse Event Reporting Program
Luv N’ Care and FDA notified all consumers/parents and healthcare professionals of a nationwide recall of Nuby Gel Filled, Cottontails, and Playschool Teethers. The firm recalled the products after learning that samples of two lots collected by FDA were found to contain Bacillus subtilis and Bacillus circulans in the gel. These bacteria generally do not cause illness, but bacteria can affect children with weakened immune systems, causing stomach pain, vomiting, and diarrhea, if the teether is punctured and the liquid from the teether is ingested. Product was distributed through retail outlets nationwide and has been found to be marketed on the internet. The products are packaged in a plastic bubble on a printed card and can be identified by the UPC Codes listed. Consumers who have Nuby Gel Filled Teethers and Cottontails and Playschool Teethers with any of the UPC Codes listed should immediately stop using them, discard them or return them to the place of purchase.
7-22-09 MedWatch - The FDA Safety Information and Adverse Event Reporting Program
Draeger Medical and FDA notified healthcare professionals that it recommends the removal of Stabilet Infant Warmer models 200, 300, 1250, 1500, 200/3000, 2000, 2200/3200, 3000, and 3200 from service as soon as possible due to concern that continued use of these devices may result in serious injury to the patient and/or caregiver. A January 2008 fire in a Minnesota neonatal unit injured an infant and an independent investigation concluded that the Hill-Rom Stabilet 1250 was likely the ignition source of the fire. Draeger agrees with the recommendation to remove the referenced Stabilet models from service immediately. Immediate actions required include:
A recall notification is being sent out to all known current users and is available in the Draeger website at www.draeger.com/Stabilet.
FDA notified healthcare professionals and patients that a laboratory analysis of electronic cigarette samples has found that they contain carcinogens and toxic chemicals such as diethylene glycol, an ingredient used in antifreeze. Electronic cigarettes, also called “e-cigarettes,” are battery-operated devices that generally contain cartridges filled with nicotine, flavor and other chemicals. The electronic cigarette turns nicotine, which is highly addictive, and other chemicals into a vapor that is inhaled by the user. These products are marketed and sold to young people and are readily available online and in shopping malls. They are also available in different flavors, such as chocolate and mint, which may appeal to young people.
The FDA’s Division of Pharmaceutical Analysis analyzed the ingredients in a small sample of cartridges from two leading brands of electronic cigarettes. In one sample, the FDA’s analyses detected diethylene glycol, a chemical used in antifreeze that is toxic to humans, and in several other samples, the FDA analyses detected carcinogens, including nitrosamines. These products do not contain any health warnings comparable to FDA-approved nicotine replacement products or conventional cigarettes. Because these products have not been submitted to the FDA for evaluation or approval, at this time the agency has no way of knowing, except for the limited testing it has performed, the levels of nicotine or the amounts or kinds of other chemicals that the various brands of these products deliver to the user.
7-28-09 MedWatch - The FDA Safety Information and Adverse Event Reporting Program
FDA notified both healthcare professionals and their patients about new safety information concerning products marketed for body building and increasing muscle mass, frequently marketed as alternatives to anabolic steroids for increasing muscle mass and strength and sold both online and in retail stores. These products are promoted to athletes to improve sports performance and to aid in recovery from training and sporting events. Although marketed as dietary supplements, they are not dietary supplements, but instead are unapproved new drugs that have not been reviewed by the FDA for safety and effectiveness.
Adverse event reports received by the FDA for body building products that are labeled to contain steroids or steroid alternatives involve men and include cases of serious liver injury, stroke, kidney failure and pulmonary embolism (blockage of an artery in the lung). Due to the potentially serious health risks associated with using these types of products, the FDA recommends that consumers immediately stop using all body building products that claim to contain steroids or steroid-like substances. Health care professionals are advised to ask their patients about any over-the-counter products they may be using, including products marketed as dietary supplements.
7-29-09 MedWatch - The FDA Safety Information and Adverse Event Reporting Program
Nutracoastal Trading LLC and FDA notified healthcare professionals and consumers of a nationwide recall of the company's dietary supplement product sold under the name Steam. Lab analysis by FDA found that the product contains sulfoaildenafil, an analog of sildenafil. Sildenafil is an active ingredient of an FDA-approved drug for erectile dysfunction (ED), making Steam an unapproved drug. The undeclared ingredient may interact with nitrates found in some prescription drugs such as nitroglycerin and may lower blood pressure to dangerous levels. Additionally, the product may cause side effects, such as headaches and flushing. The recalled product was distributed in white plastic bottles to retail stores nationwide. Customers who have this product in their possession should stop using it immediately and contact their physician if they have experienced any problems that may be related to taking this product.
7-30-09 MedWatch - The FDA Safety Information and Adverse Event Reporting Program
FDA notified healthcare professionals of the approval of the first single-ingredient oral colchicine product, Colcrys, for the treatment of familial Mediterranean fever (FMF) and acute gout flares and of two previously uncharacterized safety concerns associated with the use of colchicine. Oral colchicine has been used for many years as an unapproved drug with no FDA-approved prescribing information, dosage recommendations, or drug interaction warnings.
FDA analyzed safety data for colchicine from adverse events reported to the Agency, the published literature, and company-sponsored pharmacokinetic and drug interaction studies. This analysis revealed cases of fatal colchicine toxicity reported in certain patients taking standard therapeutic doses of colchicine and concomitant medications that interact with colchicine, such as clarithromycin. These reports suggest that drug interactions affecting the gastrointestinal absorption and/or hepatic metabolism of colchicine play a central role in the development of colchicine toxicity. Data submitted supporting the safety and efficacy of Colcrys in acute gout flares demonstrated that a substantially lower dose of colchicine was as effective as the higher dose traditionally used. Moreover, patients receiving the lower dose experienced significantly fewer adverse events compared to the higher dose.
Based on this information, FDA has included important safety considerations in the approved prescribing information to assure safe use of Colcrys and is providing background information, a data summary and recommendations in this alert.
