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Drugs.com FDA MedWatch Alerts
Latest alerts to consumers and health care providers warning of recently identified adverse effects associated with currently available drugs and supplements.
Updated: 3 sec ago
Saphris (asenapine maleate): Drug Safety Communication: Serious Allergic Reactions
Wed, 2011-08-31 23:00
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...
Categories: Medical Feeds
Reclast (zoledronic acid): Drug Safety Communication - New Contraindication and Updated Warning on Kidney Impairment
Wed, 2011-08-31 23:00
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...
Categories: Medical Feeds
H & P Industries Povidone Iodine Swabsticks, Prep Solutions, Scrub Solutions, and Prep Gel: Recall - Inadequate Microbial Testing
Thu, 2011-08-25 23:00
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...
Categories: Medical Feeds
Celexa (citalopram hydrobromide): Drug Safety Communication - Abnormal Heart Rhythms Associated With High Doses
Tue, 2011-08-23 23:00
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...
Categories: Medical Feeds
Vasopressin Injection USP, Multiple Dose Vials: Recall - Sub-Potency
Wed, 2011-08-03 23:00
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...
Categories: Medical Feeds
Recombinant Human Growth Hormone (somatropin): Ongoing Safety Review - Possible Increased Risk of Death
Wed, 2011-08-03 23:00
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...
Categories: Medical Feeds
Diflucan (fluconazole): Drug Safety Communication - Long-term, High-dose Use During Pregnancy May Be Associated With Birth Defects
Tue, 2011-08-02 23:00
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...
Categories: Medical Feeds
Slim Forte Slimming Capsules, Slim Forte Slimming Coffee, and Botanical Slimming Soft Gel: Public Notification - Undeclared Drug Ingredient
Tue, 2011-07-26 23:00
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...
Categories: Medical Feeds
CardioGen-82 PET Scan: Drug Safety Communication - Increased Radiation Exposure
Mon, 2011-07-25 23:00
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...
Categories: Medical Feeds
Zyvox (linezolid): Drug Safety Communication - Serious CNS Reactions Possible When Given to Patients Taking Certain Psychiatric Medications
Mon, 2011-07-25 23:00
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...
Categories: Medical Feeds
Methylene Blue: Drug Safety Communication - Serious CNS Reactions Possible When Given to Patients Taking Certain Psychiatric Medications
Mon, