- Boston Scientific Mach 1 Guide Catheters
- Audience: Hospital risk managers, cardiovascular healthcare professionals
[Posted 12/22/2006] Boston Scientific Corporation and FDA informed healthcare professionals of a recall of 12 lots of Mach 1 Guide Catheters, used to deliver medical devices to the heart to treat coronary artery diesease. The affected product was distributed to hospitals in the United States. Some product units of the affected lots may contain excess strands of resin in the inner lumen near the hub of the guide catheter. If excess resin is present in the catheter and detaches during a procedure, there is the potential for embolization. If an obstruction occurs in a major blood vessel or multiple small blood vessels, it may result in serious complications such as stroke, heart attack or kidney problems.
[December 15, 2006 - Press Release - Boston Scientific]
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- Rituxan (Rituximab)
- Audience: Oncologists, Rheumatologists, other healthcare professionals, and consumers
Indication: Treatment of CD20-postive, B-cell, non-Hodgkins lymphoma and for moderately-to-severely-active rheumatoid arthritis when there has been inadequate response to other treatments.
[Posted 12/18/2006] FDA and Genentech informed healthcare professionals of important emerging safety information about Rituxan. Two patients died after being treated with Rituxan for systemic lupus erythematosus (SLE). Rituxan is approved for the above indication and is prescribed off-label for other serious diseases and conditions such as SLE. The cause of death was a viral infection of the brain called progressive multifocal leukoencephalopathy (PML) that is caused by reactivated JC virus which is present in about 80 percent of adults. Physicians should maintain a high index of suspicion for the development of PML in patients under treatment with Rituxan.
[December 18, 2006 - Healthcare Professional Sheet - FDA]
[December 18, 2006 - Public Health Advisory - FDA]
[December 18, 2006 - Drug Information Page - FDA]
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- Quinine products
- Audience: Pharmacists, other healthcare professionals and consumers
[Posted 12/12/2006] FDA informed healthcare professionals and consumers that the Agency ordered firms to stop marketing unapproved drug products containing quinine, citing serious safety concerns, including deaths associated with quinine products. There are multiple unapproved products containing quinine currently on the market, used off-label to treat leg cramps and similar conditions. Since 1969, FDA received 665 reports of adverse events with serious outcomes associated with quinine use, including 93 deaths. Quinine drugs are associated with serious side effects, such as cardiac arrhythmias, thrombocytopenia, and severe hypersensitivity reactions. Qualaquin, manufactured by Mutual Pharmaceutical Company, is the only quinine product approved by the FDA.
[December 12, 2006 - Press Release - FDA]
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- Heparin Sodium Injection
- Audience: Vascular surgeons, ER personnel, pharmacists, and other healthcare professionals
[Posted 12/08/2006] FDA notified healthcare professionals of revisions to the WARNINGS section of the prescribing information for Heparin to inform clinicians of the possibility of delayed onset of heparin-induced thrombocytopenia (HIT), a serious antibody-mediated reaction resulting from irreversible aggregation of platelets. HIT may progress to the development of venous and arterial thromboses, a condition referred to as heparin-induced thrombocytopenia and thrombosis (HITT). Thrombotic events may be the initial presentation for HITT which can occur up to several weeks after the discontinuation of heparin therapy. Patients presenting with thrombocytopenia or thrombosis after discontinuation of heparin should be evaluated for HIT and HITT.
[October 2006 - Label - Baxter]
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- Compounded topical anesthetic creams
- Audience: Consumers, Pharmacists and other healthcare professionals
[Posted 12/06/2006] FDA notified healthcare professionals and consumers about the serious public health risks related to compounded topical anesthetic creams. FDA issued warning letters to five firms to stop compounding and distributing standardized versions of topical anesthetic creams, marketed for general distribution. Exposure to high concentrations of local anesthetics, like those in compounded topical anesthetic creams, can cause grave reactions including seizures, irregular heartbeats and death. Compounded topical anesthetic creams are often used to lessen pain in procedures such as laser hair removal, tattoos, and skin treatments. They may be dispensed by clinics and spas that provide these procedures, or by pharmacies and doctors’ offices.
[December 05, 2006 - News Release - FDA]
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- Dolophine (methadone hydrochloride)
- Audience: Pain management specialists, pharmacists, and other healthcare professionals
Indication: Treatment of moderate to severe pain not responsive to non-narcotic analgesics; detoxification of opioid addiction; and maintenance treatment of opioid addiction
[Posted 11/27/2006] FDA notified healthcare professionals of reports of death and life-threatening adverse events such as respiratory depression and cardiac arrhythmias in patients receiving methadone. These adverse events are the possible result of unintentional methadone overdoses, drug interactions, and methadone's cardiac toxicities (QT prolongation and Torsades de Pointes). The reports underscore the importance of knowing methadone's toxicities and unique pharmacologic properties, including dosing and monitoring recommendations.
[November 27, 2006 - Public Health Advisory - FDA]
[November 27, 2006 - Patient Package Insert - Roxane]
[November 27, 2006 - Healthcare Professional Sheet - FDA]
[November 27, 2006 - Prescribing Information - Roxane]
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- Complete MoisturePLUS Contact Lens Care Products
- Audience: Ophthalmologists, optometrists, other healthcare professionals and consumers
Indication: Contact lens care
[Posted 11/22/2006] FDA and Advanced Medical Optics, Inc. informed healthcare professionals and consumers of a nationwide recall of 18 lots of Complete MoisturePLUS multipurpose contact lens care solution and Active Packs distributed in the United States. Certain lots were found to have bacterial contamination which compromised sterility. Non-sterility of a contact lens solution may have serious health consequences, including eye infection and microbial keratitis.
Contact lens users who have the recalled product should discontinue use immediately and individuals who experience symptoms of an eye infection such as redness, pain, tearing, increased light sensitivity, blurry vision, discharge or swelling, should remove their lenses and consult their eye care provider immediately.
[November 21, 2006 - Press Release - Advanced Medical Optics, Inc.]
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- Erythropoiesis Stimulating Agents
Procrit, Epogen, and Aranesp
- Audience: Oncologists, nephrologists, and other healthcare professionals
Indication: Treatment of anemia associated with chronic renal failure, including patients on dialysis and patients not on dialysis.
