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- Super Shangai, Strong Testis, Shangai Ultra, Shangai Ultra X, Lady Shangai, Shangai Regular (also known as Shangai Chaojimengnan)
- Audience: Consumers, healthcare professionals
[Posted 12/31/2007] FDA notified consumers and healthcare professionals not to buy or use Super Shangai, Strong Testis, Shangai Ultra, Shangai Ultra X, Lady Shangai, and Shangai Regular (also known as Shangai Chaojimengnan) products. The products are marketed as dietary supplements and used for the treatment of erectile dysfunction (ED) and for sexual enhancement. The products do not qualify as dietary supplements because they contain undeclared active ingredients of FDA-approved prescription drugs for ED. The products are thus drugs that are illegal because they lack FDA approval. Additionally, because the manufacturing source of the active ingredients in these products is unknown, consumers should be aware that the safety, efficacy, and purity of the ingredients can not be validated.
The undeclared ingredients in the referenced products may interact with nitrates found in some prescription drugs (such as nitroglycerin) and can lower blood pressure to dangerous levels. Consumers with diabetes, high blood pressure, high cholesterol, or heart disease often take products containing nitrates. Consumers who have these products should discontinue using them and consult their healthcare professional.
[December 28, 2007 - News Release - FDA]
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- Bayer Diabetes Care Contour Test Strips (TS)
- Audience: Endocrinologists, healthcare professionals, diabetic patients, and pharmacies
[Posted 12/26/2007] Bayer Diabetes Care notified healthcare professionals and consumers of a voluntary market recall of test strips (sensors) used exclusively with the Contour TS Blood Glucose Meter. The product was recalled because test strips from specific lots could result in blood glucose readings with a positive bias that could demonstrate 5 - 17% higher test results. This issue is unrelated to the Contour TS meter itself and pertains only to certain test strips used with the meter. There is no impact on the performance of strips with other Bayer meters.
Healthcare professionals, retailers, patients and other customers who use Contour TS are advised to check the lot number of the test strips in their inventory and contact Bayer Diabetes Care for information regarding the return and replacement of strips. See the manufacturer's press release for specific product lot numbers affected by this recall.
[December 21, 2007 - Press Release - Bayer Diabetes Care]
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- Cardinal Health Alaris Pump Module
- Audience: Hospital administrations, hospital risk managers, healthcare professionals
[UPDATE 01/11/2008] FDA informed healthcare professionals that the recall of all Alaris Infusion Pump modules (formerly Medley) shipped prior to September 27, 2007, has been classified as a Class I Recall.
[Posted 12/26/2007] Cardinal Health notified its customers of a voluntary recall for all Alaris Pump modules, model 8100 (formerly known as Medley Pump module), shipped prior to September 27, 2007. The recall covers Alaris Pump modules that were distributed to 46 States, the District of Columbia, Canada, Guam, Puerto Rico and Saudi Arabia. The pump module was recalled because the units may contain misassembled occluder springs (bent, broken, nested or missing) that occurred during manufacturing. Misassembled springs could lead to overinfusion that could result in serious adverse health consequences or death. Overinfusion may be difficult to detect because the misassembled springs can work intermittently, and there is no warning or notification of an overinfusion. See the manufacturer's press release for a list of the serial numbers for the affected devices and how the manufacturer will work with customers to minimize disruption while completing an inspection of the devices.
[January 11, 2008 - Recall Notice - FDA]
[December 26, 2007 - Press Release - Cardinal Health]
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- Heparin Lock Flush Solution (Pre-Filled 5 ml in 12 ml Syringes)
- Audience: Hospital and nursing home administrators, hospital risk managers, pharmacists, other healthcare professionals, consumers
[Posted 12/21/2007] AM2 PAT, Inc., and FDA informed healthcare professionals and consumers of a nationwide recall of one lot of Pre-Filled Heparin Lock Flush Solution (5 ml in 12 mL Syringes), Lot # 070926H. The heparin IV flush syringes were found to be contaminated with Serratia marcescens, which have resulted in patient infections. This type of bacterial infection could present a serious adverse health consequence that could lead to life-threatening injuries and/or death. Consumers and user facilities should immediately stop using the product, quarantine it and return the affected product to the distributor.
[December 20, 2007 - Press Release - AM2 PAT, Inc]
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- Fentanyl Transdermal System (marketed as Duragesic and generics)
- Audience: Pain management specialists, other healthcare professionals
[Posted 12/21/2007] FDA issued an update that highlights important information on appropriate prescribing, dose selection, and the safe use of the fentanyl transdermal system (patch). FDA previously issued a Public Health Advisory and Information for Healthcare Professionals in July 2005 regarding the appropriate and safe use of the transdermal system. However, the Agency continues to receive reports of death and life-threatening adverse events related to fentanyl overdose that have occurred when the fentanyl patch was used to treat pain in opioid-naive patients and when opioid-tolerant patients have applied more patches than prescribed, changed the patch too frequently, and exposed the patch to a heat source. The fentanyl patch is only indicated for use in patients with persistent, moderate to severe chronic pain who have been taking a regular, daily, around-the-clock narcotic pain medicine for longer than a week and are considered to be opioid-tolerant.
Patients must avoid exposing the patch to excessive heat as this promotes the release of fentanyl from the patch and increases the absorption of fentanyl through the skin which can result in fatal overdose. Directions for prescribing and using the fentanyl patch must be followed exactly to prevent death or other serious side effects from fentanyl overdose.
[December 21, 2007 - Public Health Advisory - FDA]
[December 21, 2007 - Information for Healthcare Professionals - FDA]
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- Nonoxynol 9 (N9) OTC Contraceptive Products
- Audience: Consumers, healthcare professionals
[Posted 12/18/2007] FDA issued a final rule that requires that manufacturers of over-the-counter stand-alone vaginal contraceptive and spermicidal products containing the chemical ingredient nonoxynol 9 (N9) include a warning that the chemical N9 does not provide protection against infection from HIV (the virus that causes AIDS) or other sexually transmitted diseases (STDs). Stand-alone spermicides include gels, foams, films, or inserts containing N9 that are used by themselves for contraception. Additionally, the chemical N9 in stand-alone vaginal contraceptives and spermicides can irritate the vagina and rectum, which may increase the risk of contracting HIV/AIDS from an infected partner. Consumers can protect themselves from the transmission of STDs and HIV by practicing abstinence, being in a monogamous relationship where neither partner is infected, and using condoms consistently and correctly.
[December 18, 2007 - News Release - FDA]
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- PedvaxHIB [Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate)] COMVAX [Haemophilus b Conjugate (Menigococcal Protein Conjugate) and Hepatitis B (Recombinant) Vaccine]
- Audience: Pediatricians, family practitioners, other health professionals, consumers
[Posted 12/14/2007] Merck & Co. and FDA informed healthcare professionals and consumers of a voluntary recall of eleven lots of PedvaxHIB and two lots of COMVAX vaccines. The vaccines were recalled because the manufacturer cannot assure sterility of the affected lots. Routine testing of the vaccine manufacturing equipment used to produce PedvaxHIB and COMVAX identified the presence of Bacillus cereus bacteria. Sterility tests of the vaccine lots themselves have not found any contamination. The affected doses were distributed in the U.S. starting in April 2007. Healthcare professionals should immediately discontinue use of any of the affected lots and follow the manufacturer's instructions for returning recalled vaccines. See the FDA Consumer Update for a list of the specific lots of each vaccine recalled.
[December 13, 2007 - FDA Consumer Update - FDA]
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- Electric Dental Handpieces
- Audience: Dentists, Oral Surgeons, dental hygienists, other healthcare professionals
[Posted 12/13/2007] FDA informed healthcare professionals about serious patient injuries, including third degree burns, associated with the use of poorly maintained electric dental handpieces during dental procedures. Some patients had third degree burns which required plastic surgery. Burns may not be apparent to the operator or the patient until after the tissue damage occurred, because the anesthetized patient cannot feel the tissue burning and the handpiece housing insulates the operator from the heated attachment. Although the reported burns occurred during the cutting of tooth and bone, tooth extraction and other dental surgical procedures, overheating can also occur during any dental procedure. This problem is not limited to dentistry. Rotary surgical handpieces can cause patient burns during orthopedic procedures, as reported in the July 2003 edition of FDA Patient Safety News (http://www.fda.gov/cdrh/psn/show17-burns.html). Read the FDA Public Health Notification for specific actions to prevent or minimize serious patient injuries associated with using electric dental handpieces.
[December 12, 2007 - Public Health Notification - FDA]
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- Radio Frequency Ablation Devices
- Audience: Thoracic Surgeons, hospital administrators, other healthcare professionals
[UPDATE 09/26/2008] FDA issued a clarification to the December 11, 2007 Public Health Notification. The clarification discusses the regulatory status of radiofrequency (RF) ablation devices used to treat lung tumors, the regulatory basis for FDA’s clearance of these devices for the indication of general soft tissue ablation, and the public health concerns related to the specific use of RF ablation to treat lung tumors.
[Posted 12/12/2007] FDA alerted healthcare professionals of reports of patient deaths associated with the use of radio frequency (RF) ablation devices during lung tumor ablation. Patient selection, subsequent treatment, and technical use of the RF device, including placement and operation, may have contributed to the fatalities. While RF ablation devices have been cleared for general indications- ablation of soft tissue by thermal coagulation necrosis- the devices have not been cleared specifically for lung tumor ablation. Healthcare professionals should use caution when operating RF ablation devices, adhering strictly to information contained in the labeled operating instructions, Operators Manual, the Manufacturer's Instructions for Use and any training provided. Additionally, if healthcare professionals plan to use RF ablation devices to treat patients with lung tumors, they should consider enrolling patients in an approved clinical study, where training is available.
[September 24, 2008 - Public Health Notification - FDA]
[December 11, 2007 - Public Health Notification - FDA]
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- Carbamazepine (marketed as Carbatrol, Equetro, Tegretol and generics)
- Audience: Neurologists, psychiatrists, other healthcare professionals, consumers
[Posted 12/12/2007] FDA informed healthcare professionals that dangerous or even fatal skin reactions (Stevens Johnson syndrome and toxic epidermal necrolysis), that can be caused by carbamazepine therapy, are significantly more common in patients with a particular human leukocyte antigen (HLA) allele, HLA-B*1502. This allele occurs almost exclusively in patients with ancestry across broad areas of Asia, including South Asian Indians. Patients with ancestry from areas in which HLA-B*1502 is present should be screened for the HLA-B*1502 allele before starting treatment with carbamazepine. If these individuals test positive, carbamazepine should not be started unless the expected benefit clearly outweighs the increased risk of serious skin reactions. Patients who have been taking carbamazepine for more than a few months without developing skin reactions are at low risk of these events ever developing from carbamazepine. This is true for patients of any ethnicity or genotype, including patients positive for HLA-B*1502.
[December 12, 2007 - Information for Healthcare Professionals - FDA]
[December 12, 2007 - Drug Information Page - FDA]
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- Vail Products Enclosed Bed Systems
- Audience: Hospital and Extended Care Facility Administrators, Risk Managers, consumers
[Posted 12/04/2007] FDA provided final recommendations for users of Vail Enclosed Bed Systems that updates the Agency's 2005 Preliminary Public Health Notification. Users of the bed systems were warned that the bed poses a health risk because patients can become entrapped in them and suffocate. Because of the suffocation risk, FDA advises hospitals, nursing homes and consumers who have a Vail enclosed bed system to stop using it and move the patient to an alternate bed. Consumers who are using Vail beds at home should consult with their physicians about other options. See the Public Health Notification for safety precautions recommended by the manufacturer if continued use of the Vail bed is the only option.
[December 04, 2007 - Public Health Notification - FDA]
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- Desmopressin Acetate (marketed as DDAVP Nasal Spray, DDAVP Rhinal Tube, DDAVP, DDVP, Minirin, and Stimate Nasal Spray)
- Audience: Endocrinologists, pediatricians, other healthcare professionals
[UPDATE 8/07/2008] The Dear Healthcare Professional Letter issued by Sanofi-aventis U.S. in December 2007 has been added as a link below. Also, links to prescribing information for healthcare professionals and patient package labeling with the safety-related revisions highlighted are included for the following DDAVP (desmopressin acetate) Sanofi-aventis, U.S. products: Nasal Spray, Rhinal Tube, Injection, and Tablets.
