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1-25-07 MedWatch - The FDA Safety Information and Adverse Event Reporting Program FDA and Ebek, Inc. notified healthcare professionals and consumers of a voluntary nationwide recall of the company's dietary supplement because the product contains tadalafil, a drug used to treat erectile dysfunction. Liviro3 is not approved by FDA to treat this condition. Tadalafil may interact with nitrates found in some prescription drugs and may lower blood pressure to dangerous levels. Consumers who have Liviro3 should stop using it immediately and contact their physician if they experience any problems that may be related to taking this product.
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1-27-07 MedWatch - The FDA Safety Information and Adverse Event Reporting Program Amgen notified the oncology medical community of the results of a large, multicenter, randomized, placebo-controlled study showing that Aranesp was ineffective in reducing red blood cell transfusions or fatigue in patients with cancer who have anemia that is not due to concurrent chemotherapy. The study also showed higher mortality in patients receiving Aranesp. Aranesp is approved for the treatment of patients with anemia caused by the chemotherapy treatment of the malignant disease and should only be used in accordance with its approved product labeling.
2-02-07 MedWatch - The FDA Safety Information and Adverse Event Reporting Program FDA notified healthcare professionals of the reintroduction of the 2000i Respiratory Gas Humidifier System. This system was recalled in 2005 due to possible contamination with Ralstonia spp. cultures. FDA noted that premature neonates, immunocompromised patients and those with underlying respiratory illness (such as cystic fibrosis) or malignancy may be at particularly high risk for infection if exposed to breathing gases from a contaminated Vapotherm device. FDA issued recommendations for the steps to take before using the reintroduced device.
2-06-07 MedWatch - The FDA Safety Information and Adverse Event Reporting Program FDA informed consumers and healthcare professionals of the potential hazards of using skin numbing products containing topical anesthetic drugs such as lidocaine, tetracaine, benzocaine, and prilocaine in a cream, ointment, or gel. Numbing products are widely used to numb the skin for medical and cosmetic procedures, and to relieve pain, burning and itching due to a variety of medical conditions. FDA has approved many of these products for these uses. Some of these products must be prescribed by a doctor, others may be purchased without a prescription. FDA is aware that use of these products before a cosmetic procedure may not be supervised by trained health professionals. Without this supervision, a patient may apply large amounts of the numbing product to their skin, which can cause life-threatening side effects and death. If a skin numbing product is prescribed or recommended for a procedure, consumers should do the following: - use a topical anesthetic approved by the FDA. - use a topical anesthetic that contains the lowest amount of anesthetic drugs possible that will relieve pain. - ask for instructions from your doctor on how to safely use the topical anesthetic.
2-07-07 MedWatch - The FDA Safety Information and Adverse Event Reporting Program FDA informed healthcare professionals that Custom Ultrasonics agreed to stop manufacturing and distributing its System 83 Plus Washer/Disinfector and the System 83 Plus Mini-flex Washer/Disinfector, used to wash and disinfect flexible endoscopes, until it brings its manufacturing methods and controls into compliance with FDA requirements. Endoscopes that are not properly cleaned and disinfected can be a source of transmission of pathogens between patients, causing life threatening infections. FDA advised health care providers to discontinue using these products, using an alternative device or following appropriate protocols to manually wash and disinfect the device.
2-07-07 MedWatch - The FDA Safety Information and Adverse Event Reporting Program Baxter and FDA notified healthcare professionals of the potential for life threatening medication errors involving two Heparin products, Heparin Sodium Injection 10,000 units/mL, and HEP-LOCK U/P 10 units/mL. Baxter is aware of fatal medication errors that have occurred when two Heparin products with shades of blue labeling were mistaken for each other. Three infant deaths resulted when the higher dosage Heparin Sodium Injection 10,000 units/mL was inadvertently administered instead of the lower dosage of HEP-LOCK U/P 10 units/mL. The currently marketed 1 mL vials of both Heparin products use blue as the prominent background color on their labels.
2-09-07 MedWatch - The FDA Safety Information and Adverse Event Reporting Program HoMedics and FDA notified consumers and healthcare professionals of a nationwide recall of 292,108 heating pads produced by HoMedics and shipped within the United States in 2001 and 2002. Some of the heating pads contain an inadequate connector crimp, which can lead to a high resistance connection that may generate excessive heat. This can pose a risk of minor or first degree burn injuries, fire or damage to the heating pad itself or to materials (like bedding and furniture) that come in contact with the pad. Consumers who have any of the heating pads should discontinue use of the product and return it immediately to the retailer of purchase for a full refund. See recall notice for specific HoMedics Heating Pad Model Numbers.
2-12-07 MedWatch - The FDA Safety Information and Adverse Event Reporting Program FDA and Sanofi-Aventis notified healthcare professionals of revisions to the prescribing information, including a BOXED WARNING and a new Patient Medication Guide, for the antibiotic Ketek. Two of the three previously approved indications, acute bacterial sinusitis and acute bacterial exacerbations of chronic bronchitis, were removed from the prescribing information because the balance of benefits and risks no longer support approval of the drug for these indications. Ketek will remain on the market for the treatment of community acquired pneumonia of mild to moderate severity. In addition, warnings were strengthened for hepatotoxicity (liver injury), loss of consciousness, and visual disturbances. The BOXED WARNING states that Ketek is contraindicated in patients with myasthenia gravis. The Patient Medication Guide, which must be distributed to all patients, informs them about the risks of the drug and how to use it safely.
2-21-07 MedWatch - The FDA Safety Information and Adverse Event Reporting Program Glaxo SmithKline (GSK) notified healthcare professionals of the results of a randomized, double-blind parallel group study [ADOPT] of 4,360 patients with recently diagnosed type 2 diabetes mellitus followed for 4-6 years to compare glycemic control with rosiglitazone relative to metformin and glyburide monotherapies. Significantly more female patients who received rosiglitazone experienced fractures of the upper arm, hand, or foot, than did female patients who received either metformin or glyburide. At GSK's request, an independent safety committee reviewed an interim analysis of fractures in another large; ongoing; controlled clinical trial and preliminary analysis was reported as being consistent with the observations from ADOPT. Healthcare professionals should consider the risk of fracture when initiating or treating female patients with type 2 diabetes mellitus with rosiglitazone.
2-21-07 MedWatch - The FDA Safety Information and Adverse Event Reporting Program FDA notified asthmatic patients and healthcare professionals of new reports of serious and life-threatening allergic reactions (anaphylaxis) in patients after treatment with Xolair. Usually these reactions occur within two hours of receiving a Xolair subcutaneous injection. However, these new reports include patients who had delayed anaphylaxis-with onset two to 24 hours or even longer-after receiving Xolair treatment. Anaphylaxis may occur after any dose of Xolair (including the first dose), even if the patient had no allergic reaction to the first dose. Health care professionals who administer Xolair should be prepared to manage life-threatening anaphylaxis and should observe their Xolair-treated patients for at least two hours after Xolair is given. Patients under treatment with Xolair should be fully informed about the signs and symptoms of anaphylaxis, their chance of developing delayed anaphylaxis following Xolair treatment, and how to treat it when it occurs. FDA has requested Genentech add a boxed warning to the product label and to revise the label and provide a Medication Guide for patients.
2-22-07 MedWatch - The FDA Safety Information and Adverse Event Reporting Program FDA notified healthcare professionals that the manufacturers of all drug products approved for the treatment of Attention Deficit Hyperactivity Disorder (ADHD)have been directed to develop Patient Medication Guides to alert patients to possible cardiovascular risks and risks of adverse psychiatric symptoms associated with the medicines and to advise them of precautions that can be taken. Patient Medication Guides are handouts given to patients, families and caregivers each time a medicine is dispensed. The guides contain FDA-approved patient information that could help prevent serious adverse events.
2-22-07 MedWatch - The FDA Safety Information and Adverse Event Reporting Program Roche and FDA notified cardiac transplant healthcare practitioners about a clinical study (Heart Spare The Nephron) that was terminated due to an observed increased incidence of grade IIIA acute rejection in heart transplant patients switched from calcineurin inhibitor and CellCept to Rapamune (sirolimus) and CellCept at 12 weeks post heart transplantation. The safety and efficacy of CellCept in combination with sirolimus following withdrawal of initial calcineurin inhibitor therapy has not been established.
2-24-07 MedWatch - The FDA Safety Information and Adverse Event Reporting Program FDA and Bristol-Myers Squibb notified healthcare professionals of revisions to the MICROBIOLOGY/Antiviral Activity and INDICATIONS AND USAGE/Description of Clinical Studies/Special Populations sections of the prescribing information for Baraclude. The revised labeling is the result of a case report in which a human immunodeficiency virus (HIV) variant containing the M184V resistance substitution was documented during Baraclude treatment for chronic hepatitis B virus (HBV) infection in an HIV/HBV co-infected patient who was not simultaneously receiving highly active antiretroviral therapy (HAART). Current treatment guidelines recommend Baraclude as an option for treatment of HBV in the HIV/HBV co-infected adult patient who does not qualify for HAART. Healthcare professionals are advised that when considering therapy with Baraclude in an HIV/HBV co-infected patient not receiving HAART, the risk of developing HIV resistance cannot be excluded based on current information.
2-28-07 MedWatch - The FDA Safety Information and Adverse Event Reporting Program Audience: Hospital risk managers, nursing supervisory staff FDA issued a Public Health Notification to further inform hospitals and other user facilities about FDA's action, and to provide recommendations for facilities currently using the affected products to wash and disinfect flexible endoscopes.
