3-16-05 MedWatch - The FDA Safety Information and Adverse Event Reporting Program
FDA and Biogen notified healthcare professionals of revisions to the WARNINGS, PRECAUTIONS/Drug Interactions and ADVERSE REACTIONS/Post-Marketing Experience sections and Medication Guide. Severe hepatic injury, including cases of hepatic failure, has been reported in patients taking Avonex. Asymptomatic elevation of hepatic transaminases has also been reported, and in some patients has recurred upon rechallenge. In some cases, these events have occurred in the presence of other drugs that have been associated with hepatic injury. The potential risk of Avonex used in combination with known hepatotoxic drugs or other products (e.g. alcohol) should be considered prior to Avonex administration, or when adding new agents to the regimen of patients already on Avonex.
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3-17-05 MedWatch - The FDA Safety Information and Adverse Event Reporting Program Eli Lilly and FDA notified healthcare professionals about revisions to the WARNINGS section of labeling for Xigris [drotrecogin alfa (activated)], a biological therapeutic product indicated for the treatment of adult patients with severe sepsis who are at high risk of death. This warning is based upon analyses of two clinical trial databases. Among patients with single organ dysfunction and recent surgery, all-cause mortality was numerically higher in the Xigris group compared to the placebo group. Patients with single organ dysfunction and recent surgery may not be at high risk of death and therefore may not be among the indicated population. Xigris should be used in these patients only after careful consideration of the risks and benefits.
-------------------- 3-21-05 MedWatch - The FDA Safety Information and Adverse Event Reporting Program FDA and PharMEDium Services of Houston notified healthcare professionals of the withdrawal of one lot of PharMEDium Services Magnesium Sulfate 1 gram in 50mL D5W (piggyback) IV solution, which may be contaminated with Serratia marcescens bacteria that can cause serious, life-threatening illness in patients with compromised immune systems. This product is frequently administered intravenously to patients undergoing cardiac surgery and was apparently distributed to several hospitals around the country. To date it has been associated with at least 5 recent cases of Serratia marcescens infection in a hospital in New Jersey. FDA, the U.S. Centers for Disease Control and Prevention, and other public health authorities are investigating this problem to determine if other lots of this product may be affected.
3-21-05 MedWatch - The FDA Safety Information and Adverse Event Reporting Program FDA and HeartSine Technologies, Inc. notified healthcare professionals of a worldwide recall of HeartSine samaritan AED models SAM-001, SAM-002, and SAM-003 with certain serial numbers within the range of 1270 - 2324. These devices may in some cases shut down before delivering a shock, which could result in a delay in treatment or death. This recall was initiated after receipt of several user complaints of shut-down during an attempted charge. HeartSine Technologies, Inc. believes that some of the affected devices could exhibit longer than usual charging rates, causing an alarm and shutdown of the device. Distributors and customers should contact the manufacturer to determine if their product(s) are affected, and arrange to obtain a field upgrade kit as soon as possible.
3-23-05 MedWatch - The FDA Safety Information and Adverse Event Reporting Program FDA and the Department of Justice initiated seizures of all finished Vail 500, 1000, and 2000 Enclosed Bed Systems made by Vail Products, Inc., in a response to ongoing concerns about manufacturing quality and labeling. Use of these systems poses a public health risk because patients can become entrapped and suffocate, resulting in severe neurological damage or death. FDA is aware of approximately 30 entrapments resulting from use of the Vail Enclosed Bed Systems, of which at least 7 resulted in death. FDA advises consumers to stop using Vail 500, 1000 and 2000 Enclosed Bed Systems until they receive additional instructions from Vail Products.
3-24-05 MedWatch - The FDA Safety Information and Adverse Event Reporting Program Wyeth Pharmaceuticals announced that Trecator-SC (ethionamide tablets, USP) Sugar-Coated Tablets have been reformulated to film-coated tablets and renamed Trecator. The new film-coated tablet is more rapidly absorbed, resulting in higher peak concentrations (Cmax) of ethionamide, which may potentially lead to patient intolerance when introduced at the same initial dose as the old sugar-coated tablet. As a result, patients should be monitored and have their dosages re-titrated when switching from the sugar-coated tablet to the film-coated tablet.
3-25-05 MedWatch - The FDA Safety Information and Adverse Event Reporting Program Novartis and FDA notified healthcare professionals of revisions to the DOSAGE AND ADMINISTRATION and WARNINGS sections of the prescribing information to reflect new safety information on management of patients with advanced cancer and renal impairment, whose baseline creatinine clearance is 60 ml/min or lower. The recommended Zometa doses for patients with reduced renal function (mild and moderate renal impairment) are provided in a table. It is recommended that, during treatment, serum creatinine be measured before each dose and treatment should be withheld for renal deterioration.
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3-28-05 MedWatch - The FDA Safety Information and Adverse Event Reporting Program Harmony Brands, Oak Park, Michigan, a national distributor of health, cosmetic and other consumer products, is voluntarily recalling its B-Sure brand One-Step Home Pregnancy Test because its safety and efficacy can no longer be assured. Consumers who have the product in their possession should not use it and should return the product to the point of purchase for a refund. Women who have used the test may wish to contact their health care provider to verify the test results. There have been no reports of failures of the product, and there have been no reports of injury or illness associated with their use. The test was sold throughout the United States in a variety of retail outlets, including Dollar Stores and convenience stores.
4-1-05 MedWatch - The FDA Safety Information and Adverse Event Reporting Program Ortho-McNeil Neurologics modified the PRECAUTIONS section of the Prescribing Information for Reminyl, approved only for the treatment of mild to moderate Alzheimer's Disease. The changes provide new safety information regarding the results of two randomized, placebo-controlled trials of 2 years duration in subjects with mild cognitive impairment(MCI). A total of 13 subjects on REMINYL (n=1026) and 1 subject on placebo (n=1022) died. The deaths were due to various causes which could be expected in an elderly population. About half of the REMINYL deaths appeared to result from various vascular causes (myocardial infarction, stroke), and sudden death.
4-7-05 MedWatch - The FDA Safety Information and Adverse Event Reporting Program After concluding that the overall risk versus benefit profile is unfavorable, FDA has requested Pfizer, Inc. to voluntarily withdraw Bextra (valdecoxib) from the market. This request is based on: * The lack of adequate data on the cardiovascular safety of long-term use of Bextra, along with the increased risk of adverse cardiovascular (CV) events in short-term coronary artery bypass surgery (CABG) trials that FDA believes may be relevant to chronic use. * Reports of serious and potentially life-threatening skin reactions, including deaths, in patients using Bextra. The risk of these reactions in individual patients is unpredictable, occurring in patients with and without a prior history of sulfa allergy, and after both short- and long-term use. * Lack of any demonstrated advantages for Bextra compared with other NSAIDs. Patients currently taking Bextra should contact their physicians to consider alternative treatments. FDA is also asking manufacturers of all marketed prescription NSAIDs, including Celebrex (celecoxib), a COX-2 selective NSAID, to revise the labeling (package insert) for their products to include a boxed warning and a Medication Guide. The boxed warning will highlight the potential for increased risk of CV events with these drugs and the well-described, serious, and potentially life-threatening gastrointestinal (GI) bleeding associated with their use. The Medication Guide will accompany every prescription NSAID at the time it is dispensed to better inform patients about the CV and GI risks. Finally, FDA is asking manufacturers of non-prescription (OTC) NSAIDs to revise their labeling to include more specific information about the potential GI and CV risks, and information to assist consumers in the safe use of the drug. This announcement does not apply to aspirin as it has clearly been shown to reduce the risk of serious adverse CV events in certain patient populations.
4-12-05 MedWatch - The FDA Safety Information and Adverse Event Reporting Program The Food and Drug Administration has issued a public health advisory to alert health care providers, patients, and patient caregivers to new safety information concerning an unapproved, "off-label" use of certain antipsychotic drugs approved for the treatment of schizophrenia and mania. FDA has determined that the treatment of behavioral disorders in elderly patients with dementia with atypical (second generation) antipsychotic medications is associated with increased mortality. Clinical studies of these drugs in this population have shown a higher death rate associated with their use compared to patients receiving a placebo.