[Posted 12/04/2007] FDA notified healthcare professionals and patients of the Agency's request that manufacturers update the prescribing information for desmopressin to include important new safety information about severe hyponatremia and seizures. Certain patients, including children treated with the intranasal formulation of the drug for primary nocturnal enuresis (PNE), are at risk for developing severe hyponatremia that can result in seizures and death. As such, desmopressin intranasal formulations are no longer indicated for the treatment of primary nocturnal enuresis and should not be used in hyponatremic patients or patients with a history of hyponatremia. PNE treatment with desmopressin tablets should be interrupted during acute illnesses that may lead to fluid and/or electrolyte imbalance. All desmopressin formulations should be used cautiously in patients at risk for water intoxication with hyponatremia.
[December 04, 2007 - Information for Healthcare Professionals - FDA]
[December 2007 - Dear Healthcare Professional Letter - Sanofi-Aventis] 
[October 2007 - DDAVP Injection - Label - Sanofi-Aventis]
[October 2007 - DDAVP Nasal Spray - Label and PPI - Sanofi-Aventis]
[October 2007 - DDAVP Rhinal Tube - Label and PPI - Sanofi-Aventis]
[October 2007 - DDAVP Tablets - Label - Sanofi-Aventis]
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- Myfortic (mycophenolic acid) Delayed-Release Tablets
- Audience: Oncologists, OB/GYN physicians, other healthcare professionals, patients
[Posted 11/27/2007] Novartis and FDA informed healthcare professionals and patients that use of Myfortic Delayed- Release Tablets during pregnancy is associated with increased risks of pregnancy loss and congenital malformations. The pregnancy category for Myfortic has been changed to Category D (Positive evidence of fetal risk). This change is a result of postmarketing data from the United States National Transplantation Pregnancy Registry and additional postmarketing data collected in women exposed to systemic mycophenolate mofetil (MMF) during pregnancy. MMF is converted to the active ingredient in Myfortic, following oral or intravenous administration.
A patient who is planning a pregnancy should not use Myfortic unless she cannot be successfully treated with other immunosuppressant drugs. Healthcare professionals should discuss the risks and benefits of Myfortic as well as alternative immunosuppressant therapy with the patient. Female patients of childbearing potential must receive contraceptive counseling and must use effective contraception while taking Myfortic. Myfortic is indicated for the prophylaxis of organ rejection in patients receiving allogeneic renal transplants, administered in combination with cyclosporine and corticosteroids.
[November 2007 - Dear Healthcare Professional letter - Novartis]
[October 2007 - Label - Novartis]
Previous MedWatch Alert:
[10/29/2007]
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- Encore Supplement Tablets
- Audience: Healthcare professionals, consumers
[Posted 11/26/2007] Bodee LLC and FDA notified consumers and healthcare professionals of a nationwide recall of Encore Tablets, a dietary supplement sold in health food stores, via the internet and by mail order nationwide and in Canada. The product was recalled because it contains potentially harmful, undeclared ingredients. One lot of the product contained aminotadalafil, an analog of tadalafil, the active ingredient of a FDA-approved drug used for Erectile Dysfunction. The undeclared chemical poses a threat to consumers because it may interact with nitrates found in some prescription drugs (such as nitroglycerin) and may lower blood pressure to dangerous levels.
Consumers who have this product should stop using it immediately and contact their physician if they have experienced any problems that may be related to taking this product.
[November 21, 2007 - Press Release - Bodee LLC]
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- Chantix (varenicline)
- Audience: Healthcare professionals, consumers
[UPDATE 05/16/2008] FDA informed healthcare professionals and patients that as the Agency’s review of Chantix safety data has progressed, it appears increasingly likely that there is an association between Chantix and serious neuropsychiatric symptoms. Prescribing information for Chantix was revised to include this safety information in the WARNINGS and PRECAUTIONS sections of the label, and a Medication Guide for patients is also available. If patients, their families, or caregivers notice agitation, depressed mood, or changes in behavior that are not typical for the patient or if the patient has suicidal thoughts or actions, the patient should stop taking Chantix and contact their healthcare professional.
[Posted 11/20/2007] FDA informed healthcare professionals of reports of suicidal thoughts and aggressive and erratic behavior in patient who have taken Chantix, a smoking cessation product. There are also reports of patients experiencing drowsiness that affected their ability to drive or operate machinery. FDA is currently reviewing these cases, along with other recent reports. A preliminary assessment reveals that many of the cases reflect new-onset of depressed mood, suicidal ideation, and changes in emotion and behavior within days to weeks of initiating Chantix treatment. The role of Chantix in these cases is not clear because smoking cessation, with or without treatment, is associated with nicotine withdrawal symptoms and has also been associated with the exacerbation of underlying psychiatric illness. However, not all patients described in the cases had preexisting psychiatric illness and not all had discontinued smoking.
Healthcare professionals should monitor patients taking Chantix for behavior and mood changes. Patients taking this product should report behavior or mood changes to their doctor and use caution when driving or operating machinery until they know how quitting smoking with Chantix may affect them.
[May 2008 - Label - Pfizer]
[May 16, 2008 - Drug Information Page - FDA]
[May 16, 2008 - Medication Guide - Pfizer]
[May 16, 2008 - Information for Healthcare Professionals sheet - FDA]
[November 20, 2007 - Ongoing Safety Review: Varenicline (marketed as Chantix) - FDA]
[November 2007 - Prescribing Information - Pfizer]
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- Age Intervention Eyelash
- Audience: Ophthalmologists, dermatologists, estheticians, consumers
[Posted 11/19/2007] FDA informed healthcare professionals and consumers of the seizure of 12,682 applicator tubes of Age Intervention Eyelash, sold and distributed by Jan Marini Skin Research, Inc. of San Jose, California. The product was seized because it may lead to decreased vision in some users. The eyelash product is an unapproved and misbranded drug because it is promoted to increase eyelash growth. Before a new drug product may legally be marketed, it must be shown to be safe and effective, and approved by FDA. FDA considers the product to be an adulterated cosmetic because it contains bimatoprost, an active ingredient in an FDA-approved drug to treat elevated intraocular pressure (elevated pressure inside the eye). Use of the prescription drug in addition to the eyelash product containing the drug, may increase the risk of optic nerve damage because the extra dose of bimatoprost may decrease the prescription drug's effectiveness. Damage to the optic nerve may lead to deceased vision and possibly blindness. Other possible adverse events may include macular edema (swelling of the retina) and uveitis (inflammation in the eye) which may lead to decreased vision.
Dermatologists, estheticians, and consumers who may still have Age Intervention Eyelash should discontinue use and discard any remaining product. Consumers should also consult their healthcare professional if they have experienced any adverse events that they suspect are related to use of the product.