[Posted 11/17/2006] FDA notified healthcare professionals of a newly published clinical study showing that patients treated with an erythropoiesis-stimulating agent (ESA) and dosed to a target hemoglobin concentration of 13.5 g/dL are at a significantly increased risk for serious and life threatening cardiovascular complications, as compared to use of the ESA to target a hemoglobin concentration of 11.3 g/dL. The “Correction of Hemoglobin and Outcomes in Renal Insufficiency” study, published November 16, 2006 in the New England Journal of Medicine, reports the adverse cardiovascular complications as a composite of the occurrence of one of the following events: death, myocardial infarction, hospitalization for congestive heart failure, or stroke.
The study findings underscore the importance of following the currently approved prescribing information for Procrit, Epogen, and Aranesp, including the dosing recommendation that the target hemoglobin not exceed 12 g/dL.
[November 16, 2006 - Information for Healthcare Professionals - FDA] PDF
[November 16, 2006 - Public Health Advisory - FDA]
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- Tamiflu (oseltamivir phosphate)
- Audience: Pediatric and primary care healthcare professionals and patients
[Posted 11/13/2006] Roche and FDA notified healthcare professionals of revisions to the PRECAUTIONS/Neuropsychiatric Events and Patient Information sections of the prescribing information for Tamiflu, indicated for the treatment of uncomplicated acute illness due to influenza infection in patients 1 year and older who have been symptomatic for no more than 2 days and for the prophylaxis
of influenza in patients 1 year and older.There have been postmarketing reports (mostly from Japan) of self-injury and delirium with the use of Tamiflu in patients with influenza. People with the flu, particularly children, may be at an increased risk of self-injury and confusion shortly after taking Tamiflu and should be closely monitored for signs of unusual behavior. A healthcare professional should be contacted immediately if the patient taking Tamiflu shows any signs of unusual behavior.
[November 13, 2006 - Letter - Roche]
[November 13, 2006 - Prescribing Information - Roche]
[November 13, 2006 - Patient Package Insert - Roche]
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- Acetaminophen 500 mg Caplets by Perrigo Company
- Audience: Healthcare professionals and consumers
[Posted 11/09/2006] FDA and Perrigo Company notified the public of a voluntary recall of 383 lots of acetaminophen 500 mg caplets manufactured and distributed under various store-brands as a result of small metal fragments found in a small number of these caplets. Consumers can determine if they are in possession of a recalled product by locating the batch number printed on the container label. A list of stores that carry store-brands potentially affected by this recall, as well as batch numbers affected, is located on FDA's website (referenced below).
To date, there have been no illness or injuries received related to this problem and no consumer complaints have been reported to the FDA or to Perrigo. Based on information currently available, the FDA believes the probability of serious adverse health consequences is remote; however, if a consumer were to swallow an affected caplet, it could result in minor stomach discomfort and/or possible cuts to the mouth or throat. Consumers should consult their physician if they suspect they've been harmed by use of this product.
[November 9, 2006 - News Release - FDA]
[November 9, 2006 - Perrigo Voluntary Product Recall Customer List - FDA]
[November 9, 2006 - Perrigo
Recalled Batches - FDA]
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- Heartland Repack Services products
- Audience: Pharmacists and nursing home administrators
[Posted 10/25/2006] Heartland Repack Services and FDA notified healthcare professionals of a voluntary recall of all products containing a lot number beginning with “K” (example: K12345). Drugs repackaged by Heartland Repack Services are distributed through their own pharmacy services to Omnicare nursing homes and other institutional facilities. Omnicare is responsible for 1.4 million nursing home and healthcare patients in 47 states and Canada. These product lots are distributed in 30, 60, 90 count size boxes and 250 count bags. Both the boxes and bags contain unit dose strips of five tablets per strip. This recall was initiated because there is the potential for mislabeling and packaging mix-up.
Due to incomplete accounting of product subject to this recall, on October 20, 2006 Heartland Repack Services issued a follow-up notice of the July 2006 recall.
[July 27, 2006 - Recall Notice - Heartland Repack Services]
[July 27, 2006 - Recalled Product List - Heartland Repack Services] (1.7 MB pdf file, 119 pages)
[October 20, 2006 - Follow-up Questionnaire - Heartland Repack Services]
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- Effexor XR (venlafaxine HCl) Extended-Release Capsules
Effexor (venlafaxine HCl) Tablets
- Audience: Neuropsychiatric and other healthcare professionals
[Posted 10/25/2006] Wyeth and FDA notified healthcare professionals of revisions to the OVERDOSAGE/Human Experience section of the prescribing information for Effexor (venlafaxine HCl), indicated for treatment of major depressive disorder. In postmarketing experience, there have been reports of overdose with venlafaxine, occurring predominantly in combination with alcohol and/or other drugs. Published retrospective studies report that venlafaxine overdosage may be associated with an increased risk of fatal outcome compared to that observed with SSRI antidepressant products, but lower than that for tricyclic antidepressants. Healthcare professionals are advised to prescribe Effexor and Effexor XR in the smallest quantity of capsules consistent with good patient management to reduce the risk of overdose.
[October 17, 2006 - Letter - Wyeth]
[August, 2006 - Effexor Label - Wyeth]
[August, 2006 - Effexor XR Label - Wyeth]
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- Menactra (Meningococcal Conjugate Vaccine A, C, Y, and W135)
- Audience: Neurological and Pediatric healthcare professionals, and consumers
[Posted 10/23/2006] FDA and CDC updated an October 2005 alert to consumers and health care providers regarding reports of Guillain Barre Syndrome (GBS) following administration of Meningococcal Conjugate Vaccine A, C, Y, and W135, manufactured by Sanofi Pasteur. To date a total of 15 confirmed cases of GBS among individuals 11-19 years of age occurring within six weeks of vaccination with Menactra have been reported to the Vaccine Adverse Event Reporting System (VAERS). Two additional cases have been confirmed in persons 20 years of age and older. All individuals are reported to be recovering or have recovered.
While the cases reported suggest a small increased risk of GBS following immunization with Menactra, the limitations in VAERS, and the uncertainty regarding background incidence rates for GBS require that these findings be viewed with caution. At this time, CDC and FDA cannot determine with certainty whether Menactra does increase the risk of GBS in persons who receive the vaccine and, if so, to what degree. At the present time, there are no changes in recommendations for vaccination and individuals should continue to follow their doctors' recommendations. FDA asks any persons with knowledge of possible cases of GBS occurring after receiving Menactra to report them to VAERS at http://www.vaers.hhs.gov or by phone at 1-800-822-7967.