Abbott and FDA notified healthcare professionals of the national Class 1 recall of three lots of POWERSAIL Coronary Dilatation Catheters from United States distribution and one lot from international distribution as a result of four complaints that the distal shaft of the catheter exhibited damage. The damage may cause a leak of contrast material during use, which could lead to catheter functional failures and clinical consequences, including air embolism and myocardial infarction, which has the potential to lead to death.
Customers with questions or concerns should contact their Abbott Vascular Representative or call the company at 1-800-227-9902.
8-03-09 MedWatch - The FDA Safety Information and Adverse Event Reporting Program
[UPDATED 08/03/2009 from original 04/06/2009 alert] FDA notified healthcare professionals of changes to the established drug names for Botox/Botox Cosmetic, Dysport and Myobloc to reinforce individual potencies and prevent medication errors, and provided recommendations for healthcare professionals to consider, plus information for patients, family members, and caregivers.
8-04-09 MedWatch - The FDA Safety Information and Adverse Event Reporting Program
FDA notified healthcare professionals that it has completed its analysis of tumor necrosis factor (TNF) blockers and has concluded that there is an increased risk of lymphoma and other cancers associated with the use of these drugs in children and adolescents. This new safety information is now being added to the Boxed Warning for these products. FDA has also identified new safety information related to the occurrence of leukemia and new-onset psoriasis in patients treated with TNF blockers. The current prescribing information for TNF blockers does contain a warning for malignancies, but does not specifically mention leukemia. FDA is also requiring updates to the current Medication Guide to help patients understand the risks associated with TNF blocker therapy. TNF blockers are approved for the treatment of one or more of a number of immune system diseases including juvenile idiopathic arthritis (JIA), rheumatoid arthritis, psoriatic arthritis, plaque psoriasis, Crohn’s disease, and ankylosing spondylitis.
8-26-09 MedWatch - The FDA Safety Information and Adverse Event Reporting Program
[UPDATED 08/26/2009] FDA is reminding the public that stolen vials of the long-acting insulin Levemir made by Novo Nordisk Inc. still may be on the market. Evidence gathered to date suggests that the stolen insulin was not stored and handled properly and may be dangerous for people to use. FDA has received multiple reports of patients who suffered an adverse event due to poor control of glucose levels after using a vial from one of the stolen lots.
8-27-09 MedWatch - The FDA Safety Information and Adverse Event Reporting Program
Tibotec Therapeutics and FDA notified healthcare professionals of revisions to the WARNINGS AND PRECAUTIONS section of the prescribing information for Intelence (etravirine). There have been postmarketing reports of cases of Stevens-Johnson syndrome, toxic epidermal necrolysis and erythema multiforme, as well as hypersensitivity reactions characterized by rash, constitutional findings, and sometimes organ dysfunction, including hepatic failure. Intelence therapy should be immediately discontinued when signs and symptoms of severe skin or hypersensitivity reactions develop.
9-03-09 MedWatch - The FDA Safety Information and Adverse Event Reporting Program
GlaxoSmithKline and FDA notified healthcare professionals that cases of Pure Red Cell Aplasia (PRCA) have been reported in patients treated with Myfortic. The WARNINGS and ADVERSE REACTIONS sections of the CellCept Prescribing Information have been revised to reflect this new safety information.
PRCA is a type of anemia in which there is a selective reduction of red blood cell precursors on bone marrow examination. Patients with PRCA may present with fatigue, lethargy, and/or abnormal paleness of the skin (pallor). In some cases, PRCA was found to be reversible with dose reduction or cessation of Myfortic therapy. In transplant patients, however, reduced immunosuppression may place the graft at risk.
9-04-09 MedWatch - The FDA Safety Information and Adverse Event Reporting Program
Novartis and FDA notified healthcare professionals that cases of Pure Red Cell Aplasia (PRCA) have been reported in patients treated with Myfortic. The WARNINGS and ADVERSE REACTIONS sections of the Myfortic Prescribing Information have been revised to reflect this new safety information.
FDA issued a Dear Healthcare Provider Letter to notify healthcare professionals and facilities of a number of complaints of inaccurate readings when using the Philips Avalon Fetal Monitors, Models FM20, FM30, FM40, and FM50 with the ultrasound transducer. On September 4, 2009, Philips issued an Important Device Safety Alert. Inaccurate output readings, if not properly addressed, may lead to unnecessary interventions, failure to identify the need for interventions, and failure to identify fetal distress. The complaints most commonly occur during the second stage of labor. Recognizing these conditions and responding appropriately is important to avoiding serious adverse health consequences.
The Philips alert describes the most common complaints reported, steps for the user to minimize the risk, and urges the user to review the Instructions for Use for Philips Avalon Fetal Monitors.
9-09-09 MedWatch - The FDA Safety Information and Adverse Event Reporting Program
Penumbra and FDA notified healthcare professionals of the Class 1 recall of the Neuron 5F Select Catheter, used to remove blood clots or foreign objects from blood vessels. Due to a manufacturing error, the catheters may contain pin holes and exposed wire braids which may result in a brain clot or a blood vessel puncture, and this may lead to possible death. The device was distributed from May 5, 2009 through June 12, 2009.
9-10-09 MedWatch - The FDA Safety Information and Adverse Event Reporting Program
FDA notified healthcare professionals of the Class 1 recall of two ConMed Linvatec surgical service products due to reports of a switch problem resulting in unintended self-activation of these powered tools, continued running after trigger release and tool movement in unintended directions. The products are:
The handpieces were distributed from March 29, 2002 through June 24, 2009. The cables were distributed from January 24, 2001 through February 27, 2009. ConMed has instructed users to stop using the cable immediately if the handpiece self-activates or an intermittent operation occurs and to return the handpiece and cable to the company for evaluation.