3-02-07 MedWatch - The FDA Safety Information and Adverse Event Reporting Program FDA notified healthcare professionals and consumers of the possibility that some medical devices/equipment, hospital networks and associated information technology systems may generate adverse events because of the upcoming change in the start and end dates for Daylight Savings Time (DST), and suggested actions to prevent such occurrences. Medical equipment that uses, creates or records time information about a patient's diagnosis or treatment and has not been updated by the manufacturer, may not work properly when the new DST starts three weeks earlier and ends one week later this year. Medical equipment currently in use was likely made before the DST rules were changed and may cause patient's equipment to register the wrong dates for the start and end of daylight savings time this year. Additionally, if a medical device or medical device network are adversely affected by the new DST date changes, a patient's treatment or diagnostic result could be: -incorrectly prescribed -provided at the wrong time -missed -given more than once -given for longer or shorter durations than intended -incorrectly recorded
3-02-07 MedWatch - The FDA Safety Information and Adverse Event Reporting Program FDA informed healthcare professionals and consumer that the Agency ordered twenty firms to stop marketing unapproved drug products containing ergotamine tartrate. Ergotamine tartrate products are used to treat vascular headaches, including migraines. Unapproved drugs pose real risks to the American public because they have not been subject to FDA review, and the safety, effectiveness, and quality of such products are unknown. This action does not affect FDA-approved products containing ergotamine. Consumers who are using ergotamine products and have questions or concerns are urged to contact their health care provider.
3-05-07 MedWatch - The FDA Safety Information and Adverse Event Reporting Program The Gebauer Company notified healthcare professionals and consumers of a nationwide recall of certain lots of Salivart Oral Moisturizer. The recall was initiated because some lots do not meet the Company's internal specification for aerobic microorganisms and mold. Use of the affected units may cause temporary and reversible health problems such as nausea, vomiting, and diarrhea. Customers who have the recalled product should stop using the product and dispose of it immediately. See the attached Manufacturer's recall notice for specific lot numbers and expiration dates of the recalled product.
3-08-07 MedWatch - The FDA Safety Information and Adverse Event Reporting Program Defibtech and FDA notified healthcare professionals of a worldwide recall of 42,000 Lifeline and ReviveR AEDs with software versions 2.002 and earlier. The self-test software may allow a self-test to clear a detected low battery condition. The operator may be unaware of the low battery and the device may not deliver a defibrillation shock, resulting in failure to resuscitate a patient. The company provided a maintenance procedure that can be used to verify functionality of the device until the software upgrade has been installed, allowing the device to remain in service. The devices were distributed to schools, fire & EMS, businesses, health clubs and hospitality companies.
3-09-07 MedWatch - The FDA Safety Information and Adverse Event Reporting Program Takeda and FDA notified healthcare professionals of recent safety data concerning pioglitazone-containing products. The results of an analysis of the manufacturer's clinical trial database of pioglitazone showed more reports of fractures in female patients taking pioglitazone than those taking a comparator (either placebo or active). The majority of fractures observed in female patients were in the distal upper limb (forearm, hand and wrist) or distal lower limb (foot, ankle, fibula and tibia). There were more than 8100 patients in the pioglitazone-treated groups and over 7400 patients in the comparator-treated groups. The duration of pioglitazone treatment was up to 3.5 years. Healthcare professionals should consider the risk of fracture when initiating or treating female patients with type 2 diabetes mellitus with pioglitazone-containing products.
3-09-07 MedWatch - The FDA Safety Information and Adverse Event Reporting Program FDA notified healthcare professionals of new safety information for erythropoiesis-stimulating agents (ESAs) Aranesp (darbepoetin alfa), Epogen (epoetin alfa), and Procrit (epoetin alfa). Four new studies in patients with cancer found a higher chance of serious and life-threatening side effects or death with the use of ESAs. These research studies were evaluating an unapproved dosing regimen, a patient population for which ESAs are not approved, or a new unapproved ESA. FDA believes these new concerns apply to all ESAs and is re-evaluating how to safely use this product class. FDA and Amgen, the manufacturer of Aranesp, Epogen and Procrit, have changed the full prescribing information for these drugs to include a new boxed warning, updated warnings, and a change to the dosage and administration sections for all ESAs.
3-09-07 MedWatch - The FDA Safety Information and Adverse Event Reporting Program FDA notified healthcare professionals of the early termination of the INSPIRE clinical study of Actimmune for idiopathic pulmonary fibrosis (IPF). The study was stopped because an interim analysis showed that patients with IPF who received Actimmune did not benefit. The trial compared survival in patients getting Actimmune or an inactive injection (placebo). An analysis showed that 14.5% of patients treated with Actimmune died as compared to 12.7% of patients treated with placebo. Actimmune is not approved by the FDA to treat IPF.
3-14-07 MedWatch - The FDA Safety Information and Adverse Event Reporting Program FDA notified healthcare professionals and consumers of its request that all manufacturers of sedative-hypnotic drug products, a class of drugs used to induce and/or maintain sleep, strengthen their product labeling to include stronger language concerning potential risks. These risks include severe allergic reactions and complex sleep-related behaviors, which may include sleep-driving. Sleep driving is defined as driving while not fully awake after ingestion of a sedative-hypnotic product, with no memory of the event. FDA also requested that each product manufacturer send letters to health care providers to notify them about the new warnings, and that manufacturers develop patient Medication Guides for the products to inform consumers about risks and advise them of potential precautions that can be taken.
3-16-07 MedWatch - The FDA Safety Information and Adverse Event Reporting Program FDA notified healthcare professionals of new emerging safety concerns about Zyvox (linezolid) from a recent clinical study. This open-label, randomized trial compared linezolid to vancomycin, oxacillin, or dicloxacillin in the treatment of seriously ill patients with intravascular catheter-related bloodstream infections including those with catheter-site infections. Patients treated with linezolid had a higher chance of death than did patients treated with any comparator antibiotic, and the chance of death was related to the type of organism causing the infection. Patients with Gram positive infections had no difference in mortality according to their antibiotic treatment. In contrast, mortality was higher in patients treated with linezolid who were infected with Gram negative organisms alone, with both Gram positive and Gram negative organisms, or who had no infection when they entered the study. Linezolid is not approved for the treatment of catheter-related bloodstream infections, catheter-site infections, or for the treatment of infections caused by Gram negative bacteria. If infection with Gram negative bacteria is known or suspected, appropriate therapy should be started immediately.
3-16-07 MedWatch - The FDA Safety Information and Adverse Event Reporting Program Cosmos Trading, Inc. and FDA notified consumers and healthcare professionals of a voluntary nationwide recall of a supplement product sold under the name Rhino Max (Rhino V Max) in 5-tablet boxes or 15-tablet boxes. Lab analysis by FDA of product samples found the product contains Aminotadalafil, an analogue of Tadalafil, an FDA-approved drug used to treat Erectile Dysfunction (ED). FDA advised that this poses a threat to consumers because Aminotadalafil 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 Rhino Max (Rhino V Max) 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.
3-19-07 MedWatch - The FDA Safety Information and Adverse Event Reporting Program Barodon SF and FDA notified consumers and healthcare professionals of a voluntary nationwide recall of a supplement product sold under the name V.MAX. Lab analysis by FDA of product samples found the product contains Aminotadalafil, an analogue of Tadalafil, an FDA-approved drug used to treat Erectile Dysfunction (ED). FDA advised that this poses a threat to consumers because Aminotadalafil 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 V.MAX 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.
3-27-07 MedWatch - The FDA Safety Information and Adverse Event Reporting Program FDA notified healthcare professionals of a nationwide Class I recall of RF Denervation probes used with the Smith & Nephew Electrothermal 20S Spine System in RF heat lesion procedures for the relief of pain. The product was mislabeled. The device is a non-sterile (not germ free) device but it was labeled incorrectly as sterile (germ-free). It is a reusable item that is intended to be sterilized (made germ-free) by the medical facility prior to each use, including initial use. This error may result in infections with associated risks including, organ failure and/or death.
3-28-07 MedWatch - The FDA Safety Information and Adverse Event Reporting Program Woodridge Labs and FDA informed consumers and healthcare professionals of a recall of all lots of its DermaFreeze365 Instant Line Relaxing Formula and DermaFreeze365 Neck and Chest products. The products were recalled because certain lots tested positive for Pseudomonas aeruginosa bacteria. The bacteria may cause serious eye infections, urinary tract infections, respiratory system infections, dermatitis, soft tissue infections, bacteremia, bone and joint infections, gastrointestinal infections and a variety of systemic infections, particularly in patients with severe burns and in cancer and AIDS patients who are immunosuppressed. Because DermaFreeze365 Instant Line Relaxing Formula may be applied in the area of the eye, there is a possibility that if the recalled product is inadvertently introduced in the eye, it could result in serious eye infections and, in rare circumstances, possible blindness.
3-28-07 MedWatch - The FDA Safety Information and Adverse Event Reporting Program FDA notified consumers and healthcare professionals of a special webpage launched to warn about the dangers of buying isotretinoin online. Isotretinoin is a drug approved for the treatment of severe acne that does not respond to other forms of treatment. If the drug is improperly used, it can cause severe side effects, including birth defects. Serious mental health problems have also been reported with isotretinoin use. The new webpage, http://www.fda.gov/buyonline/accutane, will appear in online search results for Accutane (isotretinoin) or one of the generic versions, Amnesteem, Claravis, and Sotret. The webpage warns that the drug should only be taken under the close supervision of a physician or a pharmacist, and provides links to helpful information. The new webpage is in addition to special safeguards put in place by FDA and manufacturers of isotretinoin to reduce the risks of the drug, including a risk management program called iPLEDGE. The aim of iPLEDGE is to ensure that women using isotretinoin do not become pregnant, and that women who are pregnant do not use isotretinoin.