4-19-95 MedWatch - The FDA Safety Information and Adverse Event Reporting Program Novartis Pharmaceuticals and FDA notified healthcare professionals about revisions to the WARNINGS and PRECAUTIONS sections of the prescribing information for TRILEPTAL (oxcarbazepine) tablets and oral suspension, indicated for use as monotherapy or adjunctive therapy in the treatment of partial seizures in adults and children ages 4-16 years with epilepsy. The updated WARNINGS section describes serious dermatological reactions, including Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) that have been reported in both children and adults in association with Trileptal use. The PRECAUTIONS section has been updated to include language regarding multi-organ hypersensitivity reactions that have been reported in association with Trileptal use.
4-20-05 MedWatch - The FDA Safety Information and Adverse Event Reporting Program Dade Behring and FDA notified healthcare professionals of a class 1 recall of MicroScan Rapid Pos Inoculum Broth, Lot numbers 050905A-1, 051005A-1, 051605A-1, 051705A-1, 052305B-1, and 052805B-1 used to inoculate MicroScan(r) Rapid Fluorogenic Gram Positive MIC/BP panels, which are intended for the determination of antimicrobial susceptibility of gram-positive organisms. The recall was initiated to prevent health risk to patients due to potential false antibiotic susceptibility results. The possibility of inaccurate susceptibility results for a pathogen could lead a physician to prescribe incorrect or suboptimal therapy.
4-22-05 MedWatch - The FDA Safety Information and Adverse Event Reporting Program Berlex, Inc. reminded healthcare professionals of the prescribing information for Betaseron (interferon beta-1b) as it pertains to hepatic toxicity. Betaseron is approved for the treatment of relapsing forms of multiple sclerosis to reduce the frequency of clinical exacerbations. There have been reports during post-marketing safety surveillance of serious hepatic injury including autoimmune hepatitis and severe liver damage leading to hepatic failure and transplant. Liver function testing is recommended at regular intervals (one, three, and six months) following introduction to Betaseron therapy, and then periodically thereafter in the absence of clinical symptoms.
4-25-05 MedWatch - The FDA Safety Information and Adverse Event Reporting Program Pfizer Inc. and FDA notified healthcare professionals of the voluntary recall of one lot (40,000 bottles) of 100 mg capsules of its epilepsy medication, Neurontin, after a manufacturing mechanical failure resulted in some bottles containing empty or partially filled capsules. Patients taking Neurontin to control epilepsy could experience seizures from a missed dose of the product. 100 mg strength capsules from lot #15224V -- distributed in October and November, 2004 -- are included in the recall. The production lot was distributed only in the United States. No other Neurontin lots were affected.
Eli Lilly and FDA notified healthcare professionals of the stopping of enrollment in a randomized, double-blind, placebo-controlled trial of Xigris in pediatric patients with severe sepsis. Xigris is not indicated for use in pediatric severe sepsis. A planned interim analysis showed that Xigris was highly unlikely to show an improvement over placebo in the primary endpoint of "Composite Time to Complete Organ Failure Resolution" over 14 days. A numerical increase in the rate of central nervous system (CNS) bleeding in the Xigris versus the placebo group was also noted. Over the infusion period the number of patients experiencing an intracranial hemorrhage event was 4 versus 1 for the overall population (Xigris vs. placebo), with 3 of the 4 events in the Xigris group occurring in patients aged 60 days or less.
4-28-05 MedWatch - The FDA Safety Information and Adverse Event Reporting Program Kingswood Laboratories, Inc and FDA notified healthcare professionals of a nationwide recall of Moi-Stir Oral swabsticks due to the finding that certain lots contain molds including Aspergillus and Penicillium which could result in respiratory infections. The swabsticks contain a saliva supplement intended to relieve dry mouth, physically clean the oral cavity, thin phlegm, and lower dental caries rates. The product was distributed to hospitals, hospital wholesalers, pharmacies, nursing homes, physician and dentist offices, consumers, some government medical facilities, and as free samples to a small number of individuals. Doctors and dentists should consider screening patients who are at risk for infections, especially those with weakened immune systems (low white blood cell counts) who have used the Moi-Stir Swabstick.
4-29-05 MedWatch - The FDA Safety Information and Adverse Event Reporting Program Bedford Laboratories and FDA notified healthcare professionals of the voluntary recall of one lot of Famotidine Injection, 20 mg/2 mL (NDC 55390-029-10), Lot# 609336, exp. 04/06, due to a lack of sterility assurance. This prescription product was distributed in August 2004 throughout the United States to wholesalers and distributors, who further distributed the product to hospitals.
5-2-05 MedWatch - The FDA Safety Information and Adverse Event Reporting Program Laerdal Medical Corporation and FDA notified healthcare professionals of a voluntary recall of all lots of CM 100-Heartstart Adapter Cable, Cat. No. 920650 (Adapter Cable). Wires within the defibrillator adapter cables are susceptible to breakage that prevented delivery of defibrillation shocks. The test method described in the defibrillator instructions for use will not detect internal breaks in the adapter cables. Use of these Adapter Cables should be discontinued.
5-10-05 MedWatch - The FDA Safety Information and Adverse Event Reporting Program FDA notified healthcare professionals that serious injury or death can occur when patients with implanted neurological stimulators undergo MRI procedures. The FDA received several reports of serious injury, including coma and permanent neurological impairment. The mechanism for these adverse events is likely to involve heating of the electrodes at the end of the leadwires, resulting in injury to the surrounding tissue. The public health notification also offered recommendations for preventive actions.
5-11-05 MedWatch - The FDA Safety Information and Adverse Event Reporting Program The FDA warned the public about the sale of counterfeit versions of Lipitor, Viagra, and an unapproved product promoted as "generic Evista" to U.S. consumers at pharmacies in Mexican border towns. The "generic Evista" was analyzed by FDA in coordination with the National Association of Boards of Pharmacy and was found to contain no active ingredient. The counterfeit Lipitor and counterfeit Viagra were analyzed by Pfizer, Inc. and were also found to contain no active ingredient. Consumers who have any of these counterfeit products should not use them and should contact their healthcare provider immediately.
5-11-05 MedWatch - The FDA Safety Information and Adverse Event Reporting Program LifeScan, Inc, initiated a worldwide notification to all users of its OneTouch Ultra, InDuo and OneTouch FastTake Meters. LifeScan found that it was possible for consumers, in the course of setting their meter's date and time, to accidentally change the unit of measure and thereby misinterpret their blood glucose results. The notification program includes letters to registered users and health care professionals, and also special instructions inserted in each package of test strips. The products are distributed worldwide primarily through retail pharmacy and mail order channels.
5-12-05 MedWatch - The FDA Safety Information and Adverse Event Reporting Program MRL Inc. and FDA notified healthcare professionals of a voluntary worldwide recall of 597 AED20 Automatic External Defibrillators manufactured between February and July of 2004. The AED20 may display a "Defib Comm" error message during use resulting in a failure of the device to analyze the patient's ECG and deliver the appropriate therapy which prevents the defibrillator from resuscitating a patient. The company has received 12 related complaints with this specific group of AED20's, including one instance which may have prevented patient resuscitation.
5-18-05 MedWatch - The FDA Safety Information and Adverse Event Reporting Program BioMerieux and FDA notified healthcare professionals of a class 1 recall of MDA Simplastin HTF (human thromboplastin factor) tissue reagent, a tissue thromboplastin reagent used in determination of the prothrombin time (PT) in human plasma. The prothrombin time (PT) laboratory test is used to control the use of oral anticoagulant therapy, (i.e. Coumadin) in patients with bleeding disorders. Mislabeling problems with certain lots of this product could result in inaccurate test results, which in turn could lead to improper patient treatment - in some cases resulting in serious or life-threatening injury. Although BioMerieux initiated a recall of these products in March 2005, its notifications to purchasers incorrectly indicated that the problem was of no clinical significance. The company is now clearly informing its customers about the importance of this problem and the need to respond to it. Laboratories that have this reagent should not use it, but instead contact the company. Laboratories that have used this reagent should also contact any physicians or medical institutions whose patients may be affected by this problem.