FDA notified healthcare professionals of a Class I recall of Pedi-Cap End-Tidal CO2 Detector (Pedi-Cap and Pedi-Cap 6), because the device may increase the resistance of the flow of air into the lungs, resulting in ineffective ventilation and the inability to verify the correct placement of a breathing tube when inserting it into the windpipe. This device is used in pediatric patients, weighing 2.2-33 pounds, during the process of exchanging oxygen for carbon dioxide (ventilation) in healthcare settings. There is a reasonable probability that use of the recalled PediCap will cause serious adverse health consequences or death. Covidien informed their distributors and customers to stop selling/using the affected devices and to return them to the company.
9-12-09 MedWatch - The FDA Safety Information and Adverse Event Reporting Program
Smiths Medical and FDA notified healthcare professionals about a nationwide voluntary recall of Portex Uncuffed Pediatric-Sized Tracheal Tubes (sizes 2.5, 3.0 and 3.5 mm). A small number of tubes were manufactured with internal diameters slightly smaller than indicated on the labeling, which may create the potential for the clinician to experience difficulty passing through or withdrawing the suction catheter. The health consequences that may result from use of the defective device include the inability to remove secretions from the device and from the patient's airway, which may result in partial or complete obstruction of the airway and an inability to ventilate the patient. In addition, this defect may increase airway resistance and compromise the ability to ventilate the patient. There is a reasonable probability of serious injury and/or death.
9-16-09 MedWatch - The FDA Safety Information and Adverse Event Reporting Program
FDA notified healthcare professionals of a Class I recall of certain LIFEPAK CR Plus Automated External Defibrillators (AED) manufactured and distributed from July 9, 2008 through August 19, 2008. An extremely humid environment may cause the affected devices to improperly analyze the heart rhythm and may cause the device to delay or fail to deliver therapy.
FDA notified healthcare professionals that a Boxed Warning is being added to the prescribing information for Promethazine Hydrochloride products, describing the risks of severe tissue injury, including gangrene, requiring amputation following intravenous administration of promethazine. The Boxed Warning will remind practitioners that due to the risks of intravenous injection, the preferred route of administration is deep intramuscular injection and that subcutaneous injection is contraindicated.
Perivascular extravasation, unintentional intra-arterial injection and intraneuronal or perineuronal infiltration of the drug may result in irritation and tissue damage. Healthcare professionals should be alert for signs and symptoms of potential tissue injury including burning or pain at the site of injection, phlebitis, swelling, and blistering.
9-22-09 MedWatch - The FDA Safety Information and Adverse Event Reporting Program
[Posted 09/17/2009] FDA continues to receive reports of progressive multifocal leukoencephalopathy (PML) in patients receiving Tysabri. Tysabri was approved by the FDA for the treatment of relapsing forms of multiple sclerosis (MS) in November 2004 and for moderately to severely active Crohn’s disease in January 2008. From July 2006, (when Tysabri marketing resumed) to September 8, 2009, 13 reported cases of Tysabri-related PML were confirmed worldwide in patients being treated for MS with Tysabri monotherapy. There have been no postmarketing reports of PML in patients treated with Tysabri for Crohn’s disease. Less than 2% of Tysabri use in the U.S. has been in patients with Crohn's disease. Based on available data from the U.S. and outside of the U.S., the current rate of PML in patients who have received at least 24 infusions ranges from 0.4 to 1.3 per 1,000 patients.
The risk for developing PML appears to increase with the number of Tysabri infusions received. At this time, the FDA is not requiring changes regarding PML to the Tysabri prescribing information or to the Tysabri risk management plan, called the TOUCH Prescribing Program.
9-24-09 MedWatch - The FDA Safety Information and Adverse Event Reporting Program
FDA issued a Public Health Alert to notify prescribers and pharmacists about potential dosing errors with Tamiflu (oseltamivir) for Oral Suspension. U.S. health care providers usually write prescriptions for liquid medicines in milliliters (mL) or teaspoons, while Tamiflu is dosed in milligrams (mg). The dosing dispenser packaged with Tamiflu has markings only in 30, 45 and 60 mg. The Agency has received reports of errors where dosing instructions for the patient do not match the dosing dispenser. Health care providers should write doses in mg if the dosing dispenser with the drug is in mg. Pharmacists should ensure that the units of measure on the prescription instructions match the dosing device provided with the drug.
FDA notified healthcare professionals of the Class 1 recall of Medtronic SC Catheters and Revision Kit Models: 8709SC, 8731SC, 8578, and 8596SC when paired with the Medtronic IsoMed Pump Model 8472, due to a design incompatibility resulting in a physical interference between the SC catheter connector and the IsoMed pump. This may prevent the SC catheter from completely connecting to the IsoMed pump, even though it may appear to be connected and feel secure and may lead to disruptions of therapy and revision surgery, which pose a risk of serious injury or death.
SC catheters are not compatible with IsoMed pumps but are compatible with Medtronic SynchroMed II and SynchroMed EL pumps. To date, Medtronic has received ten reports worldwide related to improper connection of an SC catheter to an IsoMed pump. In all ten reports, medical intervention was required to correct the condition. Medtronic has provided recommendations in their Medical Device Correction Letter (see link in FDA Recall Notice).
9-25-09 MedWatch - The FDA Safety Information and Adverse Event Reporting Program
FDA notified healthcare professionals and patients of revisions to the prescribing information for Januvia (sitagliptin) and Janumet (sitagliptin/metformin) to include information on reported cases of acute pancreatitis in patients using these products. Eighty-eight post-marketing cases of acute pancreatitis, including two cases of hemorrhagic or necrotizing pancreatitis in patients using sitagliptin, were reported to the Agency between October 2006 and February 2009. It is recommended that healthcare professionals monitor patients carefully for the development of pancreatitis after initiation or dose increases of sitagliptin or sitagliptin/metformin. Sitagliptin has not been studied in patients with a history of pancreatitis. Therefore, it is not known whether these patients are at an increased risk for developing pancreatitis and the medication should be used with caution and with appropriate monitoring in patients with a history of pancreatitis. Considerations for healthcare professionals, information for patients, and a Data Summary are provided.