3-29-07 MedWatch - The FDA Safety Information and Adverse Event Reporting Program FDA notified healthcare professionals and patients that companies that manufacture and distribute pergolide have agreed to withdraw the drug from the market. Pergolide is a dopamine agonist (DA) used with levodopa and carbidopa to manage the signs and symptoms of Parkinson's disease. Results of two new studies showed that some patients with Parkinson's disease treated with pergolide had serious damage to their heart valves when compared to patients who did not receive the drug. These two studies confirm earlier studies that also described this problem. Patients currently taking pergolide should contact their healthcare professional about alternate treatments and not abruptly stop taking their medication. Healthcare professions should assess their patient's need for DA therapy. If continued treatment with a DA is needed, another DA should be substituted for pergolide.
3-30-07 MedWatch - The FDA Safety Information and Adverse Event Reporting Program FDA notified healthcare professionals and patients that Novartis has agreed to discontinue marketing Zelnorm, a drug used for the short-term treatment of women with irritable bowel syndrome with constipation and for patients younger than 65 years of age with chronic constipation. FDA analysis of safety data pooled from 29 clinical trials involving over 18,000 patients showed an excess number of serious cardiovascular adverse events, including angina, heart attacks, and stroke, in patients taking Zelnorm compared to patients given placebo. Patients taking Zelnorm should contact their healthcare professional to discuss treatment alternatives and seek emergency medical care if they experience severe chest pain, shortness of breath, sudden onset of weakness or difficulty walking or talking, or other symptoms of a heart attack or stroke. Healthcare professionals should assess their patients and transition them to other therapies as appropriate.
4-06-07 MedWatch - The FDA Safety Information and Adverse Event Reporting Program FDA notified healthcare professionals and consumers that companies must stop manufacturing and distributing unapproved suppository drug products containing trimethobenzamide hydrochloride. These products are used to treat nausea and vomiting in adults and children. The products have been marketed under various names, including Tigan, Tebamide, T-Gen, Trimazide, and Trimethobenz. Drugs containing trimethobenzamide in suppository form lack evidence of effectiveness. This action does not affect oral capsules and injectable products containing trimethobenzamide that have been approved by FDA. FDA urges consumers currently using trimethobenzamide suppositories or who have questions or concerns to contact their healthcare professional. Alternative products approved to effectively treat nausea and vomiting are available in a variety of forms.
4-10-07 MedWatch - The FDA Safety Information and Adverse Event Reporting Program Ortho-McNeil and FDA informed healthcare professionals and consumers of a nationwide recall of griseofulvin oral suspension, a prescription medication used to treat ringworm and other fungal infections. The recall was issued based on two reports of glass fragments found in bottles of the liquid formulation. The recall is limited to the liquid formulation of the medication and does not include any other dosage form. Consumers in possession of the medication should contact the pharmacy where they purchased the drug to determine if they have the product that has been recalled and direct medical questions to their healthcare professional.
4-10-07 MedWatch - The FDA Safety Information and Adverse Event Reporting Program GlaxoSmithKline and FDA informed healthcare professionals of an apparent third-party tampering that resulted in the misbranding of Ziagen as Combivir and employed counterfeit labels for Combivir Tablets. Both medications are used as part of combination regimens to treat HIV+ infection. Two 60-count misbranded bottles of Combivir Tablets contained 300 mg tablets of Ziagen. The counterfeit labels identified are Lot No. 6ZP9760 with expiration dates of April 2010 and April 2009. The incident appears to be isolated and limited in scope to one pharmacy in California. Pharmacists should immediately examine the contents of each bottle of Combivir in their pharmacy to confirm that the bottles contain the correct medication.
4-11-07 MedWatch - The FDA Safety Information and Adverse Event Reporting Program Acorda Therapeutics and FDA informed healthcare professionals of changes to the CONTRAINDICATIONS and WARNINGS Sections of the product labeling for Zanaflex, a drug used to treat spasticity, In pharmacokinetic studies where tizanidine was coadministered with either fluvoxamine or ciprofloxacin (CYP1A2 inhibitors), the serum concentration of tizanidine was significantly increased and potentiated its hypotensive and sedative effects. Although there are no clinical studies evaluating the effects of other CYP1A2 inhibitors on tizanidine, coadministration of tizanidine with other CYP1A2 inhibitors (zileuton, other fluroquinolones, antiarrythmics, cimetidine, famotidine, oral contraceptives, acyclovir and ticlopidine) should be avoided.
4-12-07 MedWatch - The FDA Safety Information and Adverse Event Reporting Program Boston Scientific/Guidant and FDA informed healthcare professionals and patients that a subset of devices within the CONTAK RENEWAL 3 & 4, VITALITY and VITALITY 2 families were recalled. The recall included approximately 73,000 implantable cardiac defibrillators and cardiac resynchronization therapy defibrillators because of faulty capacitors. The capacitors may cause accelerated battery depletion and may reduce the time between elective replacement indicator and end of life to less than three months. Although the current recall is similar to the recall of May 2006, the failure modes and patient outcomes differ from those described in the May 2006 recall. Patients with one of the recalled devices should contact their healthcare provider regarding the next steps to take.
5-23-07 MedWatch - The FDA Safety Information and Adverse Event Reporting Program FDA notified healthcare professionals of the Agency's request for the addition of a boxed warning and new warnings about the risk of nephrogenic systemic fibrosis (NSF) to the full prescribing information for all gadolinium-based contrast agents (GBCAs). The new prescribing information FDA is requesting highlights and describes the risk for NSF following exposure to a GBCA in patients with acute or chronic severe renal insufficiency (glomerular filtration rate <30 mL/min/1.73 square meters) and patients with acute renal insufficiency of any severity due to the hepato-renal syndrome or in the peri-operative liver transplantation period. Healthcare professionals should avoid the use of a GBCA in these patients unless the diagnostic information is essential and not available with non-contrast enhanced magnetic resonance imaging.
5-29-07 MedWatch - The FDA Safety Information and Adverse Event Reporting Program Abbott informed consumers and healthcare professionals of a nationwide recall of three lots of two-ounce bottles of Similac Special Care 24 Cal/fl. oz. Ready-to-Feed Premature Infant Formula with Iron, a highly specialized liquid ready-to-feed formula used only for premature infants after discharge from the hospital. The three lots of formula were recalled because they do not contain as much iron as indicated on the label. The formula was distributed in the United States between November 2006 and May 2007. Premature infants fed this formula for more than a month after discharge could have an increased risk of developing anemia due to insufficient iron intake. If parents have concerns about their baby's health, they should contact their baby's doctor or healthcare professional. No other liquid or powdered Similac Infant formulas were affected. See the attached manufacturer's news release for a list of stock code and lot numbers for formula affected by this recall.
5-29-07 MedWatch - The FDA Safety Information and Adverse Event Reporting Program Advanced Medical Optics and FDA informed healthcare professionals and consumers who wear soft contact lenses of a recall of Complete MoisturePlus Multi-Purpose Solution manufactured by Advanced Medical Optics. The recall is based on reports of a rare, but serious, eye infection, Acanthamoeba keratitis, caused by a parasite. The link between the solution and the infection was identified as a result of an investigation by the Centers for Disease Control and Prevention (CDC). Acanthamoeba keratitis may lead to vision loss with some patients requiring a corneal transplant. The infection primarily affects otherwise healthy people who wear contact lenses. Symptoms of the infection can be very similar to those of other more common eye infections include eye pain or redness, blurred vision, light sensitivity, the sensation of something in the ye or excessive tearing, but Acanthamoeba is more difficult to treat. Individuals who wear soft contact lenses should stop using the Advanced Medical Optics Complete MoisturePlus product immediately, discard all remaining solution including partially used or unopened bottles, and ask their healthcare professional about choosing an appropriate alternative cleaning/disinfecting product. Individuals should seek immediate treatment if they have symptoms of an eye infection as early diagnosis is important for effective treatment.
6-01-07 MedWatch - The FDA Safety Information and Adverse Event Reporting Program FDA warned consumers to avoid using tubes of toothpaste labeled as "Made in China". The warning and an import alert were issued to prevent toothpaste containing a poisonous chemical, diethylene glycol (DEG) from entering the United States from China. The substance is used in antifreeze and as a solvent. Although FDA is not aware of any U.S. reports of poisonings from toothpaste containing DEG, FDA is concerned about chronic exposure to DEG and exposure to the product in certain populations, such as children and individuals with kidney or liver disease. Toothpaste containing DEG has a low but meaningful risk of toxicity and injury to these populations. Consumers should examine their toothpaste and dispose of any products listing the ingredient "diethylene glycol" also known as "diglycol" or "diglycol stearate". See the attached News Release for the brands of toothpaste from China that contain DEG that are included in the import alert.
6-05-07 MedWatch - The FDA Safety Information and Adverse Event Reporting Program Alcon Refractive Horizons and FDA notified healthcare professionals and patients of a Class I Recall of the LADAR6000 Excimer Laser System for CustomCornea algorithm for myopia with astigmatism (M3) and myopia without astigmatism (A7). This system is used for LASIK and wave-front guided LASIK treatment for the reduction or elimination of mild to moderate nearsightedness (myopia) and farsightedness (hyperopia) with or without astigmatism or for mixed astigmatism in patients who are 21 years of age or older with documented stability of refraction for the prior 12 months. The product was recalled because use of the Alcon Refractive Horizons CustomCornea algorithm for myopia with and without astigmatism with the LADAR6000 Excimer Laser caused corneal abnormalities ("central islands") and decreased visual sharpness (visual acuity) in patients with myopia with and without astigmatism. These "central islands" may not be correctable with lasers and the decrease in visual acuity may not be correctable with glasses or contact lenses. Patients with questions should call the company at 1-877-523-2784.
6-08-07 MedWatch - The FDA Safety Information and Adverse Event Reporting Program Abbott Laboratories and FDA notified healthcare professionals of a Class I Recall of all lots of the Architect Stat Troponin-1 Immunoassay. Doctors use this test in diagnosing damage to the heart and/or a heart attack in people who have had chest pain. The product was recalled after a small number of clinical laboratories reported inconsistent or invalid test results at very low levels of troponin-1 (i.e., less than 0.1ng/mL). The assay may report falsely elevated or falsely decreased results at and near this low level, which may impact patient treatment. Laboratories are advised to be cautious when reporting results at or near the lower limit of detection and to advise physicians ordering the tests about the possibility of inaccurate results at those levels.
6-15-07 MedWatch - The FDA Safety Information and Adverse Event Reporting Program FDA informed healthcare professionals about several clusters of patients who experienced chills, fever, and body aches shortly after receiving propofol for sedation or general anesthesia. Multiple vials and several lots of propofol used in patients who experienced these symptoms were tested and there was no evidence that the propofol vials or prefilled syringes used were contaminated with bacteria or endotoxins. Propofol is an intravenous sedative-hypnotic agent for use in the induction and maintenance of anesthesia or sedation. To minimize the potential for bacterial contamination, propofol vials and prefilled syringes should be used within six hours of opening and one vial should be used for one patient only. Patients who develop fever, chills, body aches or other symptoms of acute febrile reactions shortly after receiving propofol should be evaluated for bacterial sepsis. Healthcare professionals who administer propofol for sedation or general anesthesia should carefully follow the recommendations for handling and use in the product's full prescribing information.
6-15-07 MedWatch - The FDA Safety Information and Adverse Event Reporting Program FDA informed healthcare professionals of changes to the ADVERSE REACTIONS and POST-MARKETING sections of the product's prescribing information. The ADVERSE REACTIONS section was updated to include six cases of Kawasaki disease that were observed during the Phase 3 clinical trial. There were five cases among the 36,150 infants who received RotaTeq and one case among the 35,536 infants who received placebo. The POST-MARKETING section of the prescribing information was revised to reflect three reports of Kawasaki disease to the Vaccine Adverse Event Reporting System (VAERS) since licensure on February 3, 2006. There is not a known cause and effect relationship between receiving RotaTeq, or any vaccine and the occurrence of Kawasaki disease. Kawasaki disease is a serious, but uncommon illness in children that is poorly understood and the cause has not been determined. It is characterized by high fever and inflammation of the blood vessels and affects the lymph nodes, skin, mouth and heart. The cases reported to date are not more frequent than what could be expected to occur by coincidence. FDA and the Centers for Disease Control and Prevention will continue to monitor the safety of RotaTeq and all vaccines and encourage that all severe adverse events, including any additional cases of Kawasaki disease after administration of RotaTeq, as well as other vaccines, be reported to VAERS.
6-28-07 - MedWatch - The FDA Safety Information and Adverse Event Reporting Program FDA notified healthcare professionals and cystic fibrosis patients that the Agency is investigating the possible connection between the use of a liquid solution of Colistimethate that was premixed for inhalation with a nebulizer and the death of a patient with cystic fibrosis (CF). Colistimethate is FDA approved for intravenous or intramuscular injection for the treatment of acute or chronic infections due to sensitive strains of certain Gram-negative bacilli, particularly sensitive strains of Pseudomonas aeruginosa which are a significant problem for patients with CF and for patients with neutropenia, and/or immune system compromise. The product is not FDA approved for use as a liquid to be inhaled via nebulizer. In this case, the drug was prepared by a pharmacy and dispensed as prescribed in premixed unit dose ready-to-use vials. Once Colistimethate is mixed into a liquid form, the product breaks down into other chemicals that can damage lung tissue. Healthcare professionals who choose to prescribe Colistimethate to treat patients with CF should be aware of the potential for serious and life threatening side effects from inhalation of pre-mixed, ready-to-use liquid forms of the product. Patients should discard any unused pre-mixed liquid forms of Colistimethate.
7-05-07 MedWatch - The FDA Safety Information and Adverse Event Reporting Program Merck and FDA informed healthcare professionals that 3 lots of Invanz (0803930, 0803940, and 0803950), a product indicated for the treatment of patients with moderate to severe infections caused by susceptible isolates of the designated microorganisms, were recalled. The product was recalled because of two incidents of finding broken glass pieces in the reconstituted solution for injection. Healthcare professionals are advised to immediately stop dispensing all products from the three lots specified above. No other lots are affected by this recall.
7-05-07 MedWatch - The FDA Safety Information and Adverse Event Reporting Program Roche and FDA informed healthcare professionals of revisions to the CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS and DOSAGE AND ADMINISTRATION sections of the prescribing information for Rocephin for Injection. The revisions are based on new information that describes the potential risk associated with concomitant use of Rocephin with calcium or calcium containing solutions or products. Cases of fatal reactions with calcium-ceftriaxone precipitates in the lungs and kidneys in both term and premature neonates were reported. Hyperbilirubinemic neonates, especially prematures, should not be treated with Rocephin. The drug must not be mixed or administered simultaneously with calcium-containing solutions or products, even via different infusion lines. Additionally, calcium-containing solutions or products must not be administered within 48-hours of the last administration of ceftriaxone.
7-09-07 MedWatch - The FDA Safety Information and Adverse Event Reporting Program Please note that the recall notice for INVANZ dated July 5, 2007, was inadvertently submitted to the wrong server. We apologize for any inconvenience this may have caused. We are resending the notice to the appropriate server via this notification. Merck and FDA informed healthcare professionals that 3 lots of Invanz (0803930, 0803940, and 0803950), a product indicated for the treatment of patients with moderate to severe infections caused by susceptible isolates of the designated microorganisms, were recalled. The product was recalled because of two incidents of finding broken glass pieces in the reconstituted solution for injection. Healthcare professionals are advised to immediately stop dispensing all products from the three lots specified above. No other lots are affected by this recall.
7-13-07 MedWatch - The FDA Safety Information and Adverse Event Reporting Program Bayer Healthcare and FDA notified healthcare professionals and consumers of a Class 1 Recall of Bayer Ascensia Contour Blood Glucose Monitoring System, Product 7152A. This system is used by diabetic patients to measure the amount of glucose in their blood, and as an aid in monitoring the effectiveness of diabetes management. The product was recalled because the meters reported the wrong units of measure for Canadian users. Instead of mmol/L, which is the appropriate measurement for Canadian users, the meters were reporting mg/dL. Consumers may misinterpret the blood glucose results displayed, overestimate the blood glucose levels, and may have a reaction of hypoglycemia. Patients with questions should call Bayer Healthcare at 1-574-256-3441.
7-20-07 MedWatch - The FDA Safety Information and Adverse Event Reporting Program Baxter Healthcare Corp. and FDA notified healthcare professionals and consumers of a Class I Recall of Baxter Upgraded COLLEAGUE Triple Channel Volumetric Infusion Pumps, Model numbers 2M8153, 2M8163, and 2M9163. These electronic infusion pumps are used to deliver controlled amounts of medications or other fluids to patients through an intravenous (IV), intra-arterial (IA), epidural, or other direct line into the bloodstream. The product was recalled because a software irregularity causes the newly upgraded COLLEAGUE Triple Channel Volumetric Infusion Pumps to alarm, display an error code (16:310:867:0002) and stop the infusion. This occurs during user programming with all three channels infusing fluids at the same time. There are reports of serious injuries that are associated with this issue. In reported cases, the pump stopped infusing which caused it to activate an audible and a visual alarm. Interruption of life-sustaining therapy could lead to serious injury or death. Remove all the affected triple channel pumps from service immediately. COLLEAGUE customers with questions should contact Baxter Medical Delivery Services at 1-800-843-7867.
7-27-07 MedWatch - The FDA Safety Information and Adverse Event Reporting Program Thoratec Corporation and FDA notified healthcare professionals and patients of a Class I Recall of Thoratec Paracorporeal Ventricular Assist System (PVAD), Model TLC-II, Catalog No. 14086-2550-000. A ventricular assist device is a mechanical pump that helps a person's heart that is too weak to pump blood through the body. The VAD is designed to provide sufficient blood flow to the damaged or diseased heart. The product was recalled because the PVAD may contain a black collet (circular rim) that holds a rod-like piece in place (nut). This black collet and nut was intended to be used with a cannula (a small tube) of an older design that had a larger diameter. If this black collet and nut is used with the current design of cannula that has a smaller diameter, it can disconnect during use. Dispose of any expired original design cannula. Do not use the black collet and nut with any design VAD. Make sure that all current patients using PVADs are using the white collet nut that is packaged with the cannula. Patients may call Thoratec Corporation at 1-925-847-8600.
7-27-07 MedWatch - The FDA Safety Information and Adverse Event Reporting Program FDA announced that it is permitting the restricted use of Zelnorm under a treatment investigational new drug (IND) protocol to treat irritable bowel syndrome with constipation (IBS-C) and chronic idiopathic constipation (CIC) in women younger than 55 who meet specific guidelines. In some instances, patients with a serious or life-threatening disease or condition who are not enrolled in a clinical trial may be treated with a drug not approved by the FDA. Generally, such use is allowed within guidelines called a treatment IND, when no comparable or satisfactory alternative drug or therapy is available. These patients must meet strict criteria and have no known or pre-existing heart problems and be in critical need of this drug. Zelnorm will remain off the market for general use. Physicians with IBS-C or CIC patients, who meet the IND criteria should contact Novartis at 888-669-6682 or 800-QUI-NTILE. Those who do not qualify for the Zelnorm treatment protocol may contact FDA's Division for Drug Information about other options at 888-463-6332.