5-18-05 MedWatch - The FDA Safety Information and Adverse Event Reporting Program Novartis and FDA notified dental healthcare professionals of revisions to the prescribing information to describe the occurence of osteonecrosis of the jaw (ONJ) observed in cancer patients receiving treatment with intravenous bisphosphonates, Aredia (pamidronate disodium) and Zometa (zoledronic acid). The prescribing information recommends that cancer patients receive a dental examination prior to initiating therapy with intravenous bisphosphonates (Aredia and Zometa), and avoid invasive dental procedures while receiving bisphosphonate treatment. For patients who develop ONJ while on bisphosphonate therapy, dental surgery may exacerbate the condition.
5-20-05 MedWatch - The FDA Safety Information and Adverse Event Reporting Program The Master's Miracle (TMM) company of Minneapolis, Minn., and FDA alerted the public against applying the company's TMM brand Fortified Mineral Neutralizer and Ultra Fortified Mineral Neutralizer to the eyes because these products may be contaminated with Pseudomonas aeruginosa, Pseudomonas flourescens/putida and Enterobacter cloacae -- bacteria that, if applied to the eyes, might lead to serious injury, including possible blindness. The products are labeled as a Dietary Supplement and distributed nationwide in 8 oz., 20 oz. and one-gallon size containers.
Serono and FDA notified healthcare professionals of revisions to the BOXED WARNING, WARNINGS, and DOSAGE AND ADMINISTRATION sections of the prescribing information for Novantrone [mitoxantrone], indicated for treatment of multiple sclerosis (MS). The Dear Healthcare Professional letter provides additional information concerning the risks of cardiotoxicity associated with Novantrone and also provides supplemental information regarding secondary acute myelogenous leukemia (AML) reported in MS patients treated with Novantrone.
6-01-05 MedWatch - The FDA Safety Information and Adverse Event Reporting Program The Food and Drug Administration notified consumers and healthcare professionals of a nationwide recall of all manufactured drugs (mostly generic prescription drugs, including drugs containing acetaminophen) from Able Laboratories of Cranbury, NJ, because of serious concerns that they were not produced according to quality assurance standards. Able Laboratories has ceased all current production. FDA recommends that people who have been taking drugs produced by this firm speak with their health care provider or pharmacist to obtain a replacement drug product. Consumers should continue taking the medication until they have spoken with their health care provider. FDA has provided a list with the names of the recalled drugs and their imprint codes, marks (usually letters and numbers) found on the surfaces of drugs.
6-03-05 MedWatch - The FDA Safety Information and Adverse Event Reporting Program McNeil Specialty Pharmaceuticals and FDA notified consumers and healthcare professionals about a nationwide recall of all lots and all flavors of Children's TYLENOL Meltaways 80 mg, Children's TYLENOL SoftChews 80mg, and Junior TYLENOL Meltaways 160mg. The recall addresses issues regarding the design of the blister package, information on the package, and bottle cartons for the products that may be confusing and lead to improper dosing, including overdosing. Read the complete MedWatch 2005 Safety summary, including a link to the firm press release, at:
6-10-05 MedWatch - The FDA Safety Information and Adverse Event Reporting Program Bristol-Myers Squibb and FDA notified healthcare professionals of revisions to the WARNINGS, PRECAUTIONS/Pregnancy and Information for Patients, and PATIENT INFORMATION sections of the prescribing information for Sustiva (efavirenz), indicated in the treatment of HIV-1 infection. The revisions are a result of four retrospective reports of neural tube defects in infants born to women with first trimester exposure to Sustiva, including three cases of meningomyelocele and one Dandy Walker Syndrome. As Sustiva may cause fetal harm when administered during the first trimester to a pregnant woman, pregnancy should be avoided in women receiving Sustiva. An antiretroviral pregnancy registry has been established to monitor fetal outcomes of pregnant women exposed to Sustiva.
6-15-05 MedWatch - The FDA Safety Information and Adverse Event Reporting Program FDA has requested that sponsors of all non-steroidal anti-inflammatory drugs (NSAID) make labeling changes to their products. FDA recommended proposed labeling for both the prescription and over-the-counter (OTC) NSAIDs and a medication guide for the entire class of prescription products. All sponsors of marketed prescription NSAIDs, including Celebrex (celecoxib), a COX-2 selective NSAID, have been asked to revise the labeling (package insert) for their products to include a boxed warning, highlighting the potential for increased risk of cardiovascular (CV) events and the well described, serious, potential life-threatening gastrointestinal (GI) bleeding associated with their use. FDA regulation 21CFR 208 requires a Medication Guide to be provided with each prescription that is dispensed for products that FDA determines pose a serious and significant public health concern.
6-16-05 MedWatch - The FDA Safety Information and Adverse Event Reporting Program Qualitest Pharmaceuticals and FDA notified healthcare professionals and consumers of a voluntary nationwide recall of AccuSure Insulin Syringes 1cc, 28 Gauge 1/2 Inch, distributed between October 2004 and June 2005. There may be 1cc syringes which are mislabeled as 1/2 cc syringes on the plastic inner wrap holding 10 individual syringes, which could potentially result in confusion by the patient or caregiver, resulting in an incorrect dose or amount being administered.
6-16-05 MedWatch - The FDA Safety Information and Adverse Event Reporting Program Quality Care Products, LLC, a federally licensed drug re-packager, and FDA notified healthcare professionals of a nationwide recall of any and all numbers repackaged from drugs that were manufactured by Able Laboratories Inc. This recall is due to Able Laboratories voluntary recall of all of their drug products because of the FDA's serious concerns that they were not produced according to quality assurance standards.
AstraZeneca and FDA notified healthcare professionals of new approved labeling for Iressa that states the medicine should be used only in cancer patients who have already taken the medicine and whose doctor believes it is helping them. New patients should not be given Iressa because in a large study Iressa did not make people live longer. There are other medicines for non-small cell lung cancer (NSCLC) that have shown an ability to make people live longer.
6-21-05 MedWatch - The FDA Safety Information and Adverse Event Reporting Program FDA and Guidant Corporation notified health care providers and patients of the recall of certain implantable defibrillators and cardiac resynchronization therapy defibrillators. These devices, surgically implanted in persons who have a type of heart disease that creates the risk of a life-threatening heart arrhythmia (abnormal rhythm), can develop an internal short circuit without warning, resulting in the devices' inability to deliver an electrical shock during episodes of arrhythmia -- which could lead to a serious, life-threatening event. There have been two deaths reported to FDA suspected to be associated with this malfunction. The devices affected by this notification are: PRIZM 2 DR, Model 1861, manufactured on or before April 16, 2002 CONTAK RENEWAL, Model H135, manufactured on or before August 26, 2004 CONTAK RENEWAL 2, Model H155, manufactured on or before August 26, 2004
6-24-05 MedWatch - The FDA Safety Information and Adverse Event Reporting Program Vail Products is permanently ceasing the manufacture, sale and distribution of all Vail enclosed bed systems, and will no longer be available to provide accessories, replacement parts, or retrofit kits. On June 23 and 24, 2005, revised instruction manuals and warning labels were mailed to customers with Vail 500, Vail 1000 or Vail 2000 enclosed bed systems. The revised manuals include new warnings, precautions, and instructions for use. FDA is advising 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 can consult with their physicians about other options.
6-28-05 MedWatch - The FDA Safety Information and Adverse Event Reporting Program Boston Scientific and FDA notified healthcare professionals of a recall of all Hemashield VANTAGE vascular grafts manufactured in the last two years due to the potential for the device, used in peripheral procedures, to fray or tear during suturing and lead to post-operative complications. Boston Scientific is aware of three reported post-operative failures which occurred between three and seven days post-procedure. In all of these cases, the patients were successfully treated by re-suturing the graft or replacing it.