10-07-09 MedWatch - The FDA Safety Information and Adverse Event Reporting Program
Unomedical and FDA notified healthcare professionals about the recall of the single-patient use Manual Pulmonary Resuscitator because of a malfunction which may impair the ability of the device to generate the positive pressure necessary to function properly and could potentially cause serious adverse health consequences or death. The recalled resuscitators were manufactured from July 2002 – March 2008 and the company set up a web page, http://www.unomedical.com/?pageid=H3160 with a list of affected lot numbers, guidance (diagram and photos) to allow customers to identify products subject to the recall in the event that the customer has already removed the primary product packaging, and instructions on what actions to take.
10-09-09 MedWatch - The FDA Safety Information and Adverse Event Reporting Program
[Posted 10/09/2009] FDA notified healthcare professionals that it has become aware of radiation overexposures during perfusion CT imaging performed to aid in the diagnosis of stroke at a particular facility, the patients receiving radiation doses that were approximately eight times the expected level. While this event involved a single kind of diagnostic test at one facility, the magnitude of these overdoses and their impact on the affected patients were significant. This situation may reflect more widespread problems with CT quality assurance programs and may not be isolated to this particular facility or this imaging procedure (CT brain perfusion). If patient doses are higher than the expected level, but not high enough to produce obvious signs of radiation injury, the problem may go undetected and unreported, putting patients at increased risk for long-term radiation effects.
FDA encourages every facility performing CT imaging to review its CT protocols and be aware of the dose indices normally displayed on the control panel. These indices include the volume computed tomography dose index and the dose-length product. For each protocol selected, and before scanning the patient, carefully monitor the dose indices displayed on the control panel. To prevent accidental overexposure, make sure that the values displayed reasonably correspond to the doses normally associated with the protocol. Confirm this again after the patient has been scanned. Patients should follow their doctor’s recommendations for receiving CT scans. While unnecessary radiation exposure should be avoided, a medically-needed CT scan has benefits that outweigh the radiation risks.
[Posted 10/09/2009] GlaxoSmithKline (GSK) and FDA notified healthcare professionals of a report of the death of a patient with influenza who received Relenza (zanamivir) Inhalation Powder which was solubilized and administered by mechanical ventilation. Relenza (zanamivir) Inhalation Powder is not intended to be reconstituted in any liquid formulation and is not recommended for use in any nebulizer or mechanical ventilator.
GSK is aware that Relenza Inhalation Powder is being removed from its FDA-approved packaging and dissolved in various solutions for the purpose of nebulizing zanamivir for inhalation by patients with influenza who are unable to take oral medications or unable to inhale Relenza Inhalation Powder using the Diskhaler. Relenza or zanamivir for nebulization have not been approved by the FDA. The safety, effectiveness, and stability of zanamivir use by nebulization have not been established.
Relenza Inhalation Powder should only be used as directed in the prescribing information by using the Diskhaler device provided with the drug product. Relenza Inhalation Powder is a mixture of zanamivir active drug substance and lactose drug carrier. This formulation is not designed or intended to be administered by nebulization. There is a risk that the lactose sugar in this formulation can obstruct proper functioning of mechanical ventilator equipment.
10-16-09 MedWatch - The FDA Safety Information and Adverse Event Reporting Program
American Regent and FDA notified healthcare professionals that anaphylactic-type reactions, including fatalities, have followed the parenteral administration of iron dextran injection. The Boxed Warning has been modified to recommend administering a test dose prior to the first therapeutic dose and observing for signs or symptoms of anaphylactic-type reactions during administration of Dexferrum. Fatal reactions have followed the test dose of iron dextran injection, even in situations where the test dose was tolerated. Patients with a history of drug allergy or multiple drug allergies may be at increased risk of anaphylactic-type reactions. It is recommended that resuscitation equipment and personnel trained in the detection and treatment of anaphylactic-type reactions be readily available during Dexferrum administration.
10-19-09 MedWatch - The FDA Safety Information and Adverse Event Reporting Program
[Posted 10/19/2009] FDA is investigating whether certain types of power cords used with medical devices may be defective. Two medical device manufacturers (Hospira, Inc. and Abbott Nutrition) have sent FDA 122 reports of sparking, charring, and fires from the power cords used with their devices. The companies' investigations of these reports determined that the power cord's prongs may crack and fail at/or inside the plug. The potential risks from this power cord failure include electrical shock, delay in setup and therapy, interruption of therapy, device failure, and fires. Depending on the device and therapy, these failures may potentially lead to serious adverse health consequences, including death.
All the reports received so far from Hospira and Abbott have involved AC power cords with a black plastic bridge manufactured by the Electri-cord Manufacturing Company. FDA is aware that Electri-cord has supplied the affected power cords to other medical device manufacturers. The agency is now attempting to determine which devices may be equipped with these cords.
FDA recommends that all users of medical devices, either in healthcare facilities or in the home, closely monitor the wear and tear on the electric cords used to power these devices. This vigilance is especially important in oxygen rich environments, in which electrical sparking and arcing may trigger a fire.
10-21-09 MedWatch - The FDA Safety Information and Adverse Event Reporting Program
American Regent and FDA notified healthcare professionals of a voluntary recall of all lots of Ketorolac Tromethamine Injection, USP 30 mg/mL, including NDC# 0517-0801-25 [30 mg/mL 1mL Single Dose Vial] and NDC# 0517-0902-25 [30 mg/mL 2mL Single Dose Vial (60 mg/2mL)]. There is a potential for particulate matter in conjunction with crystallization that may be present in the product, which may result in adverse events such as obstruction of blood vessels which can induce pulmonary emboli or thrombosis, activate platelets and/or neutrophils to induce anaphylactic reactions. Other adverse effects associated with the injection of particulate matter include foreign body granulomas, and local irritation at the injection site.
This recall does not include other concentrations of American Regent Ketorolac Tromethamine Injection. The product was distributed to wholesalers and distributors nationwide. Hospitals, surgi-centers, clinics and other healthcare facilities should not use any American Regent Ketorolac Tromethamine Injection, USP Injection 30 mg/mL for patient care and should immediately quarantine any product for return.
10-23-09 MedWatch - The FDA Safety Information and Adverse Event Reporting Program
Genentech and FDA notified healthcare professionals about a third case of progressive multifocal leukoencephalopathy [PML], the first case of PML in a patient with rheumatoid arthritis [RA] treated with Rituxan who has not previously received treatment with a TNF antagonist. Information to date suggests that patients with RA who receive Rituxan have an increased risk of PML.
Physicians should consider PML in any patient being treated with Rituxan who presents with new onset neurologic manifestations. Consultation with a neurologist, brain MRI, and lumbar puncture should be considered as clinically indicated.
10-25-09 MedWatch - The FDA Safety Information and Adverse Event Reporting Program
FDA notified healthcare professionals that, in response to a request from the U.S. Centers for Disease Control and Prevention, it has issued an emergency use authorization (EUA) for the investigational antiviral drug peramivir intravenous in certain adult and pediatric patients with confirmed or suspected 2009 H1N1 influenza infection who are admitted to a hospital. IV peramivir is authorized only for hospitalized adult and pediatric patients for whom therapy with an IV drug is clinically appropriate, based on one or more of the following: 1] the patient is not responding to either oral or inhaled antiviral therapy, 2] when drug delivery by a route other than an intravenous route is not expected to be dependable or feasible, or 3] for adults only, when the clinician judges IV therapy is appropriate due to other circumstances.
Given there are limited safety data on peramivir, mandatory reporting requirements are important to defining the safety profile of this unapproved drug. As part of the conditions of the EUA, health care providers (or designee) must report adverse events and all medication errors associated with peramivir to FDA’s MedWatch program within 7 calendar days from the onset of the adverse event. Additionally, healthcare providers (or designee) must conduct follow-up requested by FDA or CDC related to peramivir adverse event or medication error reports submitted to FDA.
10-27-09 MedWatch - The FDA Safety Information and Adverse Event Reporting Program
Qualitest Pharmaceuticals and FDA notified healthcare professionals of a nationwide recall of Accusure Insulin Syringes. All syringes, regardless of lot number, are subject to this recall. These syringes were distributed between January 2002 and October 2009 to wholesale and retail pharmacies nationwide (including Puerto Rico). The syringes in these lots may have needles which detach from the syringe. If the needle becomes detached from the syringe during use, it can become stuck in the insulin vial, push back into to the syringe, or remain in the skin after injection. Consumers who have any Accusure insulin syringes should stop using them and contact Qualitest at 1-800-444-4011 for reimbursement.
10-30-09 MedWatch - The FDA Safety Information and Adverse Event Reporting Program
Cordis and FDA notified healthcare professionals of a nationwide recall of all lots of the CROSSOVER Sheath Introducer, a long-coil reinforced,kink-resistant catheter sheath intended for use in arterial and venous procedures requiring the percutaneous introduction of therapeutic or diagnostic intravascular devices or fluids.
The recall was due to stretching or fracture of the sheath during use. In the event of a device fracture, separated segments of the device can embolize downstream in the bloodstream and impede blood flow distal to the point where it lodges, resulting in ischemia or infarct to the distal extremity. Since this device is coil reinforced, any separation of the cannula has the potential to expose portions of the coil creating the potential for vessel dissection or perforation. Unplanned open surgery may be required to remove the retained segments or control bleeding.
Pointe Scientific and FDA notified healthcare professionals of a nationwide recall of all size kits of Liquid Glucose Hexokinase Reagent catalog number G7517. The reagents have been found to fail linearity at >200mg/dL that results in inaccurate glucose values above this range. Distributors and testing laboratories who have received the Liquid Glucose Hexokinase Reagent (G7517) which is being recalled should destroy remaining inventory.
Testing laboratories should consider all test results obtained with the lot numbers listed above to be questionable. The laboratory should inform the patient’s attending physician, and determine, with their input, whether confirmation of the previous test results will be required.
11-02-09 MedWatch - The FDA Safety Information and Adverse Event Reporting Program
FDA notified healthcare professionals of revisions to the prescribing information for Byetta (exenatide) to include information on post-marketing reports of altered kidney function, including acute renal failure and insufficiency. Byetta, an incretin-mimetic, is approved as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
From April 2005 through October 2008, FDA received 78 cases of altered kidney function (62 cases of acute renal failure and 16 cases of renal insufficiency), in patients using Byetta. Some cases occurred in patients with pre-existing kidney disease or in patients with one or more risk factors for developing kidney problems. Labeling changes include:
11-03-09 MedWatch - The FDA Safety Information and Adverse Event Reporting Program
Bodybuilding.com and FDA notified healthcare professionals and patients of a nationwide and international recall of all lots and expiration dates of 65 dietary supplement products that were sold through the Company's website, www.bodybuilding.com.
FDA believes that the recalled products contain the following ingredients that are currently classified, or the FDA believes should be classified, as steroids: "Superdrol," "Madol," "Tren," "Androstenedione," and/or "Turinabol." Acute liver injury is known to be a possible harmful effect of using steroid-containing products. In addition, steroids may cause other serious long-term adverse health consequences in men, women, and children. These include shrinkage of the testes and male infertility, masculinization of women, breast enlargement in males, short stature in children, a higher predilection to misuse other drugs and alcohol, adverse effects on blood lipid levels, and increased risk of heart attack, stroke, and death.
11-09-09 MedWatch - The FDA Safety Information and Adverse Event Reporting Program
Hospira, Inc.and FDA notified healthcare professionals of the recall of 85 lots of Liposyn II 10%, Liposyn II 20%, Liposyn III 10%, Liposyn III 20%, and Liposyn III 30%, and 73 lots of Propofol Injectable Emulsion 1% products that begin with the lot numbers 79 and 80 because some of the containers may contain particulate matter. The source of the particulate matter has been identified as stainless steel equipment used in the manufacturing process. The affected lots were distributed between July 2009 and October 2009, and no other lots are affected by this recall. Since these particulate contaminants do not dissolve in blood they could potentially act as emboli and impede blood flow. Particulates may also cause mechanical damage to the body and may escalate damage through the Systemic Inflammatory Response Syndrome. Restriction in blood supply to tissues could lead to stroke, respiratory failure, kidney failure, liver failure, heart attack and/or death.