7-27-07 MedWatch - The FDA Safety Information and Adverse Event Reporting Program Baxter Healthcare and FDA notified healthcare professionals and consumers of a Class I Recall of Baxter COLLEAGUE and FLO-GARD Volumetric Infusion Pumps, Model numbers 2M8151 and 2M8153, COLLEAGUE CX Volumetric Infusion Pumps, Model numbers 2M8161 and 2M8163, and FLO-GARD Volumetric Infusion Pumps Model numbers 2M8063 and 2M8064. The products were recalled because the firm identified repair, inspection, test data sheets, which included electrical safety data for the pumps, that were falsified. As a result it is possible that pumps sent to be serviced, repaired or corrected were returned without service being performed on them. This may result in over/under infusion, failure to detect an upstream or downstream occlusion, electrical shock hazard, failure to detect air in line and malfunctions where the pump will stop infusing and result in an interruption of therapy that can lead to death. Return the affected pumps to Baxter Healthcare for repeat inspections and servicing. COLLEAGUE and FLO-GARD customers with questions should contact Baxter Healthcare Corp. at 1-800-422-4770.
8-01-07 MedWatch - The FDA Safety Information and Adverse Event Reporting Program FDA announced that many consumers may not be aware of the May 2007 recall of Complete MoisturePlus Multipurpose Contact Lens Solution manufactured by Advanced Medical Optics (AMO) and continue to use the recalled product. Several cases of Acanthamoeba Keratitis have been reported to CDC that involve the use of AMO Complete MoisturePlus after the recall was announced. Individuals who wear soft contact lenses should stop using the Advanced Medical Optics Complete MoisturePlus product immediately, discard all remaining solution including partially used or unopened bottles. See the FDA Preliminary Public Health Notification dated May 31, 2007, for recommendations for contact lens wearers.
8-09-07 MedWatch - The FDA Safety Information and Adverse Event Reporting Program FDA issued an early communication about the ongoing review of new safety data for the proton pump inhibitors, Prilosec and Nexium. The new safety data was from two small long-term clinical studies in patients with severe GERD. In both studies, patients were randomly assigned to receive treatment with a drug (either omeprazole or esomeprazole) or to have surgery to control their gastroesophageal reflux disease (GERD). The results from the study of Prilosec and analyses from an ongoing study of Nexium raised concerns that long-term use of Prilosec or Nexium may have increased the risk of heart attacks, heart failure, and heart-related sudden death in those patients taking either one of the drugs compared to patients who received surgery. After reviewing these and other data submitted by the company, FDA's preliminary conclusion at this time, is that collectively, these data do not suggest an increased risk of heart problems for patients treated with omeprazole or esomeprazole. Healthcare providers should not change their prescribing practices and patients should not change their use of these products at this time. Both drugs are used for the treatment of GERD, esophageal erosions and for maintenance of healing erosions of the esophagus. They are also used for the treatment of ulcers. Prilosec is also sold over the counter for frequent heartburn.
8-09-07 MedWatch - The FDA Safety Information and Adverse Event Reporting Program FDA warns consumers and healthcare professionals to avoid using Red Yeast Rice and Red Yeast Rice/Policosonal Complex, sold by Swanson Healthcare Products, Inc. and manufactured by Nature's Value Inc. and Kabco Inc., respectively; and Cholestrix, sold by Sunburst Biorganics because the products may contain an unauthorized drug that could be harmful to their health. The products, promoted and sold over the internet as treatments for high cholesterol, contain lovastatin, the active pharmaceutical ingredient in Mevacor, a prescription drug approved for high cholesterol. Lovastatin can cause severe muscle problems leading to kidney impairment. The risk is greater in patients who take higher doses of lovastatin or who take lovastatin and other medicines that increase the risk of muscle adverse reactions such as nefazodone (an antidepressant), certain antibiotics, drugs used to treat fungal infections and HIV infections, and other cholesterol lowering agents. Consumers who use any red yeast rice products should consult their healthcare provider if they experience any problems that may be due to these products.
8-14-07 MedWatch - The FDA Safety Information and Adverse Event Reporting Program Abbott Laboratories disseminated a Dear Healthcare Provider Letter throughout the world to physicians and pharmacists that prescribe/distribute Kaletra Oral Solution. The letter informed healthcare professionals of an accidental overdose that occurred with a pediatric patient taking Kaletra Oral Solution. The infant received a significantly large dose of Kaletra and subsequently died. Healthcare professionals should pay special attention to accurate calculation of the dose of Kaletra, transcription of the medication order, dispensing information and dosing instructions to minimize the risk for medication errors.
8-14-07 MedWatch - The FDA Safety Information and Adverse Event Reporting Program After a review of postmarketing adverse event reports, FDA determined that an updated label with a boxed warning on the risks of heart failure was needed for the entire thiazolidinedione class of antidiabetic drugs. These drugs are used in conjunction with diet and exercise to improve blood sugar control in adults with type 2 (non-insulin-dependent) diabetes. Manufacturers of certain drugs have agreed to the upgraded warning. The strengthened warning advises healthcare professionals to observe patients carefully for the signs and symptoms of heart failure, including excessive, rapid weight gain, shortness of breath, and edema after starting drug therapy. Patients with these symptoms who then develop heart failure should receive appropriate management of the heart failure and use of the drug should be reconsidered. People who have questions should contact their healthcare providers to discuss alternative treatments.
8-15-07 MedWatch - The FDA Safety Information and Adverse Event Reporting Program FDA announced that on October 18 - 19, 2007, the Nonprescription Drugs Advisory Committee will discuss the safety and effectiveness of cough and cold drug product use in children. Questions have been raised about the safety of these products and whether the benefits justify any potential risks from the use of these products in children, especially in children under two years of age. In preparation for the meeting, FDA is reviewing safety and efficacy data for the ingredients of these products. Some reports of serious adverse events associated with the use of these products appear to be the result of giving too much of these medicines to children. An over-the-counter cough and cold medicine can be harmful if more than the recommended amount is used, if it is given too often, or if more than one cough and cold medicine containing the same active ingredient are being used. To avoid giving a child too much medicine, parents must carefully follow the directions for use of the product in the "Drug Facts" box on the package label. The Public Health Advisory offers parents and caregivers of children recommendations when using cough and cold products in children.
8-16-07 MedWatch - The FDA Safety Information and Adverse Event Reporting Program FDA and Bristol-Myers Squibb notified healthcare professionals of revisions to the following sections of the Baraclude prescribing information: BOXED WARNINGS, MICROBIOLOGY/Antiviral Activity against HIV (human immunodeficiency virus), WARNINGS/Co-infection with HIV, PRECAUTIONS/Information for Patients, and Patient Package Insert. Baraclude therapy is not recommended for HIV/hepatitis B virus (HBV) co-infected patients who are not also receiving highly active antiretroviral therapy (HAART) due to the potential for the development of HIV resistance.
8-16-07 MedWatch - The FDA Safety Information and Adverse Event Reporting Program FDA approved updated labeling to include pharmacogenomics information to the CLINICAL PHARMACOLOGY, PRECAUTIONS, and DOSAGE AND ADMINISTRATION sections of the prescribing information for the widely used blood-thinning drug, Coumadin. This new information explains that people's genetic makeup may influence how they respond to the drug. Specifically, people with variations in two genes may need lower warfarin doses than people without these genetic variations. The two genes are called CYP2C9 and VKORC1. The CYP2C9 gene is involved in the breakdown (metabolism) of warfarin and the VKORC1 gene helps regulate the ability of warfarin to prevent blood from clotting. The dosage and administration of warfarin must be individualized for each patient according to the particular patient's prothrombin time (PT) / International Normalized Ratio (INR) response to the drug. The specific dose recommendations are described in the warfarin product labeling, along with the new information regarding the impact of genetic information upon the initial dose and the response to warfarin. Ongoing warfarin therapy should be guided by continued INR monitoring.
8-17-07 MedWatch - The FDA Safety Information and Adverse Event Reporting Program FDA issued a Public Health Advisory with important new information about a very rare, but serious, side effect in nursing infants whose mothers are taking codeine and are ultra-rapid metabolizers of codeine. When codeine enters the body and is metabolized, it changes to morphine, which relieves pain. Many factors affect codeine metabolism, including a person's genetic make-up. Some people have a variation in a liver enzyme and may change codeine to morphine more rapidly and completely than other people. Nursing mothers taking codeine may also have higher morphine levels in their breast milk. These higher levels of morphine in breast milk may lead to life-threatening or fatal side effects in nursing babies. In most cases, it is unknown if someone is an ultra-rapid codeine metabolizer. When prescribing codeine-containing drugs to nursing mothers, physicians should choose the lowest effective dose for the shortest period of time and should closely monitor mother-infant pairs. There is an FDA cleared test for determining a patient's CYP2D6 genotype. The test is not routinely used in clinical practice but is available through a number of different laboratories. The results of this test predict that a person can convert codeine to morphine at a faster rate than average, resulting in higher morphine levels in the blood. When levels of morphine are too high, patients have an increased risk of adverse events.
