Drugs.com - FDA MedWatch Alerts

Vicks Sinex Nasal Spray - Recall

Thu, 19 Nov 2009 05:00:00 GMT

Audience: Consumers Procter & Gamble and FDA notified consumers of a voluntary recall of three lots of Vicks Sinex Nasal Spray in the United States, Germany and the United Kingdom. The bacteria B. cepacia was found in a small amount of...

RockHard Weekend - product contains undeclared drug ingredient

Wed, 18 Nov 2009 05:00:00 GMT

Audience: Consumers, pharmacists RockHard Laboratories and FDA notified consumers that RockHard Weekend, a product sold as a dietary supplement, contains sulfoaildenafil, an analogue of sildenafil, an FDA-approved drug used as...

Clopidogrel (marketed as Plavix) and Omeprazole (marketed as Prilosec) - Drug Interaction

Tue, 17 Nov 2009 05:00:00 GMT

Audience: Cardiovascular healthcare professionals, pharmacists FDA notified healthcare professionals of new safety information concerning an interaction between clopidogrel (Plavix), an anti-clotting medication, and omeprazole (Prilosec/Prilosec...

IDS Sports Dietary Supplements - Recall

Tue, 17 Nov 2009 05:00:00 GMT

Audience: Consumers IDS Sports and FDA notified consumers that five of the IDS's dietary supplement products (Bromodrol, Dual Action Grow Tabs, Grow Tabs, Mass Tabs, and Ripped Tabs TR) contain the following undeclared substances, which FDA...

Local Anesthetics, Continuously Infused (marketed as bupivacaine, chlorprocaine, lidocaine, mepivacaine, procaine, ropivacaine) - Chondrolysis

Fri, 13 Nov 2009 05:00:00 GMT

Audience: Orthopedic and Anesthesia healthcare professionals, hospital risk managers [Posted 11/13/2009] FDA notified healthcare professionals of 35 reports of chondrolysis (necrosis and destruction of cartilage) in patients given continuous...

Genzyme Products, Marketed as Cerezyme, Fabrayzme, Myozyme, Aldurazyme, and Thyrogen

Fri, 13 Nov 2009 05:00:00 GMT

Audience: Endocrinological and Genetics Medicine healthcare professionals FDA and Genzyme notified healthcare professionals about the potential for foreign particle contamination of several products that are used to treat rare, serious, and...

Local Anesthetics, Continuously Infused (marketed as bupivacaine, chloroprocaine, lidocaine, mepivacaine, procaine, ropivacaine) - Chondrolysis

Fri, 13 Nov 2009 05:00:00 GMT

Audience: Orthopedic and Anesthesia healthcare professionals, hospital risk managers FDA notified healthcare professionals of 35 reports of chondrolysis (necrosis and destruction of cartilage) in patients given continuous intra-articular...

Pai You Guo, Marketed as Dietary Supplement - Recall

Fri, 13 Nov 2009 05:00:00 GMT

Audience: Consumers GMP Herbal Products and FDA notified consumers and healthcare professionals of a recall of Pai You Guo, a weight loss dietary supplement, due to the presence of undeclared drug ingredients. FDA lab analyses of dietary...

Hospira Brand Propofol and Liposyn Products - Recall

Mon, 09 Nov 2009 05:00:00 GMT

Audience: Anesthesiology and intensivist healthcare professionals, hospital risk managers Hospira, Inc.and FDA notified healthcare professionals of the recall of 85 lots of Liposyn II 10%, Liposyn II 20%, Liposyn III 10%, Liposyn III 20%, and...

Stiff Nights - product contains undeclared drug ingredient

Thu, 05 Nov 2009 05:00:00 GMT

Audience: Consumers, Pharmacists FDA notified consumers that Stiff Nights, a product sold as a dietary supplement, contains sulfoaildenafil, a chemical similar to sildenafil, the active ingredient in Viagra. Sulfoaildenafil may interact with...

Dietary Supplements Sold on Internet by Bodybuilding.com

Tue, 03 Nov 2009 05:00:00 GMT

Audience: Consumers [Posted 11/03/2009] Bodybuilding.com and FDA notified healthcare professionals and patients of a nationwide and international recall of all lots and expiration dates of 65 dietary supplement products that were sold through the...

Bodybuilding.com Brand Dietary Supplements - Sold on Internet

Tue, 03 Nov 2009 05:00:00 GMT

Audience: Consumers Bodybuilding.com and FDA notified healthcare professionals and patients of a nationwide and international recall of all lots and expiration dates of 65 dietary supplement products that were sold through the Company's website,...

Ketorolac Tromethamine Injection, USP 30 mg/mL; 1mL and 2mL Single Dose Vials -- Recall

Tue, 03 Nov 2009 05:00:00 GMT

Audience: Hospital risk managers, surgical center staff, pharmacists [UPDATED 11/03/2009] Recall expanded to include all lots of product. [Posted 10/21/2009] American Regent and FDA notified healthcare professionals of a voluntary recall of all...