7-01-05 MedWatch - The FDA Safety Information and Adverse Event Reporting Program In response to recent scientific publications that report the possibility of increased risk of suicidal behavior in adults treated with antidepressants, the FDA has issued a Public Health Advisory to update patients and healthcare providers with the latest information on this subject. Even before the publication of these recent reports, FDA had already begun the process of reviewing available data to determine whether there is an increased risk of suicidal behavior in adults taking antidepressants. The Agency has asked manufacturers to provide information from their trials using an approach similar to that used in the evaluation of the risk of suicidal behavior in the pediatric population taking antidepressants. This effort will involve hundreds of clinical trials and may take more than a year to complete.
7-05-05 MedWatch - The FDA Safety Information and Adverse Event Reporting Program FDA notified consumers and healthcare professionals about the risks of taking Liqiang 4 Dietary Supplement Capsules because they contain glyburide - a drug that could have serious, life-threatening consequences in some people. The product is manufactured by Liqiang Research Institute, China, and marketed throughout the United States in herbal stores and through mail order by Bugle International of Northridge CA. Glyburide is a drug used to lower blood sugar, and is safe and effective when used as labeled in FDA-approved medications. People who have low blood sugar or those with diabetes can receive dangerously high amounts of glyburide by consuming Liqiang 4. Consumers should immediately stop using these products and seek medical attention, especially if they are currently being treated with diabetes drugs or if they have symptoms of fatigue, excessive hunger, profuse sweating, or numbness of the extremities.
7-08-05 MedWatch - The FDA Safety Information and Adverse Event Reporting Program FDA notified healthcare professionals of updated labeling for Cialis, Levitra and Viagra to reflect a small number of post-marketing reports of sudden vision loss, attributed to NAION (non arteritic ischemic optic neuropathy), a condition where blood flow is blocked to the optic nerve. FDA advises patients to stop taking these medicines, and call a doctor or healthcare provider right away if they experience sudden or decreased vision loss in one or both eyes. Patients taking or considering taking these products should inform their health care professionals if they have ever had severe loss of vision, which might reflect a prior episode of NAION. Such patients are at an increased risk of developing NAION again. At this time, it is not possible to determine whether these oral medicines for erectile dysfunction were the cause of the loss of eyesight or whether the problem is related to other factors such as high blood pressure or diabetes, or to a combination of these problems. Read the complete MedWatch 2005 Safety summary, including links to the new labeling information and additional information for healthcare providers and consumers at:
7-08-05 MedWatch - The FDA Safety Information and Adverse Event Reporting Program Janssen and FDA notified healthcare professionals of changes to the BOXED WARNING/WARNINGS,CONTRAINDICATIONS,PRECAUTIONS, and DOSAGE AND ADMINISTRATION sections of the prescribing information for Duragesic. These changes include important safety information in the following areas of the labeling: Use Only in Opioid-Tolerant Patients, Misuse, Abuse and Diversion, Hypoventilation (Respiratory Depression), Interactions with CYP3A4 Inhibitors, Damaged or Cut Patches, Accidental Exposure to Fentanyl, Chronic Pulmonary Disease, Head Injuries and Intracranial Pressure, Interactions with Other CNS Depressants, and Interactions with Alcohol and Drugs of Abuse.
7-14-05 MedWatch - The FDA Safety Information and Adverse Event Reporting Program FDA issued a public health advisory to notify health care professionals and consumers that the sponsor of Palladone, Purdue Pharma, has agreed to suspend sales and marketing of Palladone (hydromorphone hydrochloride, extended release capsules), a potent narcotic painkiller, because of the potential for severe side effects if Palladone is taken with alcohol. Drinking alcohol while taking Palladone may cause rapid release of hydromorphone, leading to high drug levels in the body, with potentially fatal effects. High drug levels of hydromorphone may depress or stop breathing, cause coma, and even cause death.
7-15-05 MedWatch - The FDA Safety Information and Adverse Event Reporting Program FDA issued a public health advisory to alert health care professionals, patients and their caregivers of reports of death and other serious side effects from overdoses of fentanyl in patients using fentanyl transdermal (skin) patches for pain control. Deaths and overdoses have occurred in patients using both the brand name product Duragesic and the generic product. Some patients and health care providers may not be fully aware of the dangers of this very strong narcotic painkiller. The directions for using the fentanyl skin patch must be followed exactly to prevent death or other serious side effects from overdosing with fentanyl.
7-18-05 MedWatch - The FDA Safety Information and Adverse Event Reporting Program FDA issued a Preliminary Public Health Notification and Advice for Patients for Guidant VENTAK PRIZM 2 DR and CONTAK RENEWAL Implantable Cardioverter Defibrillators to provide clinicians with current information and guidance concerning malfunctions occurring with these devices, which were the subjects of a Class I recall announced by FDA on July 1, 2005. The malfunction that is the subject of the recall causes damage to the device's circuitry, potentially resulting in the inability to deliver the required shock during episodes of arrhythmia. This malfunction could lead to a serious, life-threatening event. Importantly, the device does not give any sign of impending failure, and there is no test that predicts whether any particular device will fail. The affected devices are: VENTAK PRIZM 2 DR, Model 1861, manufactured on or before April 16, 2002 CONTAK RENEWAL, Model H135, manufactured on or before August 26, 2004 CONTAK RENEWAL 2, Model H155, manufactured on or before August 26, 2004
7-19-05 MedWatch - The FDA Safety Information and Adverse Event Reporting Program Guidant notified physicians and patients of new safety information for certain models of cardiac pacemakers manufactured between November 25, 1997 and October 26, 2000. A hermetic sealing component used in these devices may experience a gradual degradation, resulting in a higher than normal moisture content within the pacemaker case late in the device's service life. The clinical behaviors associated with this failure mode can result in serious health complications. Guidant has confirmed twenty reports of loss of pacing output associated with this failure mode, including five patients experiencing syncope. Loss of pacing output has also been associated with reports of presyncope requiring hospitalization. Guidant has received two reports of sustained Maximum Sensor Rate ("MSR") pacing in which heart failure may have developed in association with sustained high rate pacing. Physicians should consider the unique needs of individual patients and the specific technical recommendations set forth in the July 18, 2005 physician communication. Guidant recommends that physicians consider replacing devices for pacemaker-dependent patients and advises patients to seek medical attention immediately if they notice shortness of breath, dizziness, lightheadedness or a prolonged fast heart rate.
7-20-05 MedWatch - The FDA Safety Information and Adverse Event Reporting Program Danco Laboratories and FDA have revised the BOXED WARNING and WARNINGS sections of the Prescribing Information, the Medication Guide and Patient Agreement to inform healthcare professionals of four cases of septic deaths in the United States, all reported from California, from September 2003 to June 2005 in women following medical abortion with mifepristone (Mifeprex) and misoprostol. The bacteria causing sepsis has been identified in two of the cases as Clostridium sordellii. The two confirmed cases of Clostridium sordellii did not have the usual signs and symptoms of an infection. All providers of medical abortion and their patients need to be aware of the risks of sepsis.
7-20-05 MedWatch - The FDA Safety Information and Adverse Event Reporting Program Genentech and FDA revised the WARNINGS, ADVERSE REACTIONS sections and Patient Information Sheet for RAPTIVA (efalizumab), indicated for the treatment of adult patients (18 years or older) with chronic moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy. Healthcare professionals and patients were informed about reports of immune-mediated hemolytic anemia and warnings regarding postmarketing reports of thrombocytopenia and serious infections including necrotizing fasciitis, tuberculous pneumonia, bacterial sepsis with seeding of distant sites, severe pneumonia with neutropenia, and worsening of infection (e.g. cellulitis, pneumonia) despite antimicrobial treatment.
