Drugs.com - FDA MedWatch Alerts

Enbrel (etanercept)

Thu, 01 May 2008 04:00:00 GMT

Audience: Rheumatologists, dermatologists, other healthcare professionals, patients [Posted 05/01/2008] Amgen and Wyeth Pharmaceuticals informed healthcare professionals of revisions to prescribing information for Enbrel. The revisions include a...

Total Body Formula, Total Body Mega Formula

Thu, 01 May 2008 04:00:00 GMT

Audience: Consumers, healthcare professionals [UPDATE 05/01/2008] FDA notified healthcare professionals and consumers that the Agency's final analysis of certain flavors of "Total Body Formula" and "Total Body Mega Formula" detected hazardous...

Heparin Sodium Injection

Tue, 29 Apr 2008 04:00:00 GMT

Audience: Surgeons, dialysis center staff, hospital risk managers, and other healthcare professionals [UPDATE 04/29/2008] Update to healthcare facilities and healthcare professionals about Heparin and Heparin-containing medical products. [UPDATE...

Digitek (digoxin tablets, USP)

Mon, 28 Apr 2008 04:00:00 GMT

Audience: Cardiologists, family physicians, pharmacists, other healthcare professionals, patients [Posted 04/28/2008] Actavis Totowa LLC notified healthcare professionals of a Class I nationwide recall of all strengths of Digitek, a drug used to...

Herbal Science International, Inc. Dietary Herbal Supplements

Mon, 14 Apr 2008 04:00:00 GMT

Audience: Consumers, healthcare professionals [Posted 04/14/2008] Herbal Science International, Inc. and FDA informed consumers and healthcare professionals of a nationwide recall of twelve dietary supplements that contain ephedra, aristolochic acid...

CellCept (mycophenolate mofetil), Myfortic (mycophenolate acid)

Thu, 10 Apr 2008 04:00:00 GMT

Audience: Transplantation specialists, infectious disease specialists, other healthcare professionals [Posted 04/10/2008] FDA informed healthcare professionals that the Agency is investigating a potential association between the use of CellCept and...

Total Body Formula, Total Body Mega Formula

Thu, 10 Apr 2008 04:00:00 GMT

Audience: Consumers [UPDATE 04/10/2008] The FDA notified healthcare professionals and patients that it has found hazardous levels of selenium in samples of certain flavors of the dietary supplement products "Total Body Formula" and "Total Body Mega...

Exubera (insulin human rDNA origin) Inhalation Powder

Wed, 09 Apr 2008 04:00:00 GMT

Audience: Endocrinologists, pulmonologists, pharmacists, patients [Posted 04/09/2008] Pfizer informed healthcare professionals and patients of updated safety information in the WARNINGS section of prescribing information for Exubera, a short-acting...

Cubicin (daptomycin for injection)

Wed, 09 Apr 2008 04:00:00 GMT

Audience: Infectious disease healthcare professionals, hospital risk managers, and nursing service managers [Posted 04/09/2008] Cubist Pharmaceuticals, Inc. informed healthcare professionals that a potentially significant impurity,...

Neupro (rotigotine transdermal system)

Wed, 09 Apr 2008 04:00:00 GMT

Audience: Neurologists, other healthcare professionals, patients [Posted 04/09/2008] Schwarz Pharma informed healthcare professionals and patients of the recall of Neupro, a transdermal delivery system worn on the skin and used to treat early stage...

Heparin Sodium USP Pre-Filled Syringes

Wed, 02 Apr 2008 04:00:00 GMT

Audience: Surgeons, hospital risk managers, pharmacists, other healthcare professionals [Posted 04/02/2008] Covidien notified healthcare professionals of a voluntary recall of certain lots of Heparin Sodium USP because two lots of the product...

Relenza (zanamivir)

Wed, 02 Apr 2008 04:00:00 GMT

Audience: Pediatric and infectious disease healthcare professionals [Posted 04/01/2008] GlaxoSmithKline informed healthcare professionals of changes to the WARNINGS AND PRECAUTIONS sections of prescribing information for Relenza regarding...

Total Body Formula, Total Body Mega Formula

Fri, 28 Mar 2008 04:00:00 GMT

Audience: Consumers [Posted 03/28/2008] The FDA notified consumers of a recall of, and advised them not to purchase or consume, the liquid dietary supplement products Total Body Formula in the flavors of Tropical Orange and Peach Nectar, or Total...

Ziagen (abacavir) and Videx (didanosine)

Thu, 27 Mar 2008 04:00:00 GMT

Audience: Infectious disease specialists, other healthcare professionals, patients [Posted 03/27/2008] The FDA issued an Early Communication about recent findings of The Data Collection on Adverse Events of Anti-HIV Drugs Study. Data analyses from...