[November 16, 2007 - News Release - FDA]
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- Thoratec Implantable Ventricular Assist Devices
- Audience: Cardiologists, hospital risk managers, patients
[Posted 11/16/2007] Thoratec Corporation and FDA notified healthcare professionals and patients of a Class I Recall of Thoratec Implantable Ventricular Assist Devices (IVADs), serial numbers 488 and higher (located on the label of the sterile package and on the driveline’s Y-connector), manufactured and distributed from October 1, 2004 through October 22, 2007. The device is a mechanical air-driven (pneumatic) pump that helps a person's heart that is too weak to pump blood through the body. The current instructions for use state that IVADs may be implanted or placed in the external position. If the IVAD is placed in the external position, air leaks may develop in the pneumatic driveline that could result in not enough blood flow to and from the heart. This recall does not affect implanted IVADs. Physicians should contact their patients if any Thoratec IVAD was placed in the external position and patients should contact their physicians with any questions.
[November 16, 2007 - Recall Notice - FDA]
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- Avandia (rosiglitazone maleate) Tablets
- Audience: Cardiologists, endocrinologists, other healthcare professionals, consumers
[UPDATE 11/19/2007] Information for Healthcare Professionals Sheet highlights changes to the prescribing information for rosiglitazone, including a new BOXED WARNING and changes to the WARNINGS, PRECAUTIONS, and INDICATIONS sections of the product's prescribing information about the potential increased risk of myocardial ischemia.
[Posted 11/14/2007] FDA informed healthcare professionals of new information added to the existing boxed warning in Avandia's prescribing information about potential increased risk for heart attacks. The new information refers to a meta-analysis of 42 clinical studies, most of which compared Avandia to placebo, that showed Avandia to be associated with an increased risk of myocardial ischemic events such as angina or myocardial infarction. At this time, FDA has concluded that there isn't enough evidence to indicate that the risks of heart attacks or death are different between Avandia and some other oral type 2 diabetes treatments. People with type 2 diabetes who have underlying heart disease or who are at high risk of heart attack should talk to their healthcare professional about the revised warning as they evaluate treatment options. Healthcare professionals are advised to closely monitor patients who take Avandia for cardiovascular risks.
[November 19, 2007 - Information for Healthcare Professionals - FDA]
[November 14, 2007 - News Release - FDA]
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- Cefepime (marketed as Maxipime)
- Audience: Healthcare professionals
[UPDATE 05/14/2008] FDA is continuing its investigation of a possible association between the use of cefepime and an increased risk of mortality compared with similar drugs. FDA will communicate its conclusions and any resulting recommendations to the public at the completion of its review.
[Posted 11/14/2007] FDA issued an early communication about the ongoing review of new safety data and the request for additional data to further evaluate the risk of death in patients treated with cefepime. An article in the May 2007 issue of The Lancet Infectious Diseases (Efficacy and safety of cefepime: a systematic review and meta-analysis) raised the question about increased mortality with the use of cefepime, a broad spectrum B-lactam antibiotic currently approved for the treatment of a variety of infections due to susceptible strains of microorganisms. The article describes a higher all-cause mortality in patients treated with cefepime compared to other B-lactam antibiotics. Until FDA's evaluation is completed, healthcare professionals who are considering the use of cefepime should be aware of the risks and benefits described in the product's prescribing information and the new information from this meta-analysis.
[May 14, 2008 - Update of Safety Review - FDA]
[November 14, 2007 - Ongoing Safety Review: Cefepime - FDA]
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- Erythropoiesis Stimulating Agents:
Aranesp (darbepoetin alfa), Epogen (epoetin alfa), and Procrit (epoetin alfa)
- Audience: Oncologists, nephrologists, other healthcare professionals
[UPDATE 01/03/2008] FDA informed healthcare professionals of findings from two additional clinical studies, Preoperative Epirubicin Paclitaxel Aranesp Study (PREPARE), and the National Cancer Institute Gynecologic Oncology Group (COG-19), showing an increase in mortality and shorter time to tumor progression in patients with cancer receiving an Erythropoiesis-Stimulating Agent (ESA). Both the PREPARE study in breast cancer and the COG-19 study in cervical cancer showed higher rates of death and or tumor progression in patients who received an ESA compared to patients who did not receive an ESA. FDA strongly recommends that healthcare professionals discuss the risks of ESA-associated tumor progression and shortened survival in patients with cancer before starting or continuing ESA therapy.
[Posted 11/08/2007] FDA notified healthcare professionals of revised boxed warnings and other safety-related product labeling changes for erythropoiesis-stimulating agents (ESAs), which treat certain types of anemia. These new statements address the risks that the drugs Aranesp, Epogen, and Procrit pose to patients with cancer and patients with chronic kidney failure. For patients with cancer, the new boxed warnings emphasize that ESAs caused tumor growth and shortened survival in patients with advanced breast, head and neck, lymphoid and non-small cell lung cancer when they received a dose that attempted to achieve a hemoglobin level of 12 grams per deciliter (g/dL) or greater. For patients with chronic kidney failure, the new boxed warning states that ESAs should be used to maintain a hemoglobin level between 10 g/dL to 12 g/dL. Maintaining higher hemoglobin levels in patients with chronic kidney failure increases the risk of death and other serious conditions. The new labeling provides specific instructions for dosage adjustments and hemoglobin monitoring for chronic kidney failure patients who do not respond to ESA treatment with an adequate increase in their hemoglobin levels.
Additionally, the new boxed warnings clarify that ESAs should only be used in patients with cancer when treating anemia specifically caused by chemotherapy and not for other causes of anemia. Further, it states that ESAs should be discontinued once the patient's chemotherapy course has been completed.
[January 03, 2008 - Communication about an Ongoing Safety Review - FDA]
[November 08, 2007 - Labels for Epogen, Procit - FDA]
[November 08, 2007 - Label for Aranesp - FDA]
[November 08, 2007 - Drug Information Page - FDA]
Previous MedWatch Alerts:
[February 16, 2007]
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- Trasylol (aprotinin injection)
- Audience: Cardiac surgeons and other healthcare professionals
[UPDATE 05/14/2008] Following publication of the Blood conservation using antifibrinolytics: A randomized trial in a cardiac surgery population (BART) study in the May 14, 2008 online issue of The New England Journal of Medicine, Bayer Pharmaceuticals notified the FDA of their intent to remove all remaining supplies of Trasylol from hospital pharmacies and warehouses. Under a limited use agreement, access to Trasylol is limited to investigational use of the drug according to the procedures described in a special treatment protocol. The protocol allows treatment for certain patients who are at increased risk of blood loss and transfusions during coronary artery bypass graft surgery and who have no acceptable alternative therapy. Physicians using Trasylol in this situation must also verify that the benefits of the drug clearly outweigh the risks for their patients.