[October 20, 2006 - Statement - FDA]
[October 20, 2006 - MMWR Update - CDC]
Previous MedWatch alert:
[October 03, 2005]
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- Roche Diagnostics CoaguChek PT Test Strips
- Audience: Consumers, Physicians and Hospital risk managers and laboratory managers
[Posted 10/20/2006] Roche Diagnostics and FDA informed consumers and healthcare professionals of the recall of CoaguChek PT test strips used to determine blood clotting time of patients taking anti-coagulant medication to prevent blood clots. The recall was due to the potential for a test strip defect that may cause falsely elevated test results. This may result in an incorrect dose of anti-coagulant medication or unnecessary corrective measures being taken to reduce the effect of circulating anti-coagulants. Healthcare professionals who use CoaguChek PT test strips should institute 'duplicate testing', or use two strips with different lot numbers, on each patient to reduce the risk of bias. Home users of CoaguChek PT test strip should immediately discontinue use of the product and contact their healthcare provider.
[October 20, 2006 - Press Release - Roche Diagnostics]
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- Gleevec (imatinib mesylate)
- Audience: Oncology and cardiology healthcare professionals
[Posted 10/19/2006] Novartis and FDA notified healthcare professionals about revisions to the PRECAUTIONS section of the prescribing information, describing the occasional occurrence of severe congestive heart failure and left ventricular dysfunction in patients taking Gleevec. Most of the patients with reported cardiac events had other co-morbidities and risk factors, including advanced age and previous medical history of cardiac disease. Patients with cardiac disease or risk factors for cardiac failure should be monitored carefully and any patients with signs or symptoms consistent with cardiac failure should be evaluated and treated.
[October 19, 2006 - Letter - Norvartis] PDF
[September 2006 - Label - Novartis]
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- LifeScan One Touch Blood Glucose Test Strips -- Counterfeit Alert
- Audience: Pharmacists, other healthcare professionals and patients
[UPDATE 03/12/2007] Class I Recall expanded to include additional lot numbers of the One Touch Ultra (2691261) and Basic/Profile Blood Glucose Test Strips (2615211 and 227078A).
[UPDATE 02/06/2007] Matrix Distributors Inc. added as recalling firm.
[UPDATE 12/12/2006] Recall classified as Class I because use of the counterfeit products could cause serious injury or death. Recall includes One Touch Basic/Profile Blood Glucose Test Strips (Lot Numbers 272894A, 2619932, 2606340 50-count packages) and One Touch Ultra Blood Glucose Test Strips, LifeScan [lot Numbers 2691191, 50-count test strips (2 vials of 25 test strips)].
[UPDATE 10/24/2006] FDA provided two additional lot numbers that are included in the distribution of counterfeit products, along with descriptions of how to identify them.
[Posted 10/13/2006] LifeScan and FDA notified healthcare professionals and the public of counterfeit blood glucose test strips being sold in the United States for use with various models of the One Touch Brand Blood Glucose Monitors used by people with diabetes to measure their blood glucose. The counterfeit test strips potentially could give incorrect blood glucose values--either too high or too low--which might result in a patient taking either too much or too little insulin and lead to serious injury or death.
[December 12, 2006 - Recall Notice One Touch Ultra Blood Glucose Test Strips - FDA]
[December 12, 2006 - Recall Notice One Touch Basic/Profile Blood Glucose Test Strips - FDA]
[October 23, 2006 - News Release - FDA]
[October 13, 2006 - News Release - FDA]
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- Coumadin (warfarin sodium)
- Audience: Pharmacists, other healthcare professionals, and patients
[Posted 10/06/2006] FDA and Bristol-Myers Squibb notified pharmacists and physicians of revisions to the labeling for Coumadin, to include a new patient Medication Guide as well as a reorganization and highlighting of the current safety information to better inform providers and patients.
The 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. Information about all currently approved Medication Guides is available at http://www.fda.gov/cder/Offices/ODS/medication_guides.htm.
[October 2006 - Medication Guide - Bristol-Myers Squibb]
[October 2006 - Label - Bristol-Myers Squibb]
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- Isotretinoin - Accutane and generic isotretinoin
- Audience: Dermatological, other healthcare professionals and patients
[Posted 10/06/2006] FDA and the iPLEDGE program notified healthcare professionals and patients of an update to iPLEDGE, a risk management program to reduce the risk of fetal exposure to isotretinoin, that will eliminate one element of the program, the 23 day lock-out period for males and females of non-child bearing potential. This change does not affect female patients of child-bearing potential.
[October 06, 2006 - Letter - iPLEDGE Program]
[October 06, 2006 - Drug Information Page - FDA]
[October 06, 2006 - Questions and Answers - FDA]
Previous MedWatch alert:
[August 12, 2005]
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- Lamictal (lamotrigine)
- Audience: Neurologists, obstetricians, other healthcare professionals, and patients
[Posted 09/29/2006] The FDA notified healthcare professionals and patients of new preliminary information from the North American Antiepileptic Drug Pregnancy Registry that suggests that babies exposed to Lamictal, indicated to treat seizures and bipolar disorder, during the first three months of pregnancy may have a higher chance of being born with a cleft lip or cleft palate. More research is needed to be sure about the possibility of the increased chance of cleft lip or cleft palate developing in babies of pregnant women who take Lamictal. Women who take Lamictal and are pregnant or are thinking of becoming pregnant should talk with their doctor. Patients should not start or stop using Lamictal without talking to their doctor.
[September 28, 2006 - Patient Information Sheet - FDA]
[September 28, 2006 - Healthcare Professional Sheet - FDA]
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- Avastin (bevacizumab)
- Audience: Oncological and neurological healthcare professionals
[Posted 09/25/2006] Genentech and FDA notified healthcare professionals about revisions to the WARNINGS and ADVERSE REACTIONS sections of the prescribing information to inform healthcare professionals of 1] cases of a rare brain-capillary leak syndrome [reversible posterior leukoencephalopathy syndrome (RPLS)] and 2] postmarketing reports of nasal septum perforation.
RPLS is a neurological disorder associated with hypertension, fluid retention and cytotoxic effects of immunosuppressive drugs on the vascular endothelium. The syndrome can present with headache, seizure, lethargy, confusion, blindness and other visual and neurologic disturbances. Mild to severe hypertension may be present, but is not necessary for diagnosis. The onset of symptoms has been reported to occur from 16 hours to 1 year after initiation of Avastin. Magnetic Resonance Imaging (MRI) is necessary to confirm the diagnosis of RPLS.