Regranex (becaplermin) Gel

Thu, 27 Mar 2008 04:00:00 GMT

Audience: Endocrinologists, other healthcare professionals, patients [Posted 03/27/2008] The FDA is conducting a safety review based on study data suggesting there may be an increased risk of death from cancer in diabetic patients using Regranex...

Singulair (montelukast)

Thu, 27 Mar 2008 04:00:00 GMT

Audience: Pulmonologists, respiratory therapists, other healthcare professionals, patients[Posted 03/27/2008] FDA informed healthcare professionals and patients of the Agency's investigation of the possible association between the use of Singulair...

"Blue Steel" and "Hero" Dietary Supplement Products

Tue, 25 Mar 2008 04:00:00 GMT

Audience: Consumers [Posted 03/25/2008] The U.S. Food and Drug Administration is advising consumers not to purchase or use "Blue Steel" or "Hero" products, marketed nationally as dietary supplements, because these products contain undeclared...

B. Braun Heparin Sodium in 5% Dextrose and 0.9% Sodium Chloride Injection Solution

Fri, 21 Mar 2008 04:00:00 GMT

Audience: Surgeons, dialysis center staff, hospital risk managers, other healthcare professionals [Posted 03/21/2008] B. Braun Medical Inc. was notified by its supplier, Scientific Protein Laboratories LLC (SPL) of a nationwide recall of Heparin...

Medtronic Neuromodulation SynchroMed EL, SynchroMed II and IsoMed Implantable Infusion Pumps

Fri, 21 Mar 2008 04:00:00 GMT

Audience: Physiatry and Pain management healthcare professionals [Posted 03/21/2008] FDA and Medtronic notified healthcare professionals of the Class 1 recall of Medtronic Neuromodulation Implantable Infusion Pumps, implantable devices for...

Prezista (darunavir)

Fri, 21 Mar 2008 04:00:00 GMT

Audience: Infectious disease healthcare professionals [UPDATE 3/21/2008] FDA issued a new "Information for Healthcare Professionals" sheet highlighting the addition of hepatotoxicity information to the WARNINGS section of prescribing...

Tiotropium (marketed as Spiriva HandiHaler)

Tue, 18 Mar 2008 04:00:00 GMT

Audience: Pulmonary care health professionals and patients [Posted 03/18/2008] Boehringer Ingelheim and FDA notified healthcare professionals that ongoing safety monitoring has identified a possible increased risk of stroke in patients who take...

Medtronic AneuRx Stent Graft System

Tue, 18 Mar 2008 04:00:00 GMT

Audience: Vascular surgery healthcare professionals, hospital surgical service managers [Posted 03/18/2008] FDA issued a Public Health Notification to inform healthcare professionals of an update to earlier FDA safety information on this product....

Erythropoiesis Stimulating Agents: Aranesp (darbepoetin alfa), Epogen (epoetin alfa), and Procrit (epoetin alfa)

Wed, 12 Mar 2008 04:00:00 GMT

Audience: Oncological healthcare professionals [Posted 03/12/2008] Amgen and FDA notified healthcare professionals of changes to the Boxed Warnings/WARNINGS: Increased Mortality and/or Tumor Progression section of the Aranesp and EPOGEN/PROCRIT...

Prezista (darunavir)

Wed, 12 Mar 2008 04:00:00 GMT

Audience: Infectious disease healthcare professionals [Posted 03/12/2008] FDA and Tibotec Therapeutics notified healthcare professionals of changes to the WARNINGS section of the prescribing information for Prezista (darunavir) tablets regarding the...

Long-Acting Hydrocodone-Containing Cough Product (marketed as Tussionex Pennkinetic Extended-Release Suspension)

Tue, 11 Mar 2008 04:00:00 GMT

Audience: Healthcare professionals, pharmacists, patients [Posted 03/11/2008] FDA informed healthcare professionals of life-threatening adverse events and death in patients, including children, who have received Tussionex Pennkinetic...

Chattem Icy Hot Heat Therapy Products

Tue, 11 Mar 2008 04:00:00 GMT

Audience: Consumers, healthcare professionals [UPDATED 03/11/2008] FDA issued a Class II Recall of all Icy Hot Heat Therapy products. [Posted 02/11/2008] Chattem, Inc. and FDA informed consumers and healthcare professionals of a voluntary...

Blood Glucose Meters and Test Strips

Tue, 11 Mar 2008 04:00:00 GMT

Audience: Diabetes healthcare professionals, pharmacists and patients [Posted 03/11/2008] FDA reminded glucose meter users to only use strips recommended for their specific brand of meter and to read the instructions for use carefully. It is...