7-21-05 MedWatch - The FDA Safety Information and Adverse Event Reporting Program Baxter Healthcare Corporation and FDA notified healthcare professionals of a Class I recall of all models of its Colleague Volumetric Infusion Pumps because they can shut down while delivering critical medication and fluids to patients. Baxter has received six reports of serious injury and three reports of death associated with this shut-down problem. The affected are: Models 2M8151, 2M8151R, 2M8161, 2M8161R, 2M8153, 2M8153R, 2M8163, 2M8163R. In addition to the shut-down problem, the device may exhibit two additional failure modes: 1) Users may inadvertently press the on/off key instead of the start key when attempting to start an infusion; 2) Disconnecting or connecting the pump from the hospital monitoring system while the pump is powered "on" can result in a failure code, requiring the infusion to be restarted. These failures may occur during the infusion of therapy, so it is imperative that health care institutions have a contingency plan to mitigate any disruptions of infusions of life-sustaining drugs or fluids. Approximately 255,000 Colleague Volumetric Infusion Pumps are currently in use, including 206,000 distributed in the United States.
7-29-05 Guidant notified healthcare professionals in an update letter issued July 22 that one of the safety recommendations made to physicians on June 17 regarding its VENTAK PRIZM, VITALITY, and CONTAK RENEWAL AVT implantable cardioverter defibrillators (ICDs) may significantly increase the risk to patients. Physicians are advised to schedule follow-up visits as soon as possible for patients with devices reprogrammed as per original instructions and for all patients with Atrial Episode Data Storage programmed to less than 20%.
8-01-05 MedWatch - The FDA Safety Information and Adverse Event Reporting Program Disetronic Medical Systems and FDA notified healthcare professionals and patients about a nationwide recall of D-TRON adapters, used with the D-TRONplus insulin pump, because they can potentially over-deliver a maximum amount of up to 1.8 I.U. of insulin. Use of these recalled adapters may pose a potential life-threatening situation to certain children using the pump. Other users who are insulin sensitive may also be at increased risk.
8-02-05 MedWatch - The FDA Safety Information and Adverse Event Reporting Program FDA alerted U.S. residents to the recent recall of a batch of counterfeit "Lipitor" (atorvastatin) sold in the United Kingdom (U.K.). The medicine is used to treat high cholesterol. The counterfeit Lipitor 20mg tablets were recalled in the U.K. on July 28, 2005. Health authorities in the U.K. stated that initial results of tests performed on the counterfeit drugs do not indicate that this product poses an immediate risk to patients. Some U.S. residents may have obtained prescription drugs from the U.K. through on-line or storefront operations that do not supply legitimate, FDA-approved products, or through state-run drug importation programs that facilitate the purchase of unapproved foreign drugs. Consumers who purchase drugs through these arrangements may have received these counterfeit products. U.S. patients who have the identified U.K. drugs should stop using them and should consult their physician or pharmacist if they have any questions or concerns.
8-03-05 MedWatch - The FDA Safety Information and Adverse Event Reporting Program FDA issued a Public Health Notification to alert healthcare professionals to serious complications associated with the use of metallic tracheal stents in patients with benign airway disorders, and to recommend specific actions to prevent or minimize the problem. This notification includes all covered and uncovered metallic tracheal stents. These complications include obstructive granulation tissue, stenosis at the ends of the stent, migration of the stent, mucous plugging, infection, and stent fracture. This notification focuses on patients with benign airway disorders because use of metallic stents in this patient population may preclude them from receiving future alternative therapies (such as tracheal surgical procedures or placement of silicone stents) after a metallic stent is removed.
8-03-05 MedWatch - The FDA Safety Information and Adverse Event Reporting Program Perrigo and FDA notified healthcare professionals and consumers of the recall of all lots of concentrated infants' drops that are packaged with a dosing syringe bearing only a "1.6 mL" mark containing 1] acetaminophen,2] acetaminophen, dextromethorphan HBr, and pseudoephedrine HCl, or 3] dextromethorphan HBr, and pseudoephedrine HCl. The dosing syringe may be confusing in determining the proper dose for infants under 2 years of age as directed by a doctor and could lead to improper dosing, including overdosing. The following products are being recalled: * Cherry Flavor Infant Pain Reliever 160 mg Acetaminophen (0.5oz. and 1.0oz) * Grape Flavor Infant Pain Reliever 160 mg Acetaminophen (0.5oz. and 1.0oz) * Cherry Flavor Cough and Cold Infant Drops (0.5oz) * Cherry Flavor Decongestant and Cough Infant Drops (0.5oz) Read the complete MedWatch 2005 Safety summary, including a link to the FDA Talk Paper and the firm press release, at:
8-12-05 MedWatch - The FDA Safety Information and Adverse Event Reporting Program FDA notified healthcare professionals and patients of the approval of a strengthened risk management program, called iPLEDGE, for Accutane and generic isotretinoin. The strengthened program requires registration of wholesalers, prescribers, pharmacies and patients who agree to accept specific responsibilities designed to minimize pregnancy exposures in order to distribute, prescribe, dispense and use Accutane. In addition to approving the iPLEDGE program, FDA has approved changes to the existing warnings, patient information and informed consent document so that patients and prescribers can better identify and manage the risks of psychiatric symptoms and depression before and after prescribing isotretinoin. Read the complete MedWatch 2005 Safety Summary, including a link to the FDA Public Health Advisory and Press Release, FDA Drug Information Page, Healthcare Professional Information Sheet, FDA Patient Information Sheet, and the approved product labeling:
8-19-05 MedWatch - The FDA Safety Information and Adverse Event Reporting Program Gambro Dasco S.p.A notified healthcare professionals and consumers of a safety alert for the Prisma continuous renal replacement system (all catalog numbers). Gambro Dasco has become aware of several serious injuries and deaths resulting from excessive ultrafiltration (fluid being removed from the patient's body). This problem can occur when the user does not address the cause of the "Incorrect Weight Change Detected" alarm. This alarm should never be overridden without first identifying and removing the cause of the alarm. The device remains appropriate for use when these directions are followed.
8-29-05 MedWatch - The FDA Safety Information and Adverse Event Reporting Program Custom RX Compounding Pharmacy and FDA notified ophthalmologists, other healthcare professionals, and consumers about a nationwide recall of Trypan Blue 0.06% Ophthalmic Solution, intended for use in the eyes during cataract surgery, because it may be contaminated with Pseudomonas aeruginosa, a bacteria that, if applied to the eyes, might lead to serious injury, including possible blindness. Custom Rx Pharmacy is asking that all unexpired syringes be collected and returned to the pharmacy. The product was distributed to hospitals and clinics in Maryland, Minnesota, Illinois, Nebraska, North Dakota, Michigan, the District of Columbia, and Pennsylvania. The recall includes, but may not be limited to the following lot numbers: 05042005:86@17, 05252005:36@13, 06282005:91@27, 08012005:63@24, and 08182005:43@17.
8-29-05 MedWatch - The FDA Safety Information and Adverse Event Reporting Program Medline and FDA notified healthcare professionals about a nationwide recall of Alcohol-Free Mouthwash and Hygiene Kits containing mouthwash because of potential contamination with Burkholderia cepacia. People who have certain health problems such as weakened immune systems or chronic lung diseases, particularly cystic fibrosis (CF), may be more susceptible to infections with B. cepacia. The product was distributed to hospitals, medical centers, and long term care facilities nationwide. There is no known distribution through retail sales. The CDC has confirmed hospital illness associated with the use of the affected mouthwash in Texas and Florida.