[September, 2006 - Updated Prescribing Information - Genentech]
[September, 2006 - Dear Healthcare Professional letter - Genentech]
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- Ortho Evra (norelgestromin/ethinyl estradiol)
- Audience: Gynecologists, other healthcare professionals and consumers
[Posted 09/20/2006] Ortho-McNeil and FDA notified healthcare professionals and patients about revisions to the prescribing information to inform them of the results of two separate epidemiology studies that evaluated the risk of developing a serious blood clot in women using Ortho Evra compared to women using a different oral contraceptive. The first study found that the risk of non-fatal venous thromboembolism (VTE) associated with the use of Ortho Evra contraceptive patch is similar to the risk associated with the use of oral contraceptive pills containing 35 micrograms of ethinyl estradiol and norgestimate.The second study found an approximate two-fold increase in the risk of medically verified VTE events in users of Ortho Evra compared to users of norgestimate-containing oral contraceptives containing 35 micrograms of estrogen. Although the results of the two studies differ, the results of the second study support FDA's concerns regarding the potential for Ortho Evra use to increase the risk of blood clots in some women.
Prescribing information for Ortho Evra continues to recommend that women with concerns or risk factors for thromboembolic disease talk with their healthcare professionals about using Ortho Evra versus other contraceptive options.
[September 20, 2006 - Updated Prescribing Information - Ortho-McNeil]
[September 20, 2006 - Q&A's - FDA]
[September 20, 2006 - Drug Information Page - FDA]
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- Ibuprofen and Aspirin Taken Together
- Audience: Consumers and healthcare professionals
[Posted 09/08/2006] FDA notified consumers and healthcare professionals that taking Ibuprofen for pain relief and aspirin at the same time may interfere with the benefits of aspirin taken for the heart. Ibuprofen can interfere with the anti-platelet effect of low dose aspirin (81 mg per day), that may render aspirin less effective when used for cardioprotection and stroke prevention. Although it is all right to use Ibuprofen and aspirin together, FDA recommends that consumers contact their healthcare professional for more information on the timing of when to take these two medicines, so that both medicines can be effective.
[September 8, 2006 - Healthcare Professional Sheet - FDA]
[September 8, 2006 - Science Paper - FDA]
[September 8, 2006 - Drug Information Page - FDA]
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- Ellagimax Capsules, Coral Max Capsules, Coral Max without Iron Capsules, and Advanced Arthritis Support Capsules
- Audience: Consumers and healthcare professionals
[Posted 09/07/2006] FDA notified healthcare professionals and consumers of the seizure of Ellagimax capsules, Coral Max capsules, Coral Max without Iron capsules, and Advanced Arthritis Support capsules distributed by Advantage Nutraceuticals, LLC, because the products, labeled as dietary supplements, are being promoted to treat serious disease conditions, including but not limited to cancer, arthritis, fibromyalgia, and seizures. The products have not been shown to be safe and effective to treat these conditions and have not been approved by the FDA and are therefore in violation of the new drug and misbranding provisions of the Federal Food, Drug and Cosmetic Act.
FDA advised consumers who may be taking these products to consult their physicians.
[September 06, 2006 - News Release - FDA]
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- Human Tissues recovered by Donor Referral Services (DRS)
- Audience: Surgeons, dentists, hospital surgical service managers and risk managers
[Posted 08/31/2006] FDA notified healthcare professionals that human tissues recovered by Donor Referral Services (DRS) may not have met FDA requirements for donor eligibility. While no adverse reactions associated with these tissues have yet been reported, and subsequent processing should reduce the potential risks of infectious disease transmission, healthcare providers who were supplied with these tissues are being notified of the potentially increased risk for infectious disease transmission.
FDA and the Centers for Disease Control and Prevention (CDC) are strongly recommending that healthcare providers inform their patients who received tissues initially recovered by DRS that they may have received tissue from donors for whom adequate donor eligibility determinations were not performed, and offer patients access to appropriate infectious disease testing. The relevant communicable diseases for which a tissue donor is required to be tested are HIV-1 and 2, hepatitis B virus, hepatitis C virus, and syphilis. Further recommendations for testing are posted on the CDC website at: http://www.cdc.gov/ncidod/dhqp/tissueTransplantsFAQ.html. FDA will continue its investigation into this matter and will issue further public health updates, as needed.
[August 30, 2006 - Public Health Notification - FDA]
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- Steris Amsco Sonic Energy Cleaner and Amsco Sonic Energy Console
- Audience: Hospital and long term care facility risk managers and materials managers
[Posted 08/31/2006] Steris and FDA notified hospital and long term care facility managers of a fire risk with use of Amsco Sonic Energy Cleaner and/or an Amsco Sonic Energy Console, used for cleaning reusable medical equipment. The affected products were manufactured from November 2000 until January 2005 bearing serial numbers 0432000018 to 0403105051. The location of the lid switch cable wiring harness in these units makes them susceptible to water damage to the electrical connections. If this occurs, it can cause overheating of the electrical system in the unit and lead to damage of the wiring harness(s) resulting in smoking, sparking, and fire.
Healthcare professionals are instructed to follow proper safety precautions to prevent water from contacting the electrical wiring while using this device. A Steris technician will visit account holders to replace the wire harness and associated components of the affected units.
[June 21, 2006 - Letter - Steris]
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-
- Alaris SE Infusion Pumps
- Audience: Healthcare administrators, risk managers, and healthcare professionals
[UPDATE 09/26/2006] Recall classified as Class I. The manufacturer provided recommendations to users for safe operation of the product. FDA provided Q&As.
[Posted 08/29/2006] FDA and Alaris Products notified healthcare professionals of a recall of defective infusion pumps due to a design defect called "key bounce" that may cause potential over-infusion of medications and result in an infusion rate at least 10 times the intended infusion rate. Infusion pumps are electronic devices intended for controlled delivery of intravenous solutions and medications to patients. Key bounce occurs when a number pressed once on the pump registers twice and not detected during programming verification. The products included in this recall (model numbers 7130,7131, 7230, and 7231) are distributed by Cardinal Health Care 303 Inc. The manufacturer provided recommendations to pump users on steps they can take to minimize key entry errors until the problem can be corrected. Healthcare facilities can continue to use pumps in their possession, guided by the company's instructions.