Byetta (exenatide) - Renal Failure

Mon, 02 Nov 2009 05:00:00 GMT

Audience: Endocrine and nephrology healthcare professionals FDA notified healthcare professionals of revisions to the prescribing information for Byetta (exenatide) to include information on post-marketing reports of altered kidney function,...

Accusure Insulin Syringes (Qualitest Pharmaceuticals) - Recall

Tue, 27 Oct 2009 04:00:00 GMT

Audience: Diabetes healthcare professionals and patients Qualitest Pharmaceuticals and FDA notified healthcare professionals of a nationwide recall of Accusure Insulin Syringes. All syringes, regardless of lot number, are subject to this recall....

Peramivir IV

Sat, 24 Oct 2009 04:00:00 GMT

Audience: Infectious disease healthcare professionals, hospital risk managers FDA notified healthcare professionals that, in response to a request from the U.S. Centers for Disease Control and Prevention, it has issued an emergency use...

Rituxan (rituximab) - PML

Fri, 23 Oct 2009 04:00:00 GMT

Audience: Rheumatological healthcare professionals Genentech and FDA notified healthcare professionals about a third case of progressive multifocal leukoencephalopathy [PML], the first case of PML in a patient with rheumatoid arthritis [RA]...

Ketorolac Tromethamine Injection, USP 30 mg/mL; 1mL and 2mL Single Dose Vials -- Recall

Wed, 21 Oct 2009 04:00:00 GMT

Audience: Hospital risk managers, surgical center staff, pharmacists American Regent and FDA notified healthcare professionals of a voluntary recall of all lots of Ketorolac Tromethamine Injection, USP 30 mg/mL, including NDC#...

Dexferrum (iron dextran injection) - Labeling Change

Fri, 16 Oct 2009 04:00:00 GMT

Audience: Hematological healthcare professionals, hospital risk managers American Regent and FDA notified healthcare professionals that anaphylactic-type reactions, including fatalities, have followed the parenteral administration of iron...

Tamiflu (oseltamivir) for Oral Suspension

Fri, 16 Oct 2009 04:00:00 GMT

Audience: Pharmacists, pediatrics healthcare professionals [UPDATED 10/16/2009] FDA News Release: FDA Warns of Unapproved and Illegal H1N1 Drug Products Purchased Over the Internet. [UPDATED 10/05/2009] New information added to web...

Relenza (zanamivir) Inhalation Powder

Fri, 09 Oct 2009 04:00:00 GMT

Audience: Infectious disease healthcare professionals, hospital risk managers [Posted 10/09/2009] GlaxoSmithKline (GSK) and FDA notified healthcare professionals of a report of the death of a patient with influenza who received Relenza...

Heparin: Change in Reference Standard

Thu, 01 Oct 2009 04:00:00 GMT

Audience: Pharmacists, physicians, hospital risk managers and consumers FDA notified healthcare professionals and patients of a change to heparin, effective October 1, 2009, which will include a new reference standard and test method used to...

Neocate Infant Specialized Formula - Recall

Tue, 29 Sep 2009 04:00:00 GMT

Audience: Pediatric healthcare professionals, pharmacists, caregivers Nutricia and FDA notified healthcare professionals of the voluntary recall of one lot [# P91877] of the specialized infant formula product, Neocate, a hypoallergenic dry powder...

Children's and Infants' Tylenol Oral Suspension Products - Recall

Sat, 26 Sep 2009 04:00:00 GMT

Audience: Consumers and Healthcare professionals [Posted 09/25/2009] McNeil Consumer Healthcare and FDA notified consumers of a nationwide recall of certain Tylenol products as a precautionary measure because of potential manufacturing...

Medtronic Neuromodulation, INDURA 1P Intrathecal Catheter, Intrathecal Catheter, Sutureless Pump Connector Revision Kit, and Intrathecal Catheter Pump Segment Revision Kit

Fri, 25 Sep 2009 04:00:00 GMT

Audience: Physical medicine and rehabilitation specialists, anesthesia healthcare professionals, hospital surgical service managers [Posted 09/24/2009] FDA notified healthcare professionals of the Class 1 recall of Medtronic SC Catheters and...

Tamiflu (oseltamivir) for Oral Suspension: Potential Medication Errors

Fri, 25 Sep 2009 04:00:00 GMT

Audience: Pharmacists, pediatrics healthcare professionals [UPDATED 09/25/2009] New links added to provide information on emergency use in infants less than 1 year of age and directions to pharmacists on emergency compounding of oral suspension...