Unapproved Over The Counter Drugs Marketed for Prevention and Treatment of STDs

Thu, 06 Mar 2008 05:00:00 GMT

Audience: Healthcare professionals, consumers [Posted 03/06/2008] FDA advised healthcare professionals and consumers that the Agency issued Warning Letters to six U.S. companies and one foreign individual for marketing unapproved and misbranded...

Aspire36, Aspire Lite Dietary Supplements

Tue, 04 Mar 2008 05:00:00 GMT

Audience: Consumers, healthcare professionals [Posted 03/04/2008] Palo Alto Labs and FDA notified consumers and healthcare professionals of a voluntary nationwide recall of two dietary supplements, Aspire36 and Aspire Lite. The products were...

Tamiflu (oseltamivir phosphate)

Tue, 04 Mar 2008 05:00:00 GMT

Audience: Pediatric and infectious disease healthcare professionals [Posted 03/04/2008] Roche and FDA informed healthcare professionals of neuropsychiatric events associated with the use of Tamiflu, in patients with influenza. These symptoms, as...

Fentanyl Transdermal System CII Patches

Mon, 03 Mar 2008 05:00:00 GMT

Audience: Pain management specialists, risk managers, other healthcare professionals, patients [UPDATED 03/03/2008] Actavis Inc. has voluntarily recalled of all lots of Fentanyl Transdermal System CII patches sold in the United States. [Posted...

Spiriva (tiotropium bromide inhalation powder) and Foradil (formoterol fumarate inhalation powder) Capsules

Fri, 29 Feb 2008 05:00:00 GMT

Audience: Pulmonologists, respiratory therapists, pharmacists, other healthcare professionals, patients [Posted 02/29/2008] FDA informed healthcare professionals and consumers of the correct way to use Spiriva and Foradil inhalation powder capsules....

Heparin Sodium Injection (Baxter)

Thu, 28 Feb 2008 05:00:00 GMT

Audience: Surgeons, dialysis center staff, hospital risk managers, and other healthcare professionals [UPDATE 02/28/2008] Baxter Healthcare Corporation has voluntarily recalled all of their multi-dose and single-use vials of heparin sodium for...

Tysabri (natalizumab)

Wed, 27 Feb 2008 05:00:00 GMT

Audience: Neurologists, other healthcare professionals, patients [Posted 02/27/2008] Biogen Idec, Elan and FDA notified healthcare professionals of reports of clinically significant liver injury, including markedly elevated serum hepatic enzymes and...

Denture Cleanser Allergic Reactions and Misuse

Tue, 26 Feb 2008 05:00:00 GMT

Audience: Dental healthcare professionals, patients [Posted 02/26/2008] FDA notified dental healthcare professionals and patients of the risk of serious allergic reactions in users of denture cleansers. These adverse events, including abdominal...

Avandia (rosiglitazone maleate)

Tue, 26 Feb 2008 05:00:00 GMT

Audience: Endocrinologists, pharmacists, patients [Posted 02/26/2008] FDA and GlaxoSmithKline notified pharmacists and physicians of a new Medication Guide for Avandia (rosiglitazone maleate). The FDA regulation 21CFR 208 requires a Medication Guide...

Fentanyl transdermal system CII Patches

Tue, 19 Feb 2008 05:00:00 GMT

Audience: Pain management specialists, risk managers, other healthcare professionals, patients [Posted 02/19/2008] Actavis Inc. announced a nationwide recall of certain lots of Fentanyl transdermal system CII Patches sold in the United States and...

Duragesic 25 mcg/hr (fentanyl transdermal system) CII Pain Patches

Fri, 15 Feb 2008 05:00:00 GMT

Audience: Pain management specialists, other healthcare professionals, patients [Posted 02/15/2008] PriCara and Sandoz Inc. announced a nationwide recall of all lots of 25 mcg/hr Duragesic Patches sold in the United States. The product is being...

Heparin Sodium Injection (Baxter)

Mon, 11 Feb 2008 05:00:00 GMT

Audience: Surgeons, dialysis center staff, hospital risk managers, and other healthcare professionals [Posted 02/11/2008] FDA informed healthcare professionals of important warnings and instructions for Heparin Sodium Injection use. There have been...

Chattem Icy Hot Heat Therapy Products

Mon, 11 Feb 2008 05:00:00 GMT

Audience: Consumers, healthcare professionals [Posted 02/11/2008] Chattem, Inc. and FDA informed consumers and healthcare professionals of a voluntary nationwide recall of its Icy Hot Heat Therapy products, including consumer "samples" that were...