[Posted 11/05/2007] FDA announced that, at the agency's request, Bayer Pharmaceuticals Corp. has agreed to a marketing suspension of Trasylol (aprotinin injection), a drug used to control bleeding during heart surgery, pending detailed review of preliminary results from a Canadian study that suggested an increased risk for death. FDA requested the suspension in the interest of patient safety based on the serious nature of the outcomes suggested in the preliminary data. FDA has not yet received full study data but expects to act quickly with Bayer, the study's researchers at the Ottawa Health Research Institute, and other regulatory agencies to undertake a thorough analysis of data to better understand the risks and benefits of Trasylol.
Until FDA can review the data from the terminated study it is not possible to determine and identify a population of patients undergoing cardiac surgery for which the benefits of Trasylol outweigh the risks. However, understanding that individual doctors may identify specific cases where benefit outweighs risk, FDA is committed to exploring ways for those doctors to have continued, limited access to Trasylol. There are not many treatment options for patients at risk for excessive bleeding during cardiac surgery. Thus, FDA is working with Bayer to phase Trasylol out of the marketplace in a way that does not cause shortages of other drugs used for this purpose.
[May 14, 2008 - Drug Information Page - FDA]
[May 14, 2008 - FDA News - FDA]
[November 5, 2007 - FDA News - FDA]
Previous MedWatch Alert:
[October 25, 2007]
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- Welch Allyn AED 10 Automatic External Defibrillators
- Audience: Emergency services personnel, risk managers, and consumers
[UPDATE 11/28/2007] Recall expanded to include Welch Allyn AED 10™ Automatic External Defibrillators, manufactured between March 29, 2007 and August 9, 2007, part numbers 970302E, 970308E, 970309E, 970310E, and 970311E.
[Posted 11/05/2007] FDA issued a Class I recall for Welch Allyn AED 10 Automatic External Defibrillators manufactured between March 29, 2007 and August 9, 2007, part numbers 970302E, 970308E, 970310E, and 970311E. These devices are used by emergency or medical personnel, or by others who have taken the appropriate training in cardiopulmonary arrest (heart attack). They analyze an unconscious patient's heart rhythm and automatically deliver an electrical shock to the heart if needed to restore normal heart rhythm.
There is a possibility that these recalled devices may experience failure or unacceptable delay in analyzing a patient’s ECG resulting in possible failure to deliver the appropriate therapy. The possible failure or delay depends on the location of the defective part that stores an electrical charge on the circuit board. The company plans to replace all affected units and has set up a call center for customers.
[November 02, 2007 - Recall Notice - FDA]
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- Cleaners and Disinfectants: Hazards of Excess Use on Electronic Medical Equipment
- Audience: Hospital Administrators, risk managers, other healthcare professionals
[Posted 11/01/2007] FDA, Centers for Disease Control and Prevention, Environmental Protection Agency, and the Occupational Safety and Health Administration issued a Public Health Notification, "Avoiding Hazards with Using Cleaners and Disinfectants on Electronic Medical Equipment". The notification describes the hazards of using excess cleaning and disinfecting liquids on certain electronic medical equipment and recommends ways to avoid these hazards. The problems included equipment fires and other damage, equipment malfunctions, and healthcare worker burns. Refer to the link below for recommendations on how to avoid hazards and appropriate equipment management.
[November 01, 2007 - Public Health Notification - FDA]
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- NC Solution (antifungal product)
- Audience: Healthcare professionals, consumers
[Posted 11/01/2007] FDA notified healthcare professionals of the seizure of more than $300,000 worth of product, including NC Solution, an antifungal product, and other drugs for human or animal use, dietary supplements, and ingredients to make those products because some lacked FDA approval and all were maintained under grossly unsanitary conditions by General Therapeutics Corp., of St. Louis, Mo. NC Solution is considered a drug because it is intended for use in the diagnosis, cure, or treatment of disease in people or animals and is not generally recognized as safe and effective for its intended uses. The company does not have FDA approval for NC Solution.
Consumers who have any products manufactured by General Therapeutics, including NC Solution, should consult their healthcare provider about discontinuing their use and report if they have experienced any adverse events that they suspect are related to the use of these products.
[November 01, 2007 - News Release - FDA]
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- CellCept (mycophenolate mofetil)
- Audience: Cardiac, renal, hepatic transplantation specialists, gynecologists, obstetricians, and other healthcare professionals
[UPDATE 11/27/2007] Prescribing information for Mycophenolic Acid (marketed as Myfortic Delayed Released Tablets) revised to include information that use of drug during pregnancy is associated with increased risks of pregnancy loss and congenital malformations. See the MedWatch alert for Myfortic (mycophenolic acid).
[Posted 10/29/2007] Roche and FDA notified healthcare providers that use of CellCept (mycophenolate mofetil) is associated with increased risk of first trimester pregnancy loss and increased risk of congenital malformations, especially external ear and facial abnormalities including cleft lip and palate, and anomalies of the distal limbs, heart, esophagus, and kidney. Based on postmarketing data from the United States National Transplantation Pregnancy Registry and additional postmarketing data collected in women exposed to systemic mycophenolate mofetil during pregnancy, the pregnancy category for CellCept has been changed from Category C (risk of fetal harm cannot be ruled out) to Category D (positive evidence of fetal risk). Labeling changes include the following sections: BOXED WARNING, WARNINGS/Pregnancy and Pregnancy Exposure Prevention, PRECAUTIONS/Information for Patients, and ADVERSE REACTIONS/Postmarketing Experience.
Within one week of beginning CellCept therapy, women of childbearing potential should have a negative serum or urine pregnancy test. In addition, women of childbearing potential (including pubertal girls and peri-menopausal woman) taking CellCept must receive contraceptive counseling and use effective contraception. Healthcare professionals and patients should be aware that CellCept reduces blood levels of the hormones in the oral contraceptive pill and could theoretically reduce its effectiveness. See the Dear Healthcare Professional Letter for additional recommendations for women of childbearing potential.