Children's and Infants' Tylenol Oral Suspension Products - Recall

Fri, 25 Sep 2009 04:00:00 GMT

Sitagliptin (marketed as Januvia and Janumet) - acute pancreatitis

Fri, 25 Sep 2009 04:00:00 GMT

Audience: Diabetes healthcare professionals, patients FDA notified healthcare professionals and patients of revisions to the prescribing information for Januvia (sitagliptin) and Janumet (sitagliptin/metformin) to include information on reported...

Exjade (deferasirox) - Early Communication

Fri, 25 Sep 2009 04:00:00 GMT

Audience: Hematology-Oncology healthcare professionals FDA notified healthcare professionals of an Early Communication regarding an ongoing review of safety issues with Exjade (deferasirox). New safety data suggests there may be a greater number...

Tamiflu for Oral Suspension: Potential Medication Errors

Thu, 24 Sep 2009 04:00:00 GMT

Audience: Pharmacists, pediatrics healthcare profesionals FDA issued a Public Health Alert to notify prescribers and pharmacists about potential dosing errors with Tamiflu (oseltamivir) for Oral Suspension. U.S. health care providers usually write...

Natalizumab (marketed as Tysabri)

Thu, 17 Sep 2009 04:00:00 GMT

Audience: Neurological healthcare professionals, patients FDA continues to receive reports of progressive multifocal leukoencephalopathy (PML) in patients receiving Tysabri. Tysabri was approved by the FDA for the treatment of relapsing forms of...

Promethazine Hydrochloride Injection

Wed, 16 Sep 2009 04:00:00 GMT

Audience: All healthcare professionals FDA notified healthcare professionals that a Boxed Warning is being added to the prescribing information for Promethazine Hydrochloride products, describing the risks of severe tissue injury, including...

Albuterol Sulfate Inhalation Solution unit-dose vials (Dey LP brand)

Thu, 10 Sep 2009 04:00:00 GMT

Audience: Pharmacists and pharmacy organizations [Posted 09/10/2009] FDA notified pharmacists that two complete Lots (9FE2 and 9G01) containing 35,760 cartons of Albuterol Sulfate Inhalation Solution, 0.083%, unit-dose vials was stolen in Texas...

Myfortic (mycophenolic acid)

Thu, 03 Sep 2009 04:00:00 GMT

Audience: Renal, cardiac, and hepatic transplantation healthcare professionals GlaxoSmithKline notified healthcare professionals that cases of Pure Red Cell Aplasia (PRCA) have been reported in patients treated with Myfortic. The WARNINGS and...

Tumor Necrosis Factor (TNF) Blockers (marketed as Remicade, Enbrel, Humira, Cimzia, and Simponi) August 2009

Mon, 31 Aug 2009 04:00:00 GMT

Audience: Rheumatologists, gastroenterologists, oncologists, dermatologists [UPDATED 08/31/2009] Supplemental Q&As added [Posted 08/04/2009] FDA notified healthcare professionals that it has completed its analysis of tumor necrosis factor (TNF)...

Leukotriene Inhibitors: Montelukast (marketed as Singulair), Zafirlukast (marketed as Accolate), and Zileuton (marketed as Zyflo and Zyflo CR)

Fri, 28 Aug 2009 04:00:00 GMT

Audience: Pulmonology healthcare professionals [UPDATED 08/28/2009] The June 12, 2009 Healthcare Professional Sheet has been updated. FDA provided healthcare professionals with updated information on the original March 2008 early communication and...

Intelence (etravirine)

Thu, 27 Aug 2009 04:00:00 GMT

Audience: Infectious disease healthcare professionals, patients Tibotec Therapeutics and FDA notified healthcare professionals of revisions to the WARNINGS AND PRECAUTIONS section of the prescribing information for Intelence (etravirine). There...

Levemir Insulin (Novo Nordisk)

Wed, 26 Aug 2009 04:00:00 GMT

Audience: Patients, pharmacists, diabetes healthcare professionals [UPDATED 08/26/2009] FDA is reminding the public that stolen vials of the long-acting insulin Levemir made by Novo Nordisk Inc. still may be on the market. Evidence gathered...

Accusure Insulin Syringes [31G, 1/2 cc and 1 cc]

Mon, 24 Aug 2009 04:00:00 GMT

Audience: Patients with diabetes mellitus, pharmacists and diabetes healthcare professionals Qualitest Pharmaceuticals and FDA notified patients and healthcare professionals of a voluntary nationwide recall of two lots of Accusure Insulin...

Orlistat (marketed as Alli and Xenical): Early Communication about an Ongoing Safety Review

Mon, 24 Aug 2009 04:00:00 GMT

Audience: Endocrinological healthcare professionals, patients FDA notified healthcare professionals and patients that it is reviewing new safety information regarding reports of liver-related adverse events in patients taking orlistat. Orlistat...