FDA and Edwards Lifesciences notified healthcare professionals about the Class 1 recall of CardioVations EndoClamp Aortic Catheter, Model Numbers EC1001 and EC65, a device that blocks off the aorta, monitors aortic pressure, and delivers solution to stop the heart during cardiopulmonary bypass procedures. The recall was initiated because the balloon catheters may spontaneously rupture during surgery. This product was manufactured from August, 2008 through August, 2009 and distributed from November, 2008 through September, 2009.
11-10-09 MedWatch - The FDA Safety Information and Adverse Event Reporting Program
[Posted 11/10/2009] FDA notified healthcare professionals that it is investigating energy levels in external biphasic defibrillators with shocks ≤ 200 J. FDA received reports of 14 events since 2006 in which a 200 J biphasic defibrillator was ineffective in providing defibrillation/cardioversion therapy to a patient, whereas a subsequent shock from a different 360 J biphasic defibrillator resulted in immediate defibrillation/cardioversion. The majority of events occurred during attempts at cardioversion of atrial fibrillation, but there was at least one instance with defibrillation of a ventricular arrhythmia as well. Analysis of the 14 cases does not suggest the need for any change to current clinical practice, and as FDA continues its evaluation of this situation, providers are encouraged to follow the American Heart Association’s guidelines/algorithms for treatment of cardiac arrhythmias, and to follow manufacturers’ instructions for using defibrillators.
11-12-09 MedWatch - The FDA Safety Information and Adverse Event Reporting Program
[Posted 11/12/2009] FDA notified healthcare professionals of a Class I Recall of all lots of the Synthes USA, Ti Synex II Vertebral Body Replacement, a device used in the T1-L5 portion of the spine to replace a collapsed, damaged, or unstable vertebral body. Reports of moderate to severe loss of vertebral body replacement height (caused by failure of the central body component) in situ at six to fifteen months post implantation were received. Potential adverse health issues that could be associated with this issue include neural injury, increased pain, spinal kyphosis if unrecognized, failure of supplementary fixation, and/or need for reoperation/revision surgery. Surgeons and hospitals in possession of the subject devices must stop implanting them immediately. This product was manufactured from June 8, 2007 through September 9, 2009 and distributed from July 2, 2007 through September 8, 2009.
11-13-09 MedWatch - The FDA Safety Information and Adverse Event Reporting Program
FDA and Genzyme notified healthcare professionals about the potential for foreign particle contamination of several products that are used to treat rare, serious, and life-threatening diseases. The foreign particles include stainless steel fragments, non-latex rubber from the vial stopper, and fiber-like material from the manufacturing process and could potentially cause serious adverse events in patients. Cerezyme, Fabrazyme, Myozyme, and Thyrogen are supplied as lyophilized powders requiring reconstitution before administration; Aldurazyme is supplied as a liquid solution.
Potential adverse events from IM administration of a contaminated product could include local pain, swelling and inflammation. Potential adverse reactions from IV administration of a product contaminated with foreign particles could be more serious, including damage to blood vessels or embolic events, and anaphylactic, allergic and immune-mediated reactions. It is also possible that the foreign particles could affect how well these products work.
The Agency is acutely aware of the critical need for patients to have continued access to these important products. In reaching its decision to allow these products to continue to be marketed, FDA has carefully considered the potential for serious adverse events, the likelihood that the recommendations in this notice will significantly reduce the risk of administration of contaminated products, and the lack of FDA-approved therapeutic alternatives for these products. The FDA is actively investigating the nature of the contamination and seeking immediate implementation of corrective actions to mitigate the situation.
FDA notified healthcare professionals of 35 reports of chondrolysis (necrosis and destruction of cartilage) in patients given continuous intra-articular infusions of local anesthetics with elastomeric infusion devices to control post-surgical pain. The local anesthetics (with and without epinephrine) were infused for extended periods of time (48 to 72 hours) directly into the intra-articular space using an elastomeric pump. Joint pain, stiffness, and loss of motion were reported as early as the second month after receiving the infusion. In more than half of these reports, the patients required additional surgery, including arthroscopy or arthroplasty (joint replacement).
Local anesthetics are approved as injections for the production of local or regional anesthesia or analgesia. The approved drug labels for local anesthetics do not include an indication for continuous intra-articular postoperative infusions or use of infusion devices, such as elastomeric pumps. The FDA has not cleared any infusion devices with an indication for use in intra-articular infusion of local anesthetics. Health care professionals are encouraged to follow the instructions for use of elastomeric infusion devices, and to not use these devices for continuous intra-articular infusion of local anesthetics after orthopedic surgery.
This notice provides further management considerations for healthcare professionals, information for patients, a data summary of the 35 reports, and references.
GMP Herbal Products and FDA notified consumers and healthcare professionals of a recall of Pai You Guo, a weight loss dietary supplement, due to the presence of undeclared drug ingredients. FDA lab analyses of dietary supplements were found to contain undeclared sibutramine, an FDA-approved drug used as an appetite suppressant for weight loss; and phenolphthalein, a solution used in chemical experiments and a suspected cancer-causing agent that is not approved for marketing in the United States. The FDA has not approved the Pai You Guo products as a drug; therefore the safety and effectiveness of this product is unknown. The product is sold either in a box of 30 capsules or a bag of 10 g powder. The affected products were sold and distributed nationwide via the internet.
FDA advises that these products pose a threat to consumers because sibutramine is known to substantially increase blood pressure and/or pulse rate in some patients and may present a significant risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias or stroke.
Consumers are advised to destroy the affected products or return them to the company’s address in Westminster, CA.