8-21-07 MedWatch - The FDA Safety Information and Adverse Event Reporting Program Confidence Inc. informed consumers and healthcare professionals that the company is recalling one lot of METABOLISM Apple Cider Vinegar Brand Dietary Supplement Capsules (Lot: 3001006, Exp. 10/2009) because the product contains the undeclared drug ingredient sibutramine, an FDA approved drug used as an appetite suppressant for weight loss. The FDA has not approved METABOLISM Apple Cider Vinegar Brand Dietary Supplement Capsules as a drug, therefore the safety and effectiveness of this product is unknown. The use of sibutramine may pose a threat to consumers because it 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 should return any unused product to the manufacturer.
9-07-07 MedWatch - The FDA Safety Information and Adverse Event Reporting Program Bodee LLC, Inc., issued a nationwide recall of Zencore Tabs, a product marketed as a dietary supplement, because it contains undeclared ingredients. FDA laboratory analysis of Zencore Tabs found that the product contains aminotadalafil, an analog of tadalafil, and sildenafil, both of which are active ingredients of FDA-approved drugs used for Erectile Dysfunction. The product also contained sulfosildenafil and sulfohomosildenafil which are analogs of sildenafil. All of these undeclared chemicals pose a threat to consumers because they may interact with nitrates found in some prescription drugs (such as nitroglycerin) and may lower blood pressure to dangerous levels. Consumers who have this product should stop using it immediately and consult their healthcare professional if they experience any problems that may be due to this product.
9-10-07 MedWatch - The FDA Safety Information and Adverse Event Reporting Program Pfizer issued a Dear Healthcare Professional Letter to inform healthcare professionals of the presence of ethyl methanesulfonate (EMS), a process-related impurity in Viracept and to provide guidance on the use of Viracept in pregnant women and pediatric patients. EMS is a potential human carcinogen. Data from animal studies indicate EMS is teratogenic, mutagenic and carcinogenic; however, no data from humans exist. FDA has asked Pfizer to implement new specifications to limit the presence of EMS in Pfizer-manufactured Viracept products marked in the United States. For pediatric patients who are stable on Viracept-containing regimens, FDA and Pfizer agree that the benefit-risk ratio remains favorable and those patients may continue to receive Viracept. Pediatric patients who need to begin HIV treatment should not start regimens containing Viracept until further notice. Pregnant women who need to begin antiretroviral therapy should not be offered regimens containing Viracept until further notice. As a precautionary measure, pregnant women currently receiving Viracept should be switched to an alternative antiretroviral therapy while Pfizer and FDA work to implement the long term EMS specification for Viracept. For pregnant women with no alternative treatment options, FDA and Pfizer agree that the risk-benefit ratio remains favorable for the continued use of Viracept.
9-11-07 MedWatch - The FDA Safety Information and Adverse Event Reporting Program Roche informed healthcare professionals about revisions made to the prescribing information for Rocephin to clarify the potential risk associated with concomitant use of Rocephin with calcium or calcium-containing solutions or products. Healthcare professionals are advised that Rocephin and calcium-containing solutions including continuous calcium-containing infusions such as parenteral nutrition, should not be mixed or co-administered to any patient irrespective of age, even via different infusion lines at different sites. Rocephin and IV calcium-containing solutions should not be administered within 48 hours of each other in any patient. No data are available on the potential interaction between ceftriaxone and oral calcium-containing products or interaction between intramuscular ceftriaxone and calcium-containing products (IV or oral).
9-11-07 MedWatch - The FDA Safety Information and Adverse Event Reporting Program Abbott notified users of Precision Xtra, Optium, ReliOn Ultima, Rite Aid, and Kroger blood glucose meters (manufactured after January 31, 2007), to check display screen of the meter to make sure that it is working properly. If meters are dropped onto a hard surface, part of the display can be jarred or disconnected, thereby making it difficult to read the lot number or date information. Additionally, dropping the meter can cause the screen to appear blank, which could result in an inability to view blood glucose test results. The inability to generate blood glucose results may cause a significant risk for hypoglycemia or hyperglycemia. Users of these meters who note that the display screen is not working properly should immediately stop using their meter. Patients should keep their glucose meters in the wallet provided to offer additional protection for the meter. If the meter is dropped on a hard surface, patients should immediately perform a meter display check. Instructions on how to do this are detailed in the meter's Users Guide. If no problems are encountered during the automatic display check, the meter is ready for use.
9-13-07 MedWatch - The FDA Safety Information and Adverse Event Reporting Program Cephalon issued two Dear Healthcare Professional Letters to inform prescribers and other healthcare providers of important safety information regarding Fentora. Fentora is indicated only for the management of breakthrough pain in patients with cancer who are already receiving and who are tolerant to opioid therapy for their underlying persistent cancer pain. Serious adverse events, including deaths, have occurred in patients treated with Fentora. These deaths occurred as a result of improper patient selection (e.g., use in opioid non-tolerant patients), improper dosing, and/or improper product substitution. The healthcare professional letters provide key points regarding appropriate patient selection and proper dosing and administration of Fentora to reduce the risk of respiratory depression.
9-14-07 MedWatch - The FDA Safety Information and Adverse Event Reporting Program B. Braun Medical Inc., issued a recall of Normal Saline Flush Syringes with lot numbers ending in "SFR" due to an increase in customer complaints of particulate matter in the saline. The introduction of particular matter into the blood stream may result in phlebitis and/or damage to vital organs such as the brain, kidneys, heart and lungs. To a less likely extent, there is also a potential for the development of pulmonary embolism or silicone embolism syndrome, which could cause sever injury and/or death. To date, B. Braun has received no reports of any patient injury associated with this issue. Customers that have the recalled product in their possession should discontinue use immediately and contact their physician if they have experienced any problems that may be related to the usage of this product.
9-18-07 MedWatch - The FDA Safety Information and Adverse Event Reporting Program FDA issued a Class I recall for MRL/Welch Allyn AED 20 Automatic External Defibrillators manufactured between October 2003 and January 2005, serial numbers 205787 through 207509. These devices are used by emergency or medical personnel to treat adult and pediatric patients in cardiopulmonary arrest (heart attack). The recalled devices may display a "Defib Comm" error message on the device display during use which may result in a terminal failure of the device to analyze the patient's ECG and deliver the appropriate therapy. FDA advises healthcare professionals and patients to stop using the recalled product and contact the manufacturer for a replacement.
9-21-07 MedWatch - The FDA Safety Information and Adverse Event Reporting Program MOM Enterprises Inc., and FDA informed consumers and healthcare providers that Baby's Bliss Gripe Water, apple flavor, with a code of 26952V and expiration date of October 2008 (10/08) is being recalled due to the presence of Cryptosporidium infection. The product is labeled Baby's Bliss. Pediatrician Recommended Gripe Water. Apple Flavor. An herbal supplement used to ease the gas and stomach discomfort often associated with colic, hiccups, and teething in infants and children. FDA is investigating the illness of a 6-week old infant who consumed the product. The most common symptom of Cryptosporidium infection is watery diarrhea. Other symptoms include dehydration, weight loss, stomach cramps or pain, fever, nausea, and vomiting. Symptoms generally begin two to ten days after becoming infected with the parasite and generally last one to two weeks. The infection could be life-threatening for certain individuals, including infants, children, and individuals with weakened immune systems. FDA advises parents/caregivers of children who have recently consumed Baby's Bliss Gripe Water, apple flavor, and have these symptoms to seek immediate medical attention. Parents and caregivers who have given this product to their infants and children should be alert for diarrhea and other signs of Cryptosporidium infection. FDA advises consumers to stop using this product and throw away bottles of the product immediately.
9-21-07 MedWatch - The FDA Safety Information and Adverse Event Reporting Program TWC Global LLC, Inc., issued a nationwide recall of Axcil and Desirin, both marketed as dietary supplements, because they contain potentially harmful, undeclared ingredients. FDA laboratory analysis of Axcil and Desirin found that the lot of 02B07 contained 3mg/g of sildenafil, the active ingredient of a FDA approved drug used for Erectile Dysfunction (ED). The products also contained sulfosildenafil and sulfohomosildenafil, which are analogs of sildenafil. All of these undeclared chemicals pose a threat to consumers because they 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. Sexual dysfunction is a common problem in men and women with these conditions, and consumers may seek these types of products to enhance sexual performance. Consumers who have these products should stop using them immediately and consult their healthcare professional if they experience any problems that may be due to these products.
9-27-07 MedWatch - The FDA Safety Information and Adverse Event Reporting Program Baxa Corporation and FDA informed healthcare professionals of a class I recall of Exacta-Mix 2400 Operating Software Version 1.07, Model No. 8300-0073, Pharmacy Compound System. The device is a compounding system that can be used in pharmacies to add and mix various ingredients into one intravenous (IV) solution. The device is being recalled because a software failure allowed up to 50mL extra volume of an ingredient to be added to the IV solution that can be life-threatening, particularly in newborns. FDA advises healthcare professionals to stop using this product and contact the manufacturer for a replacement.
9-28-07 MedWatch - The FDA Safety Information and Adverse Event Reporting Program FDA informed healthcare professionals and consumers of its intent to take action against companies that market unapproved prescription products containing hydrocodone, a narcotic widely used as a cough suppressant and to treat pain. The drug has also been an extremely popular drug of abuse and can lead to serious illness, injury, or death, if improperly used. Hydrocodone overdose can result in breathing problems or cardiac arrest, and its use may impair motor skills and judgment. The FDA has received reports of medication errors associated with formulation changes in unapproved hydrocodone products and reports of confusion over the similarity of the names of unapproved products to approved drug products. Most of the hydrocodone formulations now marketed to suppress coughs have not been approved. The agency is particularly concerned about improper pediatric labeling of unapproved hydrocodone cough suppressants (also known as antitussives), and the risk of medication error involving the unapproved products. No hydrocodone cough suppressant has been established as safe and effective for children under 6 years of age and some of these unapproved products carry labels with dosing instructions for children as young as 2 years of age. Anyone marketing unapproved hydrocodone products that are currently labeled for use in children younger than 6 years of age must end further manufacturing and distribution of the products on or before October 31, 2007. Those marketing any other unapproved hydrocodone drug products must stop manufacturing such products on or before December 31, 2007, and must cease further shipment in interstate commerce on or before March 31, 2008. Further legal action could be taken against those failing to meet these deadlines. There are a number of alternatives for patients who might be using unapproved hydrocodone cough suppressants. Consumers should consult a healthcare professional for detailed guidance on treatment options.