[September 26, 2006 - Recall Notice - FDA]
[September 26, 2006 - Questions and Answers - FDA]
[August 28, 2006 - Press Release - FDA]
[August 15, 2006 - Recall Letter - Alaris Products]
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-
- Dietary Supplements Containing Ephedrine Alkaloids
- Audience: Consumers and healthcare professionals
[Posted 08/22/2006] FDA informed consumers and healthcare professionals that all dietary supplements containing ephedrine alkaloids are illegal to market in the United States. Dietary supplements containing ephedrine alkaloids, regardless of the dosage, are considered adulterated and pose an unreasonable risk of illness or injury to users, especially those suffering from heart disease and high blood pressure. FDA conducted an exhaustive evaluation of relevant scientific data evidence on ephedrine alkaloids before issuing this decision in a final rule in 2004. On August 17, 2006, a Court of Appeals ruling upheld this final rule, reversing an earlier decision by the District Court of Utah.
[Aug 21, 2006 - Statement - FDA]
[Feb 06, 2004 - News Release - FDA]
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-
- Dexedrine (dextroamphetamine sulfate)
- Audience: Psychiatrists, pediatricians, mental healthcare professionals, pharmacists and consumers
[Posted 08/21/2006] The FDA and GlaxoSmithKline notified healthcare professionals of changes to the BOXED WARNING, WARNINGS and PRECAUTIONS sections of the prescribing information for Dexedrine (dextroamphetamine sulfate), approved for the treatment of Attention-Deficit Hyperactivity Disorder and narcolepsy. The warnings describe reports of sudden death in association with CNS stimulant treatment at usual doses in children and adolescents with structural cardiac abnormalities or other serious heart problems.
[August 04, 2006 - Letter - GlaxoSmithKline]
[June 2006 - Label - GlaxoSmithKline]
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-
- Unapproved Compounded Inhalation Drugs
- Audience: Pharmacists, other healthcare professionals, and consumers
[Posted 08/10/2006] The FDA notified consumers and healthcare professionals that RoTech Healthcare, Inc., CCS Medical, and Reliant Pharmacy Services are manufacturing and distributing unapproved compounded inhalation drugs nationwide. These drugs, compounded by pharmacists, are used to treat life-threatening conditions such as asthma, emphysema, bronchitis, and cystic fibrosis. Compounded inhalation drugs are not reviewed by the FDA for safety and effectiveness and are often not produced according to good drug manufacturing practice, which may expose patients to unnecessary risks. FDA urges consumers using inhalation drugs to discuss their medications with their physicians and verify with their pharmacists that the medications they received are what their physicians ordered. FDA encourages patients to use FDA-approved drugs whenever possible.
[August 10, 2006 - Press Release - FDA]
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-
- Hydralazine HCl Injection, USP, 20 mg/mL
- Audience: Cardiologists, pharmacists and other healthcare professionals
[Updated 8/25/2006] Luitpold Pharmaceuticals, Inc. and FDA notified healthcare professionals of a voluntary recall of additional lots of Hydralazine HCl Injection (20 mg/mL, 1 mL single dose vials) because the products may contain particulates.
[Posted 08/03/2006] Luitpold Pharmaceuticals, Inc. and FDA notified healthcare professionals of a voluntary recall because some vials of Hydralazine HCl Injection from lot number 5561 NO with an expiration date of December, 2006 (20 mg/mL, 1 mL single dose vials) may contain particulates. The lot is labeled with a NOVAPLUS label. Further use or distribution of this lot of product should cease.
[August 11, 2006 - Recall Letter - Luitpold Pharmaceuticals, Inc.]
[July 24, 2006 - Recall Letter - Luitpold Pharmaceuticals, Inc.]
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-
- WellPatch Cough & Cold Soothing Vapor Pads
- Audience: Consumers, Pharmacists and other healthcare professionals
[Posted 08/01/2006] The Mentholatum Company and FDA notified consumers and healthcare professionals about a nationwide recall of WellPatch Cough & Cold Soothing Vapor Pads due to potential serious adverse health effects that could result if the product is ingested by a child removing the patch and chewing on it. This product contains camphor, eucalyptus oil, and menthol. Possible adverse events associated with chewing or ingesting products containing camphor or eucalyptus oils can vary from minor symptoms, such as burning sensation in the mouth, headache, nausea and vomiting, to more severe reactions, such as seizures.
[August 01, 2006 – News Release –The Mentholatum Company]
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-
- At-Home Genetic Tests
- Audience: Consumers and genetics healthcare professionals
[Posted 07/31/2006] FDA, the Federal Trade Commission, and the Centers for Disease Control and Prevention alerted consumers about the facts surrounding the direct-to-consumers marketing of genetic tests.
According to the FDA, which regulates the manufacturers of genetic tests, and the CDC, which promotes health and quality of life, some of these tests lack scientific validity, and others provide medical results that are meaningful only in the context of a full medical evaluation. The FDA and CDC say that because of the complexities involved in both the testing and the interpretation of the results, genetic tests should be performed in a specialized laboratory, and the results should be interpreted by a doctor or trained counselor who understands the value of genetic testing for a particular situation.
[July 31, 2006 – News Release – FDA/CDRH/OIVD]
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- High-Strength Hydrogen Peroxide
- Audience: Consumers, pharmacists, and other healthcare professionals
[Posted 07/27/2006] FDA warned consumers not to purchase or to use high-strength hydrogen peroxide products, including a product marketed as "35 Percent Food Grade Hydrogen Peroxide," for medicinal purposes because they can cause serious harm or death when ingested. FDA recommends that consumers who are currently using high-strength hydrogen peroxide stop immediately and consult their health care provider.
FDA has never approved high-strength hydrogen peroxide to be taken internally and considers hydrogen peroxide at 35 percent strength dangerous, even if handled according to the manufacturer's directions. High-strength hydrogen peroxide -- more than 10 times stronger than the solution used in over-the-counter drugs to disinfect minor cuts -- is highly corrosive. Ingesting hydrogen peroxide can cause gastrointestinal irritation or ulceration. Intravenous (IV) administration of hydrogen peroxide can cause inflammation of the blood vessel at the injection site, gas embolisms (bubbles in blood vessels), and potentially life-threatening allergic reactions.
[July 27, 2006 – News Release – FDA]
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- Medtronic Model 8731 Intrathecal Catheter
Medtronic Model 8598 Intrathecal Catheter Distal Revision Kit
- Audience: Hospital operating room staff and other healthcare professionals, and hospital risk managers
[UPDATE 09/08/2006] Recall classified as Class I.
[Posted 07/21/2006] Medtronic and FDA notified healthcare providers of a voluntary recall of Model 8731 Intrathecal Catheter and Model 8598 Intrathecal Catheter Distal Revision Kit. Medtronic is recalling these products because the platinum-iridium tip may be dislodged by the guide wire during implantation. Dislodgement of the tip can result in the risk of infection or other potentially serious adverse health consequences.
[July 2006 – Dear Healthcare Provider Letter – Medtronic]
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- Ultravist (iopromide) Injection 370mgl/mL, 125 mL
- Audience: Hospital Risk Managers, Imaging Center Administrators, other healthcare professionals
[UPDATED 07/31/2006] Berlex, Inc. and FDA announced a voluntary worldwide recall of all lots of Ultravist (iopromide) Injection 370mgl/mL, 125 ml, due to the presence of particulate matter and crystallization with the potential for thromboembolic safety problems if an affected product is administered to patients.
[Posted 07/21/2006] Berlex, Inc. and FDA announced a voluntary nationwide recall of a single lot (No. 41500A, Exp. 1/2007) of Ultravist (iopromide) Injection 370mgl/mL, 125 ml, an intravenous X-ray contrast agent, due to the presence of particulate matter in conjunction with crystallization. The product was recalled because of the potential for serious safety problems if Ultravist Injection is administered to patients. These problems may include thrombosis of blood vessels, thromboembolism and injury or infarction of end organs such as heart, kidney, and brain.
Hospitals, imaging centers and other healthcare facilities should not use any of the affected lot number (41500A) of Ultravist Injection 370mgL/mL, 125 mL for patient care and should immediately quarantine any product for return.
[July 31, 2006 - Press Release - Berlex]
[July 21, 2006 - Press Release - Berlex]
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- Bismacine/Chromacine
- Audience: All Healthcare professionals and consumers
[Posted 07/21/2006] FDA notified healthcare professionals and consumers not to use an injectable product called Bismacine, also known as Chromacine. Bismacine is not a pharmaceutical and has not been approved to treat any condition; however, it is being prescribed or administered by doctors of "alternative health" to treat Lyme disease.
This product contains high amounts of bismuth, a heavy metal that is used in some medications taken by mouth to treat Helicobacter pylori, a bacteria that can cause stomach ulcers. However, Bismacine is not approved in any form for use by injection.
The FDA is investigating one report of a death and several reports of injury related to the administration of Bismacine. Individuals who believe they have suffered adverse events from receiving Bismacine should seek medical attention. Possible effects of bismuth poisoning include cardio-vascular collapse and kidney failure.
[July 21, 2006 - Press Release - FDA]
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- SSRIs and Treatment Challenges of Depression in Pregnancy
- Audience: Neuropsychiatric and other healthcare professionals, and consumers
[Posted 07/19/2006] FDA notified healthcare professionals and consumers of important information from two recent studies that should be considered when making treatment decisions in pregnant women who take antidepressants. The studies included pregnant women who were treated with selective serotonin reuptake inhibitors (SSRIs), or in a few cases, other antidepressant medications.
One study illustrated the potential risk of relapsed depression after stopping antidepressant medication during pregnancy. In this study, women who stopped their medicine were five times more likely to have a relapse of depression during their pregnancy than were women who continued to take their antidepressant medicine while pregnant.
The second study suggests there may be additional, though rare, risks of taking SSRI medications during pregnancy. This study focused on newborn babies with persistent pulmonary hypertension (PPHN), which is a serious and life-threatening lung condition that occurs soon after birth. Babies born with PPHN have high pressure in their lung blood vessels and are not able to get enough oxygen into their bloodstream. In this study, PPHN was six times more common in babies whose mothers took an SSRI antidepressant after the 20th week of pregnancy compared to babies whose mothers did not take an antidepressant. The study was too small to compare the risk of one drug compared to another. The finding of PPHN in babies of mothers who used a SSRI antidepressant in the second half of pregnancy adds to concerns from previous reports that infants of mothers taking SSRIs late in pregnancy may experience difficulties such as irritability, difficulty feeding and in very rare cases, difficulty breathing.
Additionally, the labeling for paroxetine (Paxil) was recently changed to add information about findings in an epidemiologic study that suggests that exposure to the drug in the first trimester of pregnancy may be associated with an increased risk of cardiac birth defects.
Women who are pregnant or thinking about becoming pregnant should not stop any antidepressant medication without first consulting their physician. The FDA is seeking additional information about the possible risk of PPHN in newborn babies of mothers who took SSRI antidepressants in pregnancy. FDA has asked the sponsors of all SSRIs to change prescribing information to describe the potential risk for PPHN.
[July 19, 2006 - Public Health Advisory - FDA]
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- 5-Hydroxytryptamine Receptor Agonists (Triptans)
Selective Serotonin Reuptake Inhibitors (SSRIs)
Selective Serotonin/Norepinephrine Reuptake Inhibitors (SNRIs)
Serotonin Syndrome
- Audience: Neuropsychiatric and other healthcare professionals, and consumers
[Posted 07/19/2006] FDA notified healthcare professionals and consumers of new safety information regarding taking medications used to treat migraine headaches (triptans) together with certain types of antidepressant and mood disorder medications (selective serotonin reuptake inhibitors (SSRIs) and selective serotonin/norepinephrine reuptake inhibitors (SNRIs). A life-threatening condition called serotonin syndrome may occur when triptans are used together with a SSRI or a SNRI.
Serotonin syndrome occurs when the body has too much of a chemical found in the nervous system (serotonin). Each of the above medications (triptans, SSRIs, and SNRIs), cause an increase in serotonin levels. Symptoms of serotonin syndrome may include restlessness, hallucinations, loss of coordination, fast heart beat, rapid changes in blood pressure, increased body temperature, overactive reflexes, nausea, vomiting, and diarrhea.
Healthcare professionals prescribing a triptan, SSRI or SNRI should keep in mind that triptans are often used intermittently and either the triptan, SSRI or SNRI may be prescribed by a different physician; weigh the potential risk of serotonin syndrome with the expected benefit of using the above combination; discuss the possibility of serotonin syndrome with patients if a triptan and an SSRI or SNRI will be used together; and follow patients closely during treatment if a triptan and an SSRI or SNRI are used together.