[October 2007 - Myfortic Label - Novartis]
[October 2007 - Letter - Roche]
[September 2007 - Label - Roche]
Previous MedWatch Alert:
[February 22, 2007]
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- Aprotinin Injection (marketed as Trasylol)
- Audience: Cardiac surgeons, other healthcare professionals
[Posted 10/25/2007] FDA informed healthcare professionals of the Data Safety Monitoring Board's recommendation to stop patient enrollment in the aprotinin treatment group arm of the Blood conservation using antifibrinolytics: A randomized trial in a cardiac surgery population (BART) study. The BART study was designed to test the hypothesis that aprotinin was superior to epsilon-aminocaproic acid and tranexamic acid in decreasing the occurrence of massive bleeding in association with cardiac surgery. The preliminary findings suggest that, compared to the antifibrinolytic drugs, epsilon-aminocaproic acid and tranexamic acid, aprotinin increases the risk of death.
FDA anticipates re-evaluation of the overall risks and benefits of Trasylol which may result in the need to revise the prescribing information or other regulatory actions. Healthcare professionals who are considering use of Trasylol should be aware of the risks and benefits described in the prescribing information for Trasylol and the accumulating data suggesting Trasylol administration increases the risk of death compared to other antifibrinolytic drugs.
[October 25, 2007 - Early Communication - FDA]
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-
- Provigil (modafinil) Tablets
- Audience: Neuropsychiatric specialists, other healthcare professionals, consumers
[Posted 10/24/2007] FDA and Cephalon notified healthcare professionals of updates to the WARNINGS section of the prescribing information for Provigil (modafinil). Provigil is indicated to improve wakefulness in adult patients with excessive sleepiness associated with narcolepsy, obstructive sleep apnea/hypopnea syndrome, and shift work sleep disorder. The revised labeling updates safety information to include warnings regarding serious rash, including Stevens-Johnson Syndrome (SJS) and hypersensitivity reactions, and psychiatric symptoms. Rare cases of serious or life-threatening rash, including Toxic Epidermal Necrolysis, and Drug Rash with Eosinophilia and Systemic Symptoms have been reported in adults and children in worldwide postmarketing experience. Angioedema and multi-organ hypersensitivity reactions have also been reported in postmarketing experience.
Physicians should instruct their patients to immediately discontinue the use of Provigil and contact them if a rash or other hypersensitivity reaction occurs. Healthcare professionals and consumers should also be aware that Provigil is not approved for use in pediatric patients for any indication. In addition, psychiatric adverse experiences (including anxiety, mania, hallucinations, and suicidal ideation) have been reported in patients treated with Provigil. Caution should be exercised when Provigil is given to patients with a history of psychosis, depression, or mania.
Additional labeling revisions were made to the CLINICAL PHARMACOLOGY, PRECAUTIONS, and PATIENT PACKAGE INSERT sections. See revised labeling below.
[September 2007 - Dear Healthcare Professional Letter - Cephalon]
[August 2007 - Label - Cephalon]
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-
- Viagra (sildenafil), Cialis (tadalafil), Levitra (vardenafil), Revatio (sildenafil)
- Audience: Urologists, other healthcare professionals, consumers
[Posted 10/18/2007] FDA informed healthcare professionals of reports of sudden decreases or loss of hearing following the use of PDE5 inhibitors Viagra, Levitra, Cialis for the treatment of erectile dysfunction, and Revatio for the treatment of pulmonary arterial hypertension. In some cases, the sudden hearing loss was accompanied by tinnitus and dizziness. Medical follow-up on these reports was often limited which makes it difficult to determine if the loss of hearing was related to the use of one of the drugs, an underlying medical condition or other risk factors for hearing loss, a combination of these factors or other factors. The PRECAUTIONS and ADVERSE REACTIONS sections of the approved product labeling for Viagra, Levitra, and Cialis were revised. FDA is working with the manufacturer to revise the labeling for Revatio.
[October 18, 2007 - Viagra Information page - FDA]
[October 18, 2007 - Viagra label - Pfizer]
[October 18, 2007 - Cialis Information page - FDA]
[October 18, 2007 - Cialis label - FDA]
[October 18, 2007 - Levitra Information page - FDA]
[October 18, 2007 - Levitra label - FDA]
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-
- Byetta (exenatide)
- Audience: Endocrinologists, other healthcare professionals, consumers
[UPDATED 08/18/2008] Since issuing Information
for Healthcare Professionals in October 2007, FDA has received reports of 6 cases of hemorrhagic or necrotizing
pancreatitis in patients taking Byetta. Byetta is a medicine given by subcutaneous
injection to help treat adults with type 2 diabetes. Of the 6 cases of hemorrhagic
or necrotizing pancreatitis, all patients required hospitalization, two
patients died and four patients were recovering at time of reporting. Byetta
was discontinued in all 6 cases. Byetta and other potentially suspect drugs should be promptly discontinued
if pancreatitis is suspected. There are no signs or symptoms that distinguish
acute hemorrhagic or necrotizing pancreatitis associated with Byetta from
the less severe form of pancreatitis. If pancreatitis is confirmed, initiate
appropriate treatment and carefully monitor the patient until recovery.
Byetta should not be restarted. Consider antidiabetic therapies other than
Byetta in patients with a history of pancreatitis.
[UPDATED 02/27/2008] Dear Healthcare Professional letter posted.
[Posted 10/16/2007] FDA has reviewed 30 postmarketing reports of acute pancreatitis in patients taking Byetta (exenatide), a drug used to treat adults with type 2 diabetes. An association between Byetta and acute pancreatitis is suspected in some of these cases. Amylin Pharmaceuticals, Inc. has agreed to include information about acute pancreatitis in the PRECAUTIONS section of the product label.
Healthcare professionals should be alert to the signs and symptoms of acute pancreatitis and instruct patients taking Byetta to seek prompt medical care if they experience unexplained, persistent, severe abdominal pain which may or may not be accompanied by vomiting. If pancreatitis is suspected, Byetta should be discontinued. If pancreatitis is confirmed, Byetta should not be restarted unless an alternative etiology is identified.
[January, 2008 - Label - Amylin
Pharmaceuticals, Inc.]