10-01-07 MedWatch - The FDA Safety Information and Adverse Event Reporting Program FDA issued an early communication about the ongoing review of new safety data regarding the association of atrial fibrillation with the use of bisphosphonates. Bisphosphonates are a class of drugs used primarily to increase bone mass and reduce the risk for fracture in patients with osteoporosis, slow bone turnover in patients with Paget's disease of the bone, treat bone metastases, and lower elevated levels of blood calcium in patients with cancer. FDA reviewed spontaneous postmarketing reports of atrial fibrillation reported in association with oral and intravenous bisphosphonates and did not identify a population of bisphosphonate users at increased risk of atrial fibrillation. In addition, as part of the data review for the recent approval of once-yearly Reclast for the treatment of postmenopausal osteoporosis, FDA evaluated the possible association between atrial fibrillation and the use of Reclast. Most cases of atrial fibrillation occurred more than a month after drug infusion. Also, in a subset of patients monitored by electrocardiogram up to the 11th day following infusion, there was no significant difference in the prevalence of atrial fibrillation between patients who received Reclast and patients who received placebo. Upon initial review, it is unclear how these data on serious atrial fibrillation should be interpreted. Therefore, FDA does not believe that healthcare providers or patients should change either their prescribing practices or their use of bisphosphonates at this time.
11-05-07 - MedWatch - The FDA Safety Information and Adverse Event Reporting Program FDA issued a Class I recall for Welch Allyn AED 10 Automatic External Defibrillators manufactured between March 29, 2007 and August 9, 2007, part numbers 970302E, 970308E, 970310E, and 970311E. These devices are used by emergency or medical personnel, or by others who have taken the appropriate training in cardiopulmonary arrest (heart attack). They analyze an unconscious patient's heart rhythm and automatically deliver an electrical shock to the heart if needed to restore normal heart rhythm. There is a possibility that these recalled devices may experience failure or unacceptable delay in analyzing a patient's ECG resulting in possible failure to deliver the appropriate therapy. The possible failure or delay depends on the location of the defective part that stores an electrical charge on the circuit board. The company plans to replace all affected units and has set up a call center for customers.
11-05-07 - MedWatch - The FDA Safety Information and Adverse Event Reporting Program FDA announced that, at the agency's request, Bayer Pharmaceuticals Corp. has agreed to a marketing suspension of Trasylol (aprotinin injection), a drug used to control bleeding during heart surgery, pending detailed review of preliminary results from a Canadian study that suggested an increased risk for death. FDA requested the suspension in the interest of patient safety based on the serious nature of the outcomes suggested in the preliminary data. FDA has not yet received full study data but expects to act quickly with Bayer, the study's researchers at the Ottawa Health Research Institute, and other regulatory agencies to undertake a thorough analysis of data to better understand the risks and benefits of Trasylol. Until FDA can review the data from the terminated study it is not possible to determine and identify a population of patients undergoing cardiac surgery for which the benefits of Trasylol outweigh the risks. However, understanding that individual doctors may identify specific cases where benefit outweighs risk, FDA is committed to exploring ways for those doctors to have continued, limited access to Trasylol. There are not many treatment options for patients at risk for excessive bleeding during cardiac surgery. Thus, FDA is working with Bayer to phase Trasylol out of the marketplace in a way that does not cause shortages of other drugs used for this purpose.
11-14-07 - MedWatch - The FDA Safety Information and Adverse Event Reporting Program
FDA issued an early communication about the ongoing review of new safety data and the request for additional data to further evaluate the risk of death in patients treated with cefepime. An article in the May 2007 issue of The Lancet Infectious Diseases (Efficacy and safety of cefepime: a systematic review and meta-analysis) raised the question about increased mortality with the use of cefepime, a broad spectrum B-lactam antibiotic currently approved for the treatment of a variety of infections due to susceptible strains of microorganisms. The article describes a higher all-cause mortality in patients treated with cefepime compared to other B-lactam antibiotics. Until FDA's evaluation is completed, healthcare professionals who are considering the use of cefepime should be aware of the risks and benefits described in the prescribing information and the new information from this meta-analysis.
FDA informed healthcare professionals of new information added to the existing boxed warning in Avandia's prescribing information about potential increased risk for heart attacks. The new information refers to a meta-analysis of 42 clinical studies, most of which compared Avandia to placebo, that showed Avandia to be associated with an increased risk of myocardial ischemic events such as angina or myocardial infarction. At this time, FDA has concluded that there isn't enough evidence to indicate that the risks of heart attacks or death are different between Avandia and some other oral type 2 diabetes treatments. People with type 2 diabetes who have underlying heart disease or who are at high risk of heart attack should talk to their healthcare professional about the revised warning as they evaluate treatment options. Healthcare professionals are advised to closely monitor patients who take Avandia for cardiovascular risks.
11-16-07 - MedWatch - The FDA Safety Information and Adverse Event Reporting Program
Thoratec Corporation and FDA notified healthcare professionals and patients of a Class I Recall of Thoratec Implantable Ventricular Assist Devices (IVADs) Driver, serial numbers 488 and higher (located on the label of the sterile package and on the driveline’s Y-connector), manufactured and distributed from October 1, 2004 through October 22, 2007. The device is a mechanical air-driven (pneumatic) pump that helps a person's heart that is too weak to pump blood through the body. The current instructions for use state that IVADs may be implanted or placed in the external position. If the IVAD is placed in the external position, air leaks may develop in the pneumatic driveline that could result in not enough blood flow to and from the heart. This recall does not affect implanted IVADs. Physicians should contact their patients if any Thoratec IVAD was placed in the external position and patients should contact their physicians with any questions.
11-19-07 - MedWatch - The FDA Safety Information and Adverse Event Reporting Program
FDA informed healthcare professionals and consumers of the seizure of 12,682 applicator tubes of Age Intervention Eyelash, sold and distributed by Jan Marini Skin Research, Inc. of San Jose , California . The product was seized because it may lead to decreased vision in some users. The eyelash product is an unapproved and misbranded drug because it is promoted to increase eyelash growth. Before a new drug product may legally be marketed, it must be shown to be safe and effective, and approved by FDA. FDA considers the product to be an adulterated cosmetic because it contains bimatoprost, an active ingredient in an FDA-approved drug to treat elevated intraocular pressure (elevated pressure inside the eye). Use of the prescription drug in addition to the eyelash product containing the drug, may increase the risk of optic nerve damage because the extra dose of bimatoprost may decrease the prescription drug's effectiveness. Damage to the optic nerve may lead to deceased vision and possibly blindness. Other possible adverse events may include macular edema (swelling of the retina) and uveitis (inflammation in the eye) which may lead to decreased vision. Dermatologists, estheticians, and consumers who may still have Age Intervention Eyelash should discontinue use and discard any remaining product. Consumers should also consult their healthcare professional if they have experienced any adverse events that they suspect are related to use of the product.
11-20-07 - MedWatch - The FDA Safety Information and Adverse Event Reporting Program
FDA informed healthcare professionals of reports of suicidal thoughts and aggressive and erratic behavior in patient who have taken Chantix, a smoking cessation product. There are also reports of patients experiencing drowsiness that affected their ability to drive or operate machinery. FDA is currently reviewing these cases, along with other recent reports. A preliminary assessment reveals that many of the cases reflect new-onset of depressed mood, suicidal ideation, and changes in emotion and behavior within days to weeks of initiating Chantix treatment. The role of Chantix in these cases is not clear because smoking cessation, with or without treatment, is associated with nicotine withdrawal symptoms and has also been associated with the exacerbation of underlying psychiatric illness. However, not all patients described in the cases had preexisting psychiatric illness and not all had discontinued smoking.
Healthcare professionals should monitor patients taking Chantix for behavior and mood changes. Patients taking this product should report behavior or mood changes to their doctor and use caution when driving or operating machinery until they know how quitting smoking with Chantix may affect them.
11-26-07 - MedWatch - The FDA Safety Information and Adverse Event Reporting Program
Bodee LLC and FDA notified consumers and healthcare professionals of a nationwide recall of Encore Tablets, a dietary supplement sold in health food stores, via the internet and by mail order nationwide and in Canada. The product was recalled because it contains potentially harmful, undeclared ingredients. One lot of the product contained aminotadalafil, an analog of tadalafil, the active ingredient of a FDA-approved drug used for Erectile Dysfunction. The undeclared chemical poses a threat to consumers because it may interact with nitrates found in some prescription drugs (such as nitroglycerin) and may lower blood pressure to dangerous levels. Consumers who have this product should stop using it immediately and contact their physician if they have experienced any problems that may be related to taking this product.
12-04-07 - MedWatch - The FDA Safety Information and Adverse Event Reporting Program
FDA notified healthcare professionals and patients of the Agency's request that manufacturers update the prescribing information for desmopressin to include important new safety information about severe hyponatremia and seizures. Certain patients, including children treated with the intranasal formulation of the drug for primary nocturnal enuresis (PNE), are at risk for developing severe hyponatremia that can result in seizures and death. As such, desmopressin intranasal formulations are no longer indicated for the treatment of primary nocturnal enuresis and should not be used in hyponatremic patients or patients with a history of hyponatremia. PNE treatment with desmopressin tablets should be interrupted during acute illnesses that may lead to fluid and/or electrolyte imbalance. All desmopressin formulations should be used cautiously in patients at risk for water intoxication with hyponatremia.