11-16-09 MedWatch - The FDA Safety Information and Adverse Event Reporting Program
[Posted 11/16/2009] FDA notified healthcare professionals of a Preliminary Public Health Notification describing deaths and serious complications associated with the use of Negative Pressure Wound Therapy (NPWT) systems. FDA has received reports of six deaths and 77 injuries associated with NPWT systems over the past two years.
NPWT systems are generally indicated for the management of wounds, burns, ulcers, flaps and grafts. They apply negative pressure to the wound in order to remove fluids, including wound exudates, irrigation fluids, and infectious materials. Healthcare professionals were advised to select patients for NPWT carefully, after reviewing the most recent device labeling and instructions. Patients should be monitored frequently in an appropriate care setting by a trained practitioner, and practitioners should be vigilant for potentially life-threatening complications, such as bleeding, and be prepared to take prompt action if they occur.
11-17-09 MedWatch - The FDA Safety Information and Adverse Event Reporting Program
[Posted 11/17/2009] FDA notified healthcare professionals of new safety information concerning an interaction between clopidogrel (Plavix), an anti-clotting medication, and omeprazole (Prilosec/Prilosec OTC), a proton pump inhibitor (PPI) used to reduce stomach acid. New data show that when clopidogrel and omeprazole are taken together, the effectiveness of clopidogrel is reduced. Patients at risk for heart attacks or strokes who use clopidogrel to prevent blood clots will not get the full effect of this medicine if they are also taking omeprazole. Separating the dose of clopidogrel and omeprazole in time will not reduce this drug interaction.
Other drugs that are expected to have a similar effect and should be avoided in combination with clopidogrel include: cimetidine, fluconazole, ketoconazole, voriconazole, etravirine, felbamate, fluoxetine, fluvoxamine, and ticlopidine.
[Posted 11/17/2009] IDS Sports and FDA notified consumers that five of the IDS's dietary supplement products (Bromodrol, Dual Action Grow Tabs, Grow Tabs, Mass Tabs, and Ripped Tabs TR) contain the following undeclared substances, which FDA considers to be steroids: “Madol,” “Turinabol,” “Superdrol,” and/or “Androstenedione.”
Acute liver injury is known to be a possible harmful effect of using steroid-containing products. In addition, steroids may cause other serious long-term adverse health consequences in men, women, and children. These include shrinkage of the testes and male infertility, masculinization of women, breast enlargement in males, short stature in children, a higher predilection to misuse other drugs and alcohol, adverse effects on blood lipid levels, and increased risk of heart attack, stroke, and death.
The recalled products were distributed in either black boxes containing blister packs of 60 capsules or white bottles with black labels containing 30 or 60 capsules.
Customers who have any of the products in their possession should stop using them immediately and contact their physician if they have experienced any problems that may be related to using the products.
Cardiovascular Systems, Inc. and FDA notified healthcare professionals of a nationwide recall of all lots of the ViperSheath Sheath Introducer on behalf of Thomas Medical due to reports about stretching or fracture of the sheath during use.
In the event of a device fracture, separated segments of the device may require unplanned open surgery to remove the retained segments or control bleeding. Since this device is coil reinforced, any separation of the cannula (a flexible tube inserted into the body) has the potential to expose portions of the coil, creating the potential for vessel dissection or perforation.
The recall encompasses products distributed from March 25, 2009 to October 21, 2009, and includes the following lot ranges and catalog numbers:
11-18-09 MedWatch - The FDA Safety Information and Adverse Event Reporting Program
[Posted 11/18/2009] RockHard Laboratories and FDA notified consumers that RockHard Weekend, a product sold as a dietary supplement, contains sulfoaildenafil, an analogue of sildenafil, an FDA-approved drug used as treatment for Erectile Dysfunction. The presence of sulfoaildenafil makes RockHard Weekend an unapproved drug. This undeclared drug ingredient may interact with prescription drugs known as nitrates, including nitroglycerin, and cause dangerously low blood pressure.
RockHard Weekend is sold nationwide in single blisters, 3-count and 8-count bottles. RockHard Laboratories advises any customers in possession of RockHard Weekend to return any unused product for a full refund to the company directly. Customers can call 1.800.562.0543 for instructions on the return and refund process.
The FDA advises consumers who have experienced any adverse events from sexual enhancement products to consult a health care professional.
11-19-09 MedWatch - The FDA Safety Information and Adverse Event Reporting Program
Procter & Gamble and FDA notified consumers of a voluntary recall of three lots of Vicks Sinex Nasal Spray in the United States, Germany and the United Kingdom. The bacteria B. cepacia was found in a small amount of product made at its plant in Gross Gerau, Germany. There have been no reports of illness. However, the bacteria could cause serious infections for individuals with a compromised immune system, or those with chronic lung conditions, such as cystic fibrosis. Consumers should simply discard the affected product as they would any over the counter medicine. Customers who have the affected lots can call P&G for a replacement coupon or refund.
Cardiac Science Corporation has received multiple complaints related to defective components in these AEDs that indicate the affected devices may not deliver electric shocks and that the devices’ self-test may not detect the defect in advance of their use. 300,000 Cardiac Science AEDs worldwide are potentially affected by this problem. The G3 Series devices were manufactured between August 2003 and August 2009. Affected models include the following:
Because the AED display screen and/or audible indicators may not accurately indicate whether the device is functioning properly or will function properly at time of use, FDA encourages users of the affected AEDs to follow the additional precautions provided in this communication. FDA is gathering more data about this situation to better understand its potential public health impact and will make available any new information that might affect the use of these AED devices. Prompt reporting of adverse events can help FDA identify and better understand the risks associated with medical devices.