[October 16, 2007 - Information for Healthcare Professionals - FDA]
[October, 2007 - Letter - Amylin Pharmaceuticals, Inc. and Eli Lilly and Company]
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-
- Medtronic Sprint Fidelis Defibrillator Leads
- Audience: Cardiologists, emergency services personnel, risk managers, consumers
[UPDATED 10/17/2007] FDA issued a Class I Recall of Medtronic Inc. Sprint Fidelis Defibrillator Leads, model numbers 6930, 6931, 6948 and 6949 manufactured from September 2004 through October 15, 2007. Patients who are implanted with this lead, or do not know the model of their lead, should contact their physicians for further information.
[Posted 10/16/2007] FDA issued a statement announcing Medtronic's decision to voluntarily suspend distribution of its Sprint Fidelis defibrillation leads because a small number of fractures have been detected. As a result of Medtronic’s action, no more Sprint Fidelis leads will be sold or manufactured and any remaining product should be pulled from inventory and returned to the company.
When a defibrillator lead is slightly more prone to fracture, most leads will function well, as is the case with Sprint Fidelis. In the infrequent circumstance where a lead actually breaks, or "fractures," the lead may send false signals that cause inappropriate defibrillator shocks, or therapies such as pacing or shocks may not be delivered.
Current adverse event information indicates that fractures have occurred in less than 1 percent of the approximately 268,000 of these leads implanted worldwide. Patients who are implanted with this lead are encouraged to contact their physicians for further information.
[October 17, 2007 - Recall Notice - FDA]
[October 15, 2007 - FDA Statement - FDA]
[October 15, 2007 - Consumer Q&As - FDA]
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-
- Charantea Ampalaya Capsules and Charantea Ampalaya Tea by FullLife Natural Options, Inc.
- Audience: Consumers, healthcare professionals
[Posted 10/15/2007] U.S. Marshals seized approximately $71,000 of goods from FulLife Natural Options, Inc., which marketed and distributed Charantea Ampalaya Capsules and Charantea Ampalaya Tea. Although these products are labeled as dietary supplements, they are being promoted by FulLife for use in treating serious conditions, such as diabetes, anemia, and hypertension. These claims are evident in the products’ labeling, including promotional literature and FulLife’s Internet Web site.
FDA considers these products to be unapproved new drugs because they make claims related to the prevention or treatment of diseases in the products’ labeling. Before a new drug product may be legally marketed, it must be shown to be safe and effective, and approved by FDA. This action protects consumers who may rely on unapproved products and unsubstantiated claims associated with these products when making important decisions about their health.
[October 12, 2007 - Press Release - FDA]
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-
- Micro-bubble Contrast Agents (marketed as Definity (Perflutren Lipid Microsphere) Injectable Suspension and Optison (Perflutren Protein-Type A Microspheres for Injection)
- Audience: Radiologists, radiology technicians, cardiologists, other healthcare professionals
[Posted 10/12/2007] FDA has received reports of deaths and serious cardiopulmonary reactions following the administration of ultrasound micro-bubble contrast agents used in echocardiography. Four of the 11 reported deaths were caused by cardiac arrest occurring either during infusion or within 30 minutes following the administration of the contrast agent; most of the serious but non-fatal reactions also occurred in this time frame. As a result, the manufacturers of Definity and Optison have agreed to revise the labeling for these products in order to optimize their safe use.
Revised labeling includes changes to the following sections: BOXED WARNING, CONTRAINDICATIONS, WARNINGS, and a statement in the INDICATIONS section cautioning that the safety and efficacy of the use of Definity with exercise or pharmacological stress testing have not been established. Together these labeling changes emphasize the risk for serious cardiopulmonary reactions, and that the use of these products is contraindicated in patients with unstable cardiopulmonary status, including patients with unstable angina, acute myocardial infarction, respiratory failure, or recent worsening congestive heart failure.
[October 12, 2007 - Drug Information Page - FDA]
[October 12, 2007 - Information for Healthcare Professionals - FDA]
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-
- Cochlear Implants
- Audience: ENT specialists, pediatricians, infectious disease specialists, other healthcare professionals, consumers
[Posted 10/10/2007] FDA informed healthcare professionals and consumers that the Cochlear Implant device used in profoundly deaf or severely hard-of hearing patients has been associated with some increased risk of bacterial meningitis caused by Streptococcus pneumoniae. Children implanted with Cochlear Implants with a positioner component are at a greater risk. There were two cases of deaths from meningitis within the past year in children, ages 9 and 11, implanted with cochlear implants with positioners. Neither child was fully vaccinated, and one died because of the lack of vaccination.
FDA reminds healthcare professionals and consumers that recipients of this device must be fully immunized according to the Center for Disease (CDC) vaccination recommendations. Because children with Cochlear Implants are at increased risk for pneumococcal meningitis, CDC recommends that they receive pneumococcal vaccination under the same schedules that apply to other individuals at high risk for invasive pneumococcal disease.
[October 10, 2007 - Public Health Notification - FDA]
[October 10, 2007 - Advice for Patients - FDA]
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- Bisphosphonates marketed as Alendronate
(Fosamax, Fosamax Plus D), Etidronate (Didronel), Ibandronate (Boniva), Pamidronate (Aredia), Risedronate (Actonel, Actonel W/Calcium), Tiludronate (Skelid), and Zoledronic acid (Reclast, Zometa)
- Audience: Geriatricians, gynecologists, orthopedic surgeons, other healthcare professionals, consumers
[Posted 10/01/2007] FDA issued an early communication about the ongoing review of new safety data regarding the association of atrial fibrillation with the use of bisphosphonates. Bisphosphonates are a class of drugs used primarily to increase bone mass and reduce the risk for fracture in patients with osteoporosis, slow bone turnover in patients with Paget’s disease of the bone, treat bone metastases, and lower elevated levels of blood calcium in patients with cancer.
FDA reviewed spontaneous postmarketing reports of atrial fibrillation reported in association with oral and intravenous bisphosphonates and did not identify a population of bisphosphonate users at increased risk of atrial fibrillation. In addition, as part of the data review for the recent approval of once-yearly Reclast for the treatment of postmenopausal osteoporosis, FDA evaluated the possible association between atrial fibrillation and the use of Reclast. Most cases of atrial fibrillation occurred more than a month after drug infusion. Also, in a subset of patients monitored by electrocardiogram up to the 11th day following infusion, there was no significant difference in the prevalence of atrial fibrillation between patients who received Reclast and patients who received placebo.
Upon initial review, it is unclear how these data on serious atrial fibrillation should be interpreted. Therefore, FDA does not believe that healthcare providers or patients should change either their prescribing practices or their use of bisphosphonates at this time.