FDA provided final recommendations for users of Vail Enclosed Bed Systems that updates the Agency's 2005 Preliminary Public Health Notification. Users of the bed systems were warned that the bed poses a health risk because patients can become entrapped in them and suffocate. Because of the suffocation risk, FDA advises hospitals, nursing homes and consumers who have a Vail enclosed bed system to stop using it and move the patient to an alternate bed. Consumers who are using Vail beds at home should consult with their physicians about other options. See the Public Health Notification for safety precautions recommended by the manufacturer if continued use of the Vail bed is the only option.
12-11-07 - MedWatch - The FDA Safety Information and Adverse Event Reporting Program
FDA informed healthcare professionals of the issuance of the Agency's follow-up communication regarding its review of safety data for the drugs omeprazole and esomeprazole that raised concerns about a potential increased risk of heart problems for patients treated with these drugs. The Agency conducted a comprehensive review of the data from two studies that were submitted to FDA. FDA continues to believe that long-term use of omeprazole or esomeprazole is not likely to be associated with an increased risk of heart problems and recommends that healthcare providers continue to prescribe and patients continue to use these products in the manner described in the labeling for the two products.
12-12-07 - MedWatch - The FDA Safety Information and Adverse Event Reporting Program
FDA informed healthcare professionals that dangerous or even fatal skin reactions (Stevens Johnson syndrome and toxic epidermal necrolysis), that can be caused by carbamazepine therapy, are significantly more common in patients with a particular human leukocyte antigen (HLA) allele, HLA-B*1502. This allele occurs almost exclusively in patients with ancestry across broad areas of Asia , including South Asian Indians. Patients with ancestry from areas in which HLA-B*1502 is present should be screened for the HLA-B*1502 allele before starting treatment with carbamazepine. If these individuals test positive, carbamazepine should not be started unless the expected benefit clearly outweighs the increased risk of serious skin reactions. Patients who have been taking carbamazepine for more than a few months without developing skin reactions are at low risk of these events ever developing from carbamazepine. This is true for patients of any ethnicity or genotype, including patients positive for HLA-B*1502.
FDA alerted healthcare professionals of reports of patient deaths associated with the use of radio frequency (RF) ablation devices during lung tumor ablation. Patient selection, subsequent treatment, and technical use of the RF device, including placement and operation, may have contributed to the fatalities. While RF ablation devices have been cleared for general indications- ablation of soft tissue by thermal coagulation necrosis- the devices have not been cleared specifically for lung tumor ablation. Healthcare professionals should use caution when operating RF ablation devices, adhering strictly to information contained in the labeled operating instructions, Operators Manual, the Manufacturer's Instructions for Use and any training provided. Additionally, if healthcare professionals plan to use RF ablation devices to treat patients with lung tumors, they should consider enrolling patients in an approved clinical study, where training is available.
12-13-07 - MedWatch - The FDA Safety Information and Adverse Event Reporting Program
FDA informed healthcare professionals about serious patient injuries, including third degree burns, associated with the use of poorly maintained electric dental handpieces during dental procedures. Some patients had third degree burns which required plastic surgery. Burns may not be apparent to the operator or the patient until after the tissue damage occurred, because the anesthetized patient cannot feel the tissue burning and the handpiece housing insulates the operator from the heated attachment. Although the reported burns occurred during the cutting of tooth and bone, tooth extraction and other dental surgical procedures, overheating can also occur during any dental procedure. This problem is not limited to dentistry.
12-14-07 - MedWatch - The FDA Safety Information and Adverse Event Reporting Program
Merck & Co. and FDA informed healthcare professionals and consumers of a voluntary recall of eleven lots of PedvaxHIB and two lots of COMVAX vaccines. The vaccines were recalled because the manufacturer cannot assure sterility of the affected lots. Routine testing of the vaccine manufacturing equipment used to produce PedvaxHIB and COMVAX identified the presence of Bacillus cereus bacteria. Sterility tests of the vaccine lots themselves have not found any contamination. The affected doses were distributed in the U.S. starting in April 2007. Healthcare professionals should immediately discontinue use of any of the affected lots and follow the manufacturer's instructions for returning recalled vaccines.
12-18-07 - MedWatch - The FDA Safety Information and Adverse Event Reporting Program
FDA issued a final rule that requires that manufacturers of over-the-counter stand-alone vaginal contraceptive and spermicidal products containing the chemical ingredient nonoxynol 9 (N9) include a warning that the chemical N9 does not provide protection against infection from HIV (the virus that causes AIDS) or other sexually transmitted diseases (STDs). Stand-alone spermicides include gels, foams, films, or inserts containing N9 that are used by themselves for contraception. Additionally, the chemical N9 in stand-alone vaginal contraceptives and spermicides can irritate the vagina and rectum, which may increase the risk of contracting HIV/AIDS from an infected partner. Consumers can protect themselves from the transmission of STDs and HIV by practicing abstinence, being in a monogamous relationship where neither partner is infected, and using condoms consistently and correctly.
12-21-07 - MedWatch - The FDA Safety Information and Adverse Event Reporting Program
FDA issued an update that highlights important information on appropriate prescribing, dose selection, and the safe use of the fentanyl transdermal system (patch). FDA previously issued a Public Health Advisory and Information for Healthcare Professionals in July 2005 regarding the appropriate and safe use of the transdermal system. However, the Agency continues to receive reports of death and life-threatening adverse events related to fentanyl overdose that have occurred when the fentanyl patch was used to treat pain in opioid-naive patients and when opioid-tolerant patients have applied more patches than prescribed, changed the patch too frequently, and exposed the patch to a heat source. The fentanyl patch is only indicated for use in patients with persistent, moderate to severe chronic pain who have been taking a regular, daily, around-the-clock narcotic pain medicine for longer than a week and are considered to be opioid-tolerant. Patients must avoid exposing the patch to excessive heat as this promotes the release of fentanyl from the patch and increases the absorption of fentanyl through the skin which can result in fatal overdose. Directions for prescribing and using the fentanyl patch must be followed exactly to prevent death or other serious side effects from fentanyl overdose.
12-26-07 - MedWatch - The FDA Safety Information and Adverse Event Reporting Program
Cardinal Health notified its customers of a voluntary recall for all Alaris Pump modules, model 8100 (formerly known as Medley Pump module), shipped prior to September 27, 2007. The product is an infusion pump used to dispense various medications. The recall covers Alaris Pump modules that were distributed to 46 States, the District of Columbia , Canada , Guam, Puerto Rico and Saudi Arabia . The pump module was recalled because the unit may contain misassembled occluder springs (bent, broken, nested or missing) that occurred during manufacturing. Misassembled springs could lead to overinfusion that could result in serious adverse health consequences or death. Overinfusion may be difficult to detect because the misassembled springs can work intermittently, and there is no warning or notification of an overinfusion. See the manufacturer's press release for a list of the serial numbers for the devices affected by this recall and how the manufacturer will work with customers to minimize disruption while completing an inspection of the devices.
Bayer Diabetes Care notified healthcare professionals and consumers of a voluntary market recall of test strips (sensors) used exclusively with the Contour TS Blood Glucose Meter. The product was recalled because test strips from specific lots could result in blood glucose readings with a positive bias that could demonstrate 5 - 17% higher test results. This issue is unrelated to the Contour TS meter itself and pertains only to certain test strips used with the meter. There is no impact on the performance of strips with other Bayer meters.
Healthcare professionals, retailers, patients and other customers who use Contour TS are advised to check the lot number of the test strips in their inventory and contact Bayer Diabetes Care for information regarding the return and replacement of strips. See the manufacturer's press release for specific product lot numbers affected by this recall.
AM2 PAT, Inc., and FDA informed healthcare professionals and consumers of a nationwide recall of one lot of Pre-Filled Heparin Lock Flush Solution (5 ml in 12 mL Syringes), Lot # 070926H. The heparin IV flush syringes have been found to be contaminated with Serratia marcescens, which have resulted in patient infections. This type of bacterial infection could present a serious adverse health consequence that could lead to life-threatening injuries and/or death. Consumers and user facilities should stop using the product immediately, quarantine the affected product, and return it to the distributor immediately.
12-31-07 - MedWatch - The FDA Safety Information and Adverse Event Reporting Program
FDA notified consumers and healthcare professionals not to buy or use Super Shangai, Strong Testis, Shangai Ultra, Shangai Ultra X, Lady Shangai, and Shangai Regular (also known as Shangai Chaojimengnan) products. The products are marketed as dietary supplements and used for the treatment of erectile dysfunction (ED) and for sexual enhancement. The products do not qualify as dietary supplements because they contain undeclared active ingredients (sildenafil or an analog of sildenafil) of FDA-approved prescription drugs for ED. The products are thus drugs that are illegal because they lack FDA approval. Additionally, because the manufacturing source of the active ingredients in these products is unknown, consumers should be aware that the safety, efficacy, and purity of the ingredients can not be validated. The undeclared ingredients in the referenced products may interact with nitrates found in some prescription drugs (such as nitroglycerin) and can lower blood pressure to dangerous levels. Consumers with diabetes, high blood pressure, high cholesterol, or heart disease often take products containing nitrates. Consumers who have these products should discontinue using them and consult their healthcare professional.
FDA-MedWatch - The Food and Drug Administration
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