11-21-09 MedWatch - The FDA Safety Information and Adverse Event Reporting Program
FDA notified healthcare professionals and patients that it is reviewing preliminary data from a recent study suggesting that patients using sibutramine have a higher number of cardiovascular events (heart attack, stroke, resuscitated cardiac arrest, or death) than patients using a placebo (sugar pill). Sibutramine is marketed as Meridia, a prescription drug, in the United States. Meridia was approved by FDA in 1997 for the management of obesity, including weight loss and maintenance of weight loss, in conjunction with a reduced calorie diet. Meridia is only recommended for obese patients with an initial body mass index (BMI) ≥ 30 kg/m2, or BMI ≥ 27 kg/m2 with other risk factors (e.g., diabetes, high cholesterol, controlled high blood pressure).The analysis of these data is ongoing and FDA is making no conclusions about the preliminary findings at this time. These findings highlight the importance of avoiding the use of sibutramine in patients with a history of coronary artery disease (heart disease), congestive heart failure (CHF), arrhythmias, or stroke, as recommended in the current sibutramine labeling.
11-27-09 MedWatch - The FDA Safety Information and Adverse Event Reporting Program
Stryker and FDA notified healthcare professionals of a recall of 23 Operating Room System II Surgical Navigation Systems because there is a potential for the navigation PC SPC-1 component to stop working which could result in the screen freezing, the system updating at a slow rate, or not responding at all. The Navigation System II is a computer aided surgery platform that surgeons can use to perform Hip, Knee, Spine, Neuro and ENT surgical procedures and contains a computer workstation with the navigation System II software and various components necessary to run the system.The potential harms associated with this failure are: delay in surgery, reschedule of the procedure resulting in an additional surgery, risk of infection, increased morbidity, potential neurological deficits, or injury due to the surgeon operating in an area where they did not intend to operate. Depending on the type of surgery, these failures could potentially lead to serious adverse health consequences, including death. Hospitals that have product that corresponds to the catalog numbers above should immediately quarantine the product, label it as a recalled product and stop using the product.
12-02-09 MedWatch - The FDA Safety Information and Adverse Event Reporting Program
Sanofi-Aventis and FDA notified healthcare professionals of changes to the Warnings and Overdosage sections of the Prescribing Information for Norpramin (desipramine hydrochloride), indicated for the treatment of depression. The new safety information states that extreme caution should be used when this drug is given to patients who have a family history of sudden death, cardiac dysrhythmias, and cardiac conduction disturbances; and that seizures precede cardiac dysrhythmias and death in some patients.
12-03-09 MedWatch - The FDA Safety Information and Adverse Event Reporting Program
The FDA notified health care professionals and patients about the increased risk of neural tube defects and other major birth defects, such as craniofacial defects and cardiovascular malformations, in babies exposed to valproate sodium and related products (valproic acid and divalproex sodium) during pregnancy. Healthcare practitioners should inform women of childbearing potential about these risks, and consider alternative therapies, especially if using valproate to treat migraines or other conditions not usually considered life-threatening.
Women of childbearing potential should only use valproate if it is essential to manage their medical condition. Those who are not actively planning a pregnancy should use effective contraception, as birth defect risks are particularly high during the first trimester, before many women know they are pregnant. A valproate Medication Guide, provided with each outpatient prescription, will explain the benefits and risks of valproate and encourage patients to discuss options with their healthcare professional.
FDA notified healthcare facility administrators and infection control healthcare professionals of important information regarding the regulatory status of the STERIS System 1 Processor (SS1) used in surgical and endoscopy suites for reprocessing, i.e., sterilizing or disinfecting, medical devices.
STERIS has significantly modified the SS1 and FDA has not approved or cleared this modified product. Thus, FDA has not determined whether the SS1 is safe or effective for its labeled claims, including claims that it sterilizes medical devices. Use of a device that is promoted to sterilize or disinfect a medical or surgical device, but that does not properly perform these functions, poses risks to patients and users. Improperly disinfected or sterilized instruments may transmit pathogens to patients and healthcare staff, or expose them to hazardous chemicals. Improper sterilization or disinfection may also adversely affect the quality and functionality of reprocessed instruments. FDA has received some reports of malfunctions of the SS1 that had the potential to cause or contribute to serious injuries to patients, such as infections. There have also been reports of injuries, mostly burns from exposure to the sterilant solution, to healthcare facility staff operating the device.
FDA recommends that if a facility has an acceptable alternative to the SS1 to meet sterilization and disinfection needs, the facility should transition to that alternative as soon as possible to ensure continued patient safety. If an acceptable alternative to the SS1 is not available, the facility should promptly assess its patient-care needs and sterilization and disinfection requirements and take steps to obtain legally-marketed substitutes for the SS1.
12-05-09 MedWatch - The FDA Safety Information and Adverse Event Reporting Program
Endo, Novartis and FDA notified healthcare professionals of revisions to the Hepatic Effects section of the Prescribing Information to add new warnings and precautions about the potential for elevation in liver function tests during treatment with all products containing diclofenac sodium.
In postmarketing reports, cases of drug-induced hepatotoxicity have been reported in the first month but can occur at any time during treatment with diclofenac. Postmarketing surveillance has reported cases of severe hepatic reactions, including liver necrosis, jaundice, fulminant hepatitis with and without jaundice, and liver failure. Some of these reported cases resulted in fatalities or liver transplantation.
Physicians should measure transaminases periodically in patients receiving long-term therapy with diclofenac. The optimum times for making the first and subsequent transaminase measurement are not known. Based on clinical trial data and postmarketing experiences, transaminases should be monitored within 4 to 8 weeks after initiating treatment with diclofenac.
12-07-09 MedWatch - The FDA Safety Information and Adverse Event Reporting Program
[UPDATED 12/07/2009] The FDA, working with state and local health authorities, has identified at least 50 additional patients who were exposed to excess radiation of up to eight times the expected level during their CT perfusion scans. These cases so far involve more than one manufacturer of CT scanners. Some of these patients reported hair loss or skin redness following their scans. High doses of radiation can cause cataracts and increase the risk of some forms of cancer.
On the basis of its investigation to date, the FDA is providing interim recommendations for imaging facilities, radiologists, and radiologic technologists to help prevent additional cases of excess exposure.
These recommendations include:
FDA-MedWatch - The Food and Drug Administration
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