8-31-05 MedWatch - The FDA Safety Information and Adverse Event Reporting Program Genentech and FDA notified healthcare professionals of updated cardiotoxicity information related to the use of Herceptin (trastuzumab), obtained from the National Surgical Adjuvant Breast and Bowel Project (NSABP) study (B-31), a randomized, Phase III trial that was conducted in 2043 women with operable, HER2 overexpressing breast cancer (IHC 3+ or FISH+). This study demonstrated a significant increase in cardiotoxicity in patients who were randomized to the Herceptin-containing arm as compared to patients who received chemotherapy alone. Preliminary analysis of safety data from Study NSABP B-31 and the North Central Cancer Treatment Group (NCCTG) study (N9831) revealed a statistically significant increase in the 3-year cumulative incidence of New York Heart Association Class III and IV congestive heart failure and cardiac death observed in patients who received the Herceptin-containing regimen (4.1%) compared with control (0.8%). There were no cardiac deaths observed in patients who received the Herceptin-containing regimen and one cardiac death was observed in the control arm. Final analysis of the cardiac safety data collected in Studies NSABP B-31 and NCCTG N9831 is ongoing.
9-16-05 MedWatch - The FDA Safety Information and Adverse Event Reporting Program BioMerieux and FDA notified healthcare professionals of a recall of VeriCal Calibrator Set, used to calibrate the Prothrombin Time (PT) and Activated Partial Thromboplastin Times (APTT) on bioMerieux instrument platforms. This recall only impacts INR determinations derived from Prothrombin Tim (PT) results on the following instrument platforms: MDA Coag-A-Mate MTX and Coag-A-Mate MAX. The recall is due to the mis-assignment of ISI values associated with VeriCal use. These calibrated ISI values are currently provided on Simplastin HFT and Simplastin L product labeling. The VeriCal labeling currently contains PT time in seconds and is being revised to include ISI assignment for specified reagents. The product recall notice offers detailed recommendations for action by laboratory personnel using these products.
9-17-05 MedWatch - The FDA Safety Information and Adverse Event Reporting Program FDA is notifying healthcare professionals and hospitals about a product recall involving all injectable products manufactured by Central Admixture Pharmacy Services, Inc. of Lanham, Maryland ("CAPS") due to concerns regarding the sterility of these injectable products. CAPS distributed the affected injectable products to hospitals in Maryland, Delaware, Washington, D.C., and Virginia. Gram negative rods have been identified in two lots of Cardioplegia solution manufactured by CAPS. Non-sterility of injectable products could represent a serious hazard to health that could lead to life-threatening injuries and death.
9-27-05 MedWatch - The FDA Safety Information and Adverse Event Reporting Program AstraZeneca and FDA notified healthcare professionals reports of medication dispensing or prescribing errors between Toprol-XL (metoprolol succinate) extended release tablets, indicated for the treatment of hypertension, long-term treatment of angina pectoris, and heart failure NYHA Class II or III, and Topamax (topiramate), a product of Ortho-McNeil Neurologics, Inc, indicated for the treatment of epilepsy and migraine prophylaxis. There have also been reports of medication errors involving confusion between Toprol-XL and Tegretol or Tegretol-XR (carbamazepine), products of Novartis Pharmaceuticals Corporation, indicated for the treatment of complex partial seizures, generalized tonic-clonic seizures, and trigeminal neuralgia. These reports include instances where Toprol-XL was incorrectly administered to patients instead of Topamax, Tegretol, or Tegretol-XR, and vice versa, some of them leading to adverse events.
9-27-05 MedWatch - The FDA Safety Information and Adverse Event Reporting Program GlaxoSmithKline (GSK) and FDA notified healthcare professionals of changes to the Pregnancy/PRECAUTIONS section of the Prescribing Information for Paxil and Paxil CR Controlled-Release Tablets to describe the results of a GSK retrospective epidemiologic study of major congenital malformations in infants born to women taking antidepressants during the first trimester of pregnancy. This study suggested an increase in the risk of overall major congenital malformations for paroxetine as compared to other antidepressants [OR 2.2; 95% confidence interval, 1.34-3.63]. Healthcare professionals are advised to carefully weigh the potential risks and benefits of using paroxetine therapy in women during pregnancy and to discuss these findings as well as treatment alternatives with their patients.
9-27-05 MedWatch - The FDA Safety Information and Adverse Event Reporting Program
American Pharmaceutical Partners, Inc. and FDA notified healthcare professionals about a nationwide recall of Fluorouracil Injection 50 mg/mL
(500 mg/10 mL Single Dose Vial) because of the potential for invisible glass particles containing silica and aluminum in vials of the product. The company states that only Product code 101710 is susceptible to this type of glass breakdown.
9-29-05 MedWatch - The FDA Safety Information and Adverse Event Reporting Program The FDA directed Eli Lilly and Company (Lilly), the manufacturer of Strattera (atomoxetine), to revise the prescribing information to include a boxed warning and additional warning statements that alert health care providers of an increased risk of suicidal thinking in children and adolescents being treated with this medication. FDA also informed Lilly that a Patient Medication Guide (MedGuide) should be provided to patients when Strattera is dispensed. The MedGuide advises patients of the risks associated with and precautions that can be taken when Strattera is dispensed. Further, pediatric patients being treated with Strattera should be closely observed for clinical worsening, as well as agitation, irritability, suicidal thinking or behaviors, and unusual changes in behavior, especially during the initial few months of a course of drug therapy, or at times of dose changes, either increases or decreases.
10-03-05 MedWatch - The FDA Safety Information and Adverse Event Reporting Program FDA and CDC notified consumers and health care providers of five reports of Guillain Barre Syndrome following administration of Meningococcal Conjugate Vaccine A, C, Y, and W135 (trade name Menactra), manufactured by Sanofi Pasteur. It is not known yet whether these cases were caused by the vaccine or are coincidental. FDA and CDC are sharing this information with the public now and actively investigating the situation because of its potentially serious nature. Guillain Barre Syndrome (GBS) is a serious neurological disorder that can occur, often in healthy individuals, either spontaneously or after certain infections. GBS typically causes increasing weakness in the legs and arms that can be severe and require hospitalization. Because of the potentially serious nature of this matter, FDA and CDC are asking any persons with knowledge of any possible cases of GBS occurring after Menactra to report them to the Vaccine Adverse Event Reporting System <https://secure.vaers.org/VaersDataEntryintro.htm> (VAERS) to help the agencies further evaluate the matter.
10-17-05 MedWatch - The FDA Safety Information and Adverse Event Reporting Program FDA and Boston Scientific notified healthcare professionals and patients about serious adverse events, including death, occurring in patients treated with ENTERYX, a liquid chemical polymer which is intended to be injected into the lower esophageal sphincter for treatment of gastroesophageal reflux disease. The serious adverse events involve unrecognized transmural injections of ENTERYX(r) into structures surrounding the esophagus. On September 23, 2005, Boston Scientific issued a recall of all ENTERYX Procedure Kits and ENTERYX Injector Single Packs from commercial distribution.
10-17-05 MedWatch - The FDA Safety Information and Adverse Event Reporting Program Eli Lilly and FDA notified healthcare professionals of revision to the PRECAUTIONS/Hepatotoxicity section of the prescribing information for Cymbalta (duloxetine hydrochloride), indicated for treatment of major depressive disorder and diabetic peripheral neuropathic pain. Postmarketing reports of hepatic injury (including hepatitis and cholestatic jaundice) suggest that patients with preexisting liver disease who take duloxetine may have an increased risk for further liver damage. The new labeling extends the Precaution against using Cymbalta in patients with substantial alcohol use to include those patients with chronic liver disease. It is recommended that Cymbalta not be administered to patients with any hepatic insufficiency.
10-27-05 MedWatch - The FDA Safety Information and Adverse Event Reporting Program FDA notified health care providers and patients of a problem with blood glucose meters made by Abbott Diabetes Care, Alameda, Calif. The meters can unintentionally be switched from one unit of measurement to another, resulting in an inaccurate blood glucose interpretation by the user. Users in the United States should make sure that their meter reading is displayed as mg/dL because an inaccurate reading can lead to taking the wrong dose of insulin or dietary changes, resulting in higher levels of sugar in the blood or hyperglycemia. Hyperglycemia can be a serious and even life-threatening condition and several cases of hyperglycemia have been reported to FDA.