Patients taking a triptan along with an SSRI or SNRI should talk to their doctor before stopping their medication and should immediately seek medical attention if they experience any of the above symptoms. FDA requested that all manufacturers of triptans, SSRIs and SNRIs update their prescribing information to warn of the possibility of serotonin syndrome when these medications are taken together.
[July 19, 2006 - Public Health Advisory - FDA]
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- Disetronic D-TRONplus Power Packs used in D-TRONplus Insulin Pumps
- Audience: Endocrinologists, other healthcare professionals, and consumers
[UPDATE 09/20/2006] Recall classified as Class I because the potential of the pump's power pack to fail may cause serious adverse health consequences, including death.
[Posted 07/14/2006] Disetronic Medical Systems Inc. (Disetronic) and FDA announced a voluntary nationwide recall of the Disetronic D-TRONplus Power Packs, that power the D-TRONplus Insulin Pump. There is the potential that the power pack could shut down the D-TRONplus Insulin Pump without any warning. If a shut down occurs, insulin delivery is interrupted. An interruption in insulin delivery may lead to uncontrolled diabetes mellitus, resulting in hyperglycemia, which may lead to serious patient injury and/or death.
All pump users must put a new power pack into their insulin pump every two weeks to prevent their pump from turning off without any warning. It is important that this two week period not be extended. Disetronic and their distributors will supply power packs free of charge by UPS next day shipment to all D-TRONplus users until corrective actions have been implemented. Every user will receive a power pack together with detailed instructions.
[September 20, 2006 - Recall Notice - FDA]
[July 13, 2006 - Press Release - Disetronic Medical Systems Inc.]
[July 13, 2006 - Urgent Product Recall - Disetronic Medical Systems Inc.]
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- Azathioprine Tablets, 50 mg
- Audience: Pharmacists and other healthcare professionals
[Posted 07/13/2006] Roxane Laboratories and FDA notified pharmacists and other healthcare professionals of a nationwide recall of a single manufacturing lot of Azathioprine tablets, 50 mg (Lot 558470A, Exp Mar 2009) used to help prevent rejection in kidney transplant patients, and to manage severe rheumatoid arthritis. The recall was initiated due to concerns that bottles from this single lot # 558470A, labeled as Azathioprine may contain Methotrexate, 2.5 mg tablets. Information has been sent to pharmacists alerting them of the details pertaining to this recall. Pharmacists who may have dispensed Azathioprine tablets to patients from manufacturing lot 558470A are instructed to contact those patients to assure they did not inadvertently receive Methotrexate tablets.
[July 13, 2006 – Press Release – Roxane]
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- Dietary Supplements Promoted for Sexual Enhancement
- Audience: Consumers and healthcare professionals
[Posted 07/13/2006] The FDA notified healthcare professionals and consumers of a warning not to purchase or consume Zimaxx, Libidus, Neophase, Nasutra, Vigor-25, Actra-Rx, or 4EVERON, illegal drugs with undeclared ingredients that are promoted and sold on web sites as "dietary supplements" for treating erectile dysfunction and enhancing sexual performance. These products have not been approved by FDA, and there is no guarantee of their safety and effectiveness, or of the purity of their ingredients. They pose a threat to consumers because the undeclared ingredients may interact with nitrates found in some prescription drugs (such as nitroglycerin) and lower blood pressure to dangerous levels. Consumers with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates. FDA advises consumers who have used any of these products to discontinue use and to consult their healthcare provider.
[July 12, 2006 – News Release – FDA]
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- Baxter Healthcare Colleague Volumetric Infusion Pump
Baxter Healthcare Syndeo Patient Controlled Analgesic Syringe Pump
- Audience: Hospital nursing supervisory personnel and risk managers
[UPDATE 02/27/2007] FDA has cleared for marketing a modified Colleague Volumetric Infusion Pump which addresses many of the problems that prompted a series of Class I recalls and a product seizure in 2005. Confusing display screens, software defects, swollen batteries and other defects could have resulted in the pumps either shutting down or under- or over-delivering critical medication and fluids to patients and were associated with serious injuries and deaths.
[Posted 07/07/2006] FDA notified healthcare professionals that Baxter Healthcare will stop manufacturing and distributing all models of Colleague Volumetric Infusion Pump and Syndeo Patient Controlled Analgesic Syringe Pump until the company corrects manufacturing deficiencies and is in compliance with FDA's current good manufacturing practice requirements and the Quality System regulation for devices. FDA will allow the firm to continue to provide routine service maintenance, or to replace components, parts, or accessories for the Colleague and Syndeo Infusion Pumps that were already in the hands of customers before October 12, 2005. The Colleague pump has exhibited a variety of problems, including under-infusion, battery failures, false alarms and failure to alarm. FDA issued a Preliminary Public Health Notification on April 28, 2006 with recommendations for users, http://www.fda.gov/cdrh/safety/042806‑baxter.html.
[February 27, 2007 – News Release – FDA]
[June 29, 2006 – News Release – FDA]
Previous MedWatch Alerts:
[April 28, 2006]
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- Welch Allyn PIC 50 Automated External Defibrillators
- Audience: Emergency services personnel and risk managers
[Posted 07/07/2006] MRL, Inc., and FDA notified healthcare professionals of a Class I recall of Welch Allyn PIC 50 Automated External Defibrillators, catalog #97108X manufactured from March 2002 through October 2004. An electrical contact problem may result in the device's failure to provide a defibrillation shock, that could result in delay or failure to resuscitate the patient. This failure may be accompanied by various error messages on the display panel, including the "Defib Comm" error message.
[June 30, 2006 – Recall Notice – FDA]
Related MedWatch Alerts:
[June 12, 2006] Welch Allyn AED20 Automatic External Defibrillators
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- Aptivus (tipranavir)
- Audience: Infectious disease specialists, pharmacists, and other healthcare professionals
[Posted 06/30/2006] Boehringer Ingelheim and FDA informed healthcare professionals of important new safety information for Aptivus (tipranavir) capsules, co-administered with ritonavir (500mg/200mg), that includes an addition to the drug's Black Box Warning regarding reports of both fatal and non-fatal intracranial hemorrhage (ICH). Boehringer Ingelheim identified 14 reports of intracranial hemorrhage events, including 8 fatalities, in 6,840 HIV-1 infected individuals receiving Aptivus capsules in combination antiretroviral therapy in clinical trials.