[October 2007 - Early Communication - FDA]
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-
- Hydrocodone in Unapproved Prescription Products
- Audience: Healthcare professionals, pediatricians, consumers
[Posted 09/28/2007] FDA informed healthcare professionals and consumers of its intent to take action against companies that market unapproved prescription products containing hydrocodone, a narcotic widely used as a cough suppressant and to treat pain. The drug has also been an extremely popular drug of abuse and can lead to serious illness, injury, or death, if improperly used. Hydrocodone overdose can result in breathing problems or cardiac arrest, and its use may impair motor skills and judgment.
The FDA has received reports of medication errors associated with formulation changes in unapproved hydrocodone products and reports of confusion over the similarity of the names of unapproved products to approved drug products. Most of the hydrocodone formulations now marketed to suppress coughs have not been approved. The agency is particularly concerned about improper pediatric labeling of unapproved hydrocodone cough suppressants (also known as antitussives), and the risk of medication error involving the unapproved products. No hydrocodone cough suppressant has been established as safe and effective for children under 6 years of age and some of these unapproved products carry labels with dosing instructions for children as young as 2 years of age.
Anyone marketing unapproved hydrocodone products that are currently labeled for use in children younger than 6 years of age must end further manufacturing and distribution of the products on or before October 31, 2007. Those marketing any other unapproved hydrocodone drug products must stop manufacturing such products on or before December 31, 2007, and must cease further shipment in interstate commerce on or before March 31, 2008. Further legal action could be taken against those failing to meet these deadlines.
There are a number of alternatives for patients who might be using unapproved hydrocodone cough suppressants. Consumers should consult a healthcare professional for detailed guidance on treatment options.
[September 28, 2007 - News Release - FDA]
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-
- Baxa Corporation Exacta-Mix 2400 Operating Software Version 1.07 Pharmacy Compound System
- Audience: Compounding pharmacies, hospitals, other healthcare professionals
[Posted 09/27/2007] Baxa Corporation and FDA informed healthcare professionals of a class I recall of Exacta-Mix 2400 Operating Software Version 1.07, Model No. 8300-0073, Pharmacy Compound System. The device is a compounding system that can be used in pharmacies to add and mix various ingredients into one intravenous (IV) solution.
The device is being recalled because a software failure allowed up to 50mL extra volume of an ingredient to be added to the IV solution that can be life-threatening, particularly in newborns.
FDA advises healthcare professionals to stop using this product and contact the manufacturer for a replacement.
[September 27, 2007 - Recall Notice - FDA]
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-
- Axcil and Desirin (marketed as dietary supplements)
- Audience: Consumers, healthcare professionals
[Posted 09/21/2007] TWC Global LLC, Inc., issued a nationwide recall of Axcil and Desirin, both marketed as dietary supplements, because they contain potentially harmful, undeclared ingredients. FDA laboratory analysis of Axcil and Desirin found that the lot of 02B07 contained 3mg/g of sildenafil, the active ingredient of a FDA approved drug used for Erectile Dysfunction (ED). The products also contained sulfosildenafil and sulfohomosildenafil, which are analogs of sildenafil. All of these undeclared chemicals pose a threat to consumers because they may interact with nitrates found in some prescription drugs (such as nitroglycerin) and may lower blood pressure to dangerous levels.
Consumers with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates. Sexual dysfunction is a common problem in men and women with these conditions, and consumers may seek these types of products to enhance sexual performance. Consumers who have these products should stop using them immediately and consult their healthcare professional if they experience any problems that may be due to these products.
[September 20, 2007 - Recall Notice - FDA]
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-
- Baby's Bliss Gripe Water, Apple flavor
- Audience: Consumers, caregivers, pediatricians, other healthcare providers
[Posted 09/21/2007] MOM Enterprises Inc., and FDA informed consumers and healthcare providers that Baby's Bliss Gripe Water, apple flavor, with a code of 26952V and expiration date of October 2008 (10/08) is being recalled due to the presence of Cryptosporidium infection. The product is labeled Baby's Bliss. Pediatrician Recommended Gripe Water. Apple Flavor. An herbal supplement used to ease the gas and stomach discomfort often associated with colic, hiccups, and teething in infants and children.
FDA is investigating the illness of a 6-week old infant who consumed the product. The most common symptom of Cryptosporidium infection is watery diarrhea. Other symptoms include dehydration, weight loss, stomach cramps or pain, fever, nausea, and vomiting. Symptoms generally begin two to ten days after becoming infected with the parasite and generally last one to two weeks. The infection could be life-threatening for certain individuals, including infants, children, and individuals with weakened immune systems.
FDA advises parents/caregivers of children who have recently consumed Baby's Bliss Gripe Water, apple flavor, and have these symptoms to seek immediate medical attention. Parents and caregivers who have given this product to their infants and children should be alert for diarrhea and other signs of Cryptosporidium infection. FDA advises consumers to stop using this product and throw away bottles of the product immediately.
[September 20, 2007 - News Release - FDA]
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-
- MRL/Welch Allyn AED 20 Automatic External Defibrillators
- Audience: Emergency Services personnel and risk managers
[Posted 09/18/2007] FDA issued a Class I recall for MRL/Welch Allyn AED 20 Automatic External Defibrillators manufactured between October 2003 and January 2005, serial numbers 205787 through 207509. These devices are used by emergency or medical personnel to treat adult and pediatric patients in cardiopulmonary arrest (heart attack). The recalled devices may display a "Defib Comm" error message on the device display during use which may result in a terminal failure of the device to analyze the patient's ECG and deliver the appropriate therapy.
FDA advises healthcare professionals and patients to stop using the recalled product and contact the manufacturer for a replacement.
[September 18, 2007 - Recall Notice - FDA]
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-
- Haloperidol (marketed as Haldol, Haldol decanoate, and Haldol lactate)
- Audience: Neuropsychiatric and cardiovascular specialists, other healthcare professionals
[Posted 09/17/2007] Johnson and Johnson and FDA informed healthcare professionals that the WARNINGS section of the prescribing information for haloperidol has been revised to include a new Cardiovascular subsection regarding cases of sudden death, QT prolongation and Torsades de Pointes(TdP) in patients treated with haloperidol, especially when given intravenously, or at doses higher than recommended. Although injectable haloperidol is only approved by the FDA for intramuscular injection, there is considerable evidence that the intravenous administration of haloperidol is a relatively common off-label clinical practice. | |
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