10-28-05 MedWatch - The FDA Safety Information and Adverse Event Reporting Program Biogen Idec and FDA notified healthcare professionals of revision to BOXED WARNINGS, WARNINGS, and ADVERSE REACTIONS sections of the Prescribing Information to describe severe cutaneous or mucocutaneous reactions, some with fatal outcome, that have been reported in association with the Zevalin therapeutic regimen in the post-marketing experience. Patients experiencing a severe cutaneous or mucocutaneous reaction should not receive any further components of the Zevalin therapeutic regimen and should seek prompt medical evaluation.
11-02-05 Omron Healthcare Inc. initiated a voluntary recall of certain Omron(r) 3-Way Instant Thermometers - model numbers MC-600 and MC-600CAN - due to overheating of the tip. Omron had received consumer complaints indicating discomfort during and following use of the thermometers. Consumers who continue using the affected thermometers are at risk of discomfort during use, potentially resulting in redness or even a blister on the skin. Very young children using this device are at an increased risk due to the inability to express themselves and to their difficulty in pulling away from the device held by an adult. The battery-operated, digital thermometers, available through drug stores, the pharmacy sections of food stores and mass merchandise chains, and internet retailers were sold in the United States and Canada between Sept. 19, 2001, and October 21, 2005.
11-04-05 Ligand Pharmaceuticals Inc. and FDA notified healthcare professionals of revisions to BOXED WARNING, WARNINGS, PRECAUTIONS, CLINICAL PHARMACOLOGY, and DOSAGE AND ADMINISTRATION sections of the prescribing information to highlight and strengthen the warning that patients should not consume alcohol while taking Avinza. Additionally, patients must not use prescription or non-prescription medications containing alcohol while on Avinza therapy.
11-10-05 MedWatch - The FDA Safety Information and Adverse Event Reporting Program FDA notified physicians, nurses, medical technologists, pharmacists and other healthcare professionals of the potential for life-threatening falsely elevated glucose readings in patients who have received parenteral products containing maltose or galactose, or oral xylose, and are subsequently tested using glucose dehydrogenase pyrroloquinolinequinone (GDH-PQQ) based glucose monitoring systems. There have been reports of the inappropriate administration of insulin and consequent life-threatening/fatal hypoglycemia in response to erroneous test results obtained from patients receiving parenteral products containing maltose. Cases of true hypoglycemia can go untreated if the hypoglycemic state is masked by false elevation of glucose readings. A preliminary listing of U.S. products that may cause glucose test interference is provided.
11-10-05 MedWatch - The FDA Safety Information and Adverse Event Reporting Program Biogen Idec and FDA notified healthcare professionals of revisions to CONTRAINDICATIONS section of the prescribing information for Amevive, indicated for the treatment of adult patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy. Amevive should not be administered to patients infected with HIV. Amevive reduces CD4+ T lymphocyte counts, which might accelerate disease progression or increase complications of disease in these patients. In addition, other sections of the product labeling were revised to reflect additional safety information.
11-14-05 MedWatch - The FDA Safety Information and Adverse Event Reporting Program FDA notified healthcare professionals and patients of revisions to the label for Ortho Evra, a skin patch approved for birth control, that includes a bolded warning about higher exposure to estrogen for women using the weekly patch compared to taking a daily birth control pill containing 35 micrograms of estrogen. A woman on Ortho Evra may be exposed to approximately 60% more estrogen than if she were taking a typical 35 microgram estrogen birth control pill. Estrogen use is linked to blood clots in the legs and lungs and other clotting problems such as strokes and heart attacks. It is not known if women using Ortho Evra have a higher risk of serious side effects than women taking the typical 35 microgram estrogen pills.
11-16-05 MedWatch - The FDA Safety Information and Adverse Event Reporting Program Risk of Electromagnetic Interference with Medical Telemetry Systems Operating in the 460-470 MHz Frequency Bands FDA issued a Public Health Notification regarding increased risk for electromagnetic interference in any medical telemetry systems operating in the 460-470 MHz frequency bands after December 31, 2005. This interference could compromise patient safety. In January 2006 the Federal Communications Commission will begin issuing new licenses for mobile radio transmitters to operate in the 460-470 MHz band. According to tests conducted by the FDA, the transmitters operating under new licenses in this frequency band can interfere with medical telemetry systems. This could lead to lapses in patient monitoring and missed alarm events, putting patients at risk. The anticipated interference will not be limited to urban areas. Any medical facility in the vicinity of a mobile radio could be affected.
11-18-05 MedWatch - The FDA Safety Information and Adverse Event Reporting Program FDA and Novartis Nutrition Corporation notified healthcare professionals of a recall of 2,712 bottles of an enteral feeding formula that was incorrectly labeled as Diabetisource AC 1.5 Liter bottles lot 2135L. The affected product was shipped nationwide and is only distributed to healthcare institutional facilities. The bottles contain sodium and calcium caseinate, components of milk. People with an allergy or severe sensitivity to milk may run the risk of a serious or life threatening allergic reaction if they consume this product. Healthcare professionals administering Diabetisource AC to patients who have an allergy or sensitivity to milk should immediately stop using this product.
11-18-05 MedWatch - The FDA Safety Information and Adverse Event Reporting Program FDA notified manufacturers of Advair Diskus, Foradil Aerolizer, and Serevent Diskus to update their existing product labels with new warnings and a Medication Guide for patients to alert health care professionals and patients that these medicines may increase the chance of severe asthma episodes, and death when those episodes occur. All of these products contain long-acting beta2-adrenergic agonists (LABA). Even though LABAs decrease the frequency of asthma episodes, these medicines may make asthma episodes more severe when they occur. A Medication Guide with information about these risks will be given to patients when a prescription for a LABA is filled or refilled.
11-22-05 MedWatch - The FDA Safety Information and Adverse Event Reporting Program Boehringer Ingelheim and FDA notified healthcare professionals of revisions to PRECAUTIONS and ADVERSE REACTIONS sections of the prescribing information for Flomax, indicated for the treatment of the signs and symptoms of benign prostatic hyperplasia (BPH). A surgical condition termed Intraoperative Floppy Iris Syndrome (IFIS) has been observed during phacoemulsification cataract surgery in some patients treated with alpha-1 blockers including Flomax. Most of these reports were in patients taking the alpha-1 blocker when IFIS occurred, but in some cases alpha-1 blocker had been stopped prior to surgery. It is recommended that male patients being considered for cataract surgery, as part of their medical history, be specifically questioned to ascertain whether they have taken Flomax or other alpha-1 blockers. If so, the patient's ophthalmologist should be prepared for possible modifications to their surgical technique that may be warranted should IFIS be observed during the procedure.
11-22-05 MedWatch - The FDA Safety Information and Adverse Event Reporting Program Novartis Ophthalmics and FDA notified healthcare professionals and patients of a voluntary recall due to a lack of sterility assurance of seven lots of two products, GenTeal Gel and GenTeal GelDrops, intended for use to relieve dryness of the eye. While the risk of potential contamination is believed to be very low, contaminated product could cause infections in susceptible people. The five lots of GenTeal Gel include about 142,500 tubes that were distributed nationwide from March to November 2004. The two lots of GenTeal GelDrops include about 12,000 dropper bottles that were distributed nationwide in October 2005. Test results for GenTeal Gel indicated the presence of mold in a small number of samples, leading Novartis to initiate a recall of the five lots. The species of mold that is suspected is generally not harmful, but has the potential to cause an eye infection in susceptible people, especially in those with compromised immune systems.