Many of the patients experiencing ICH in the Aptivus clinical development program had other medical conditions (CNS lesions, head trauma, recent neurosurgery, coagulopathy, hypertension or alcohol abuse) or were receiving concomitant medications, including anticoagulants and antiplatelet agents, that may have caused or contributed to these events.
No pattern of abnormal coagulation parameters were observed in patients receiving Aptivus in general, or preceding the development of ICH. Routine measurement of coagulation parameters is not currently indicated in the management of patients on Aptivus. An increased risk of ICH was previously observed in patients with advanced HIV-1 disease/AIDS. Further investigations are ongoing to assess the role of Aptivus in ICH.
[June 30, 2006 – Revised Prescribing Information – Boehringer Ingelheim]
[June 30, 2006 – Dear Healthcare Provider Letter – Boehringer Ingelheim]
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- Ketek (telithromycin)
- Audience: Infectious disease, hepatology and other healthcare professionals
[Posted 06/29/2006] The Food and Drug Administration notified healthcare professionals and patients that it completed its safety assessment of Ketek (telithromycin), indicated for the treatment of acute exacerbation of chronic bronchitis, acute bacterial sinusitis and community acquired pneumonia of mild to moderate severity, including pneumonia caused by resistant strep infections. The drug has been associated with rare cases of serious liver injury and liver failure with four reported deaths and one liver transplant after the administration of the drug. FDA determined that additional warnings are required and the manufacturer is revising the drug labeling to address this safety concern. FDA is advising both patients taking Ketek and their doctors to be on the alert for signs and symptoms of liver problems. Patients experiencing such signs or symptoms should discontinue Ketek and seek medical evaluation, which may include tests for liver function.
[June 29, 2006 – News Release – FDA]
Previous MedWatch Alert
[January 20, 2006]
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- Guidant INSIGNIA and NEXUS Pacemakers
Guidant CONTAK RENEWAL TR/TR2 Cardiac Resynchronization Therapy Pacemakers
Guidant VENTAK PRIZM 2, VITALITY and VITALITY 2 Implantable Cardioverter Defibrillators
- Audience: Cardiac healthcare professionals, risk managers and biomedical engineers
[Posted 06/26/2006, UPDATED 07/11/2006] Guidant and FDA notified healthcare professionals and patients that a subset of implantable pacemakers, cardiac resynchronization therapy pacemakers and implantable cardioverter defibrillators [ICDs] is associated with five reports of device malfunction due to the failure of a low-voltage capacitor from a single component supplier. Patients with affected pacemakers may experience intermittent or permanent loss of output or telemetry or premature battery depletion. Patients with affected ICDs may experience inappropriate sensing or premature battery depletion. Physicians are asked to perform an exam as soon as possible to assess device function for all patients with implanted devices from this subset.
[April 10, 2007 - Questions & Answers - FDA]
[July 11, 2006 – FDA Statement – FDA]
[June 26, 2006 – Press Release – Boston Scientific/Guidant]
[June 23, 2006 – Letter to Physicians – Guidant]
[June 23, 2006 – Letter to Patients – Guidant]
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- Sage Products Inc. Comfort Shield Perineal Care Washcloths
- Audience: Hospital and Long-term care facility nursing supervisory staff
[Posted 06/26/2006] Sage Products and FDA notified healthcare professionals of a recall of specific lots of Comfort Shield Perineal Care Washcloths due to contamination with Burkholderia cepacia. Burkholderia cepacia can cause serious infections including pneumonia and bacterial sepsis in immuno-compromised persons, persons with cystic fibrosis, in hospitalized patients in general as well as certain other patient groups. The product was distributed to hospitals, medical centers and long-term care facilities in the U.S. and Canada. There was no known distribution through retail sales.
[June 23, 2006 – Press Release – Sage Products, Inc.]
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- Reprocessing of Reusable Ultrasound Transducer Assemblies Used for Biopsy Procedures
- Audience: Hospital healthcare professionals, surgical center staff, and risk managers
[Posted 06/20/2006] FDA issued a Public Health Notification regarding the
proper cleaning and sterilizing of reusable ultrasound biopsy transducer assemblies (i.e., transducer device and associated accessories). If these devices are not correctly reprocessed between patients, residual material from a previous patient may contaminate the biopsy needle and needle guide when the system is reused for biopsies. This could lead to patient infections.
Therefore, the biopsy needle and its containing guide must always be sterilized. This should apply even if a sterile barrier sheath is used on the transducer assemblies during a biopsy procedure, as the sheath is compromised by the penetration of the needle. The Public Health Notification also provides recommendations for cleaning the devices.
[June 19, 2006 – Public Health Notification – FDA]
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- Triaminic Vapor Patch
- Audience: Pediatricians, other healthcare professionals and consumers
[Posted 06/20/2006] Novartis Consumer Health and FDA notified patients, pharmacists and other healthcare professionals that the sponsor is conducting a nationwide voluntary recall of all Triaminic Vapor Patch products due to reports of serious adverse events associated with accidental ingestion by children. Triaminic Vapor Patch is labeled as a cough suppressant for children two (2) years of age and older and is sold over the counter at pharmacies and retail outlets nationwide. The directions on the label indicate the patch is to be applied to the throat or chest to allow the vapors to reach the nose and mouth. FDA is warning consumers not to use the Triaminic Vapor Patch and is also advising consumers who have used the product and have concerns or questions to contact their physician or health care practitioner.
[June 20, 2006 – Public Health Advisory – FDA]
[June 19, 2006 – Press Release – Novartis]
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- Welch Allyn AED20 Automatic External Defibrillators
- Audience: Emergency Services personnel and risk managers
[Posted 06/16/2006] MRL, Inc. and FDA notified healthcare professionals of a voluntary worldwide Class I recall of 580 AED20 automatic external defibrillators. An intermittent electrical connection within the device may result in failure or unacceptable delay in analyzing the patient's ECG, failure to deliver appropriate therapy and failure to resuscitate the patient. FDA defines a Class I recall as one in which there is reasonable probability that the use of or exposure to the product will cause serious adverse health consequences or death.
[June 15, 2006 - Recall Notice - FDA]
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- Hamilton Medical, Inc. RAPHAEL Ventilators
- Audience: Respiratory healthcare professionals and hospital risk managers
[Posted 06/12/2006] Hamilton Medical, Inc. and FDA notified healthcare professionals of a recall of certain RAPHAEL model ventilators with older generation software, due to a software algorithm designe | |
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