Drugs.com FDA MedWatch Alerts

Audience: Psychiatry, Patients [Posted 09/01/2011] ISSUE: FDA notified healthcare professionals and patients that serious allergic reactions have been reported with the use of Saphris (asenapine maleate). The Contraindications, Warnings and...

Audience: Endocrinology, Pharmacy, Patient ISSUE: FDA notified healthcare professionals and patients of an update to the drug label for Reclast (zoledronic acid) regarding the risk of kidney failure. Cases of acute renal failure requiring dialysis...

Audience: Pharmacy, Consumer, Risk Manager ISSUE: H & P Industries and FDA notified health professionals and the public of a recall of all lots (lots beginning with 8J-8M, 9A-9M, 0A-0M, 1A-1C) of Povidone Iodine Swabsticks, Prep Solutions, Scrub...

Audience: Psychiatry, Cardiology ISSUE: FDA notified healthcare professionals and patients that the antidepressant Celexa (citalopram hydrobromide) should no longer be used at doses greater than 40 mg per day because it can cause abnormal changes in...

Audience: Risk Manager, Pharmacy ISSUE: American Regent, Inc. is conducting a nationwide voluntary recall of multiple lots of Vasopressin Injection, USP to the Retail/Hospital level. This product recall was initiated by American Regent, Inc. because...

Audience: Pediatrics, Endocrinology [UPDATED 08/04/2011] FDA has determined that, at this time, the evidence regarding recombinant human growth hormone and increased risk of death is inconclusive. In its analysis of the SAGhE study, FDA identified...

Audience: OBGYN, Pharmacy, Infectious Disease ISSUE: FDA is informing the public that treatment with chronic, high doses (400-800mg/day) of Diflucan (fluconazole) during the first trimester of pregnancy may be associated with a rare and distinct set...

Audience: Consumer [Update 07/27/2011] - Intercharm Inc., is recalling Slimforte Slimming Capsules, Slimforte Slimming Coffee, and Botanical Slimming Soft Gel to the consumer/user level. These products are sold as dietary supplements and marketed...

Audience: Nuclear Medicine, Radiology, Patients [UPDATED 07/26/2011] FDA notified healthcare professionals to stop using CardioGen-82 for cardiac positron emission tomography (PET) scans. The manufacturer, Bracco Diagnostics, Inc. has decided to...

Audience: Infectious Disease, Psychiatry, Family Practice ISSUE: FDA has received reports of serious central nervous system (CNS) reactions when the antibacterial drug linezolid (Zyvox) is given to patients taking psychiatric medications that work...

Audience: Emergency Medicine, Critical Care Medicine, Psychiatry ISSUE: FDA has received reports of serious central nervous system (CNS) reactions when the drug methylene blue is given to patients taking psychiatric medications that work through the...

Audience: Family Medicine, Cardiology [UPDATED 07/22/2011] FDA has approved an updated drug label for Chantix (varenicline) to include information about the efficacy and safety of the drug in two patient populations who may benefit greatly from...

Audience: Healthcare Professionals ISSUE: FDA notified healthcare professionals that it is reviewing data from a clinical trial that evaluated the effects of the antiarrhythmic drug Multaq (dronedarone) in patients with permanent atrial...

Audience: Geriatrics, Family Practice, Internal Medicine Includes: Fosamax (alendronate), Actonel (risedronate), Boniva (ibandronate), Atelvia (risedronate delayed release), Didronel (etidronate), and Skelid (tiludronate) ISSUE: FDA notified...

Audience: Pharmacy Calcium Gluconate Injection, USP, 10%, 100 mL Pharmacy Bulk Package (Lot #1006) Concentrated Sodium Chloride Injection, USP 23.4%, 30 mL Single Dose Vials (Lot #0362) Methyldopate HCL Injection, USP 5ml Single Dose...

Audience: Nuclear Medicine, Radiology, Patients ISSUE: FDA notified the public and the medical imaging community about the potential for inadvertent, increased radiation exposure in patients who underwent or will be undergoing cardiac positron...

Audience: Pediatrics, Pharmacy Patients may potentially receive either concentration (6 mg/mL or 12 mg/mL) from their pharmacy during the next influenza season (2011-2012). ISSUE: Labeling changes are being made to Tamiflu oral suspension to reduce...

Audience: Consumer ISSUE: FDA is advising consumers not to purchase or use Slim Forte Slimming Capsule and Slim Forte Double Power Slimming Capsules. FDA laboratory analysis confirmed that these products contain sibutramine. Sibutramine is a...

Audience: Transplantation, Nephrology Increased Risk of Post-transplant Lymphoproliferative Disorder (PTLD), predominantly involving the Central Nervous System (CNS), and Progressive Multifocal Leukoencephalopathy (PML) ISSUE: Bristol-Myers Squibb...

Audience: OBGYN, Neurology, Psychiatry Including valproate sodium (Depacon), divalproex sodium (Depakote, Depakote CP, and Depakote ER), valproic acid (Depakene and Stavzor), and their generics ISSUE: FDA notified healthcare professionals that...