11-30-05 MedWatch - The FDA Safety Information and Adverse Event Reporting Program FDA notified consumers, caregivers, and healthcare professionals that MBI Distributing, Inc. (MBI), also known as Molecular Biologics, an over-the-counter [OTC] drug manufacturer of eye drops and other products will cease manufacturing and distributing drugs until it corrects manufacturing deficiencies and other violations. MBI's product line includes eye drops sold under the brand names Oxydrops, Bright Eyes, Bright Eyes II, Clarity Vision for Life, Visitein, and Can-C, as well as several OTC pain relieving drugs. These products are sold by retailers nationwide. FDA determined that the firm lacked manufacturing controls to ensure that its eye drops were sterile. FDA has also determined that two of the firm's eye drop brands, Visitein and Clarity Vision for Life, are unapproved drugs. In addition, three of the firm's OTC pain relieving drugs, Biogesic, Bio-Ice, and Bio-Heat, do not provide adequate warnings for their safe use. FDA recommends that consumers, health care providers, and caregivers dispose of the Oxydrops, Bright Eyes, Bright Eyes II, Clarity Vision for Life, Visitein, and Can-C brands of eye drops and the Biogesic, Bio-Ice, and Bio-Heat pain relieving drugs.
12-01-05 MedWatch - The FDA Safety Information and Adverse Event Reporting Program Novo Nordisk and FDA notified healthcare professionals of revisions to the WARNINGS and ADVERSE REACTIONS sections of the prescribing information for NovoSeven, to provide updated safety information on thrombotic and thromboembolic adverse events, based on clinical studies in non-hemophilia patients and on post-marketing safety surveillance. A clinical study in elderly, non-hemophiliac, intracerebral hemorrhage patients indicated a potential increased risk of arterial thromboembolic adverse events with use of NovoSeven, including myocardial ischemia, myocardial infarction, cerebral ischemia and/or infarction.
12-01-05 MedWatch - The FDA Safety Information and Adverse Event Reporting Program Amgen, Ortho Biotech and FDA notified healthcare professionals of revision to the WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, and DOSAGE AND ADMINISTRATION sections of the prescribing information for these three products. The revised labeling provides updated safety information on reports of pure red cell aplasia and severe anemia, with or without other cytopenias, associated with neutralizing antibodies to erythropoietin in patients treated with these products. This has been reported predominantly in patients with CRF receiving these products by subcutaneous administration. Recommendations for evaluation and treatment are provided in the new prescribing information.
12-02-05 MedWatch - The FDA Safety Information and Adverse Event Reporting Program Mallinckrodt, Palatin Technologies and FDA notified healthcare professionals of postmarketing reports of serious and life-threatening cardiopulmonary events following the administration of NeutroSpec [Technetium (99m Tc) fanolesomab],a radiodiagnostic agent consisting of a murine IgM monoclonal antibody formulated to be labeled with technetium,indicated for scintigraphic imaging of patients with equivocal signs and symptoms of appendicitis who are five years of age or older. Onset of these events generally occurred within minutes of injection and included two deaths attributed to cardiopulmonary failure within 30 minutes of injection. Additional cases of serious cardiopulmonary events including cardiac arrest, hypoxia, dyspnea and hypotension required resuscitation with fluids, vasopressors, and oxygen. Any patient who receives NeutroSpec should be closely monitored for at least one hour following product administration. Resuscitation equipment and appropriately trained personnel must be readily available during this time. Patients with underlying cardiopulmonary conditions may be at higher risk for serious complication. NeutroSpec administration to these patients should only follow careful consideration of the known and potential risks and benefits, including the possibly higher risks.
12-05-05 MedWatch - The FDA Safety Information and Adverse Event Reporting Program A correction has been made to the September 2005 Safety Labeling Changes (posted on 11/30/05). Avastin was removed from the list as no changes were made to the safety sections of the Avastin labeling during September 2005. The labeling that was provided, however, is the currently approved labeling for Avastin. Safety-related drug labeling changes for September 2005 have been posted on the MedWatch website. The September 2005 posting includes 37 drug products with safety labeling changes to the CONTRAINDICATIONS, BOXED WARNING, WARNINGS, PRECAUTIONS, or ADVERSE REACTIONS sections.
12-08-05 MedWatch - The FDA Safety Information and Adverse Event Reporting Program
The FDA has determined that exposure to paroxetine in the first trimester of pregnancy may increase the risk for congenital malformations, particularly cardiac malformations. At the FDA's request, the manufacturer has changed paroxetine's pregnancy category from C to D and added new data and recommendations to the WARNINGS section of paroxetine's prescribing information. FDA is awaiting the final results of the recent studies and accruing additional data related to the use of paroxetine in pregnancy in order to better characterize the risk for congenital malformations associated with paroxetine.
Physicians who are caring for women receiving paroxetine should alert them to the potential risk to the fetus if they plan to become pregnant or are currently in their first trimester of pregnancy. Discontinuing paroxetine therapy should be considered for these patients. Women who are pregnant, or planning a pregnancy, and currently taking paroxetine should consult with their physician about whether to continue taking it. Women should not stop the drug without discussing the best way to do that with their physician.
12-13-05 MedWatch - The FDA Safety Information and Adverse Event Reporting Program FDA and Bedford Laboratories, a division of Ben Venue Laboratories, Inc., Bedford, Ohio, announced that it is voluntarily recalling one lot of Methotrexate for Injection (preservative free), USP 1 gram per vial (NDC 55390-143-01), Lot # 859142, exp 09/07, because the active drug substance ("ADS") used to manufacture Lot # 859142, contained low levels of ethylene glycol. Preservative-free Methotrexate is the only formulation that is acceptable for intrathecal administration. Healthcare professionals and suppliers should not distribute these vials and should contact Bedford Laboratories for return instructions. Consumers that have received this product and have questions should contact their physicians.
12-14-05 MedWatch - The FDA Safety Information and Adverse Event Reporting Program The FDA has classified Baxter Healthcare Corporation's Meridian Hemodialyis (HD) Instrument (Product Codes 5M5576 and 5M5576R) as a Class I recall. There have been reports of hemolysis related to kinks in the blood tubing sets used with the Meridian. To date, there have been reports of one death and at least one serious injury, associated with kinking of blood tubing sets routed through both channels of the clips mounted on the front of the Meridian. This classification does not require the return of Meridian instruments currently in the market. In the September 28, 2005 letter, Baxter directs customers to route blood tubing through only one channel of the two channel clips mounted on the front of the Meridian to reduce the risk of blood tubing kinks. Baxter also provided labels with the September 28, 2005, customer letter to be affixed to Meridian instruments. The labels clearly display the proper routing of the blood tubing sets. Further, Baxter asks that all care providers be trained on this procedure. In addition, Baxter will be providing modified tubing clips to eliminate related safety issues as soon as possible.
12-19-05 MedWatch - The FDA Safety Information and Adverse Event Reporting Program FDA issued a public health advisory to inform patients and health care providers that Palatin Technologies, the manufacturer of Neutrospec (Technetium (99m Tc) fanolesomab) is voluntarily suspending marketing of Neutrospec effective immediately due to serious safety concerns. Neutrospec is an antibody radio-labeled with technetium-99m, indicated for radiologic imaging of patients with unclear signs and symptoms of appendicitis who are five years of age and older. FDA received reports from Palatin Technologies of 2 deaths and 15 additional life-threatening adverse events in patients receiving Neutrospec. These events occurred within minutes of administration of Neutrospec and included shortness of breath, low blood pressure, and cardiopulmonary arrest. A review of all post-marketing reports showed an additional 46 patients who experienced adverse events that were similar but less severe. All of the reactions occurred immediately after NeutroSpec was administered. The decision to suspend marketing was based on the life-threatening nature of the events and the availability of other means to diagnose appendicitis that do not carry these risks. FDA urges health care providers to discontinue use of existing stocks of Neutrospec and to contact Palatin Technologies regarding their return.
12-20-05 MedWatch - The FDA Safety Information and Adverse Event Reporting Program Endologix and FDA notified healthcare professionals of the voluntary product recall of selected Powerlink System delivery catheters marketed in the U.S., used to deliver minimally invasive treatment for abdominal aortic aneurysms. Endologix initiated the recall as a result of an analysis of three recent reports of tip separation from the catheter sheath inner core during procedures. This action does not include the Powerlink stent grafts that have been implanted in patients or the large diameter 34 mm Powerlink System being evaluated under an investigational device exemption or Powerlink Systems sold outside of the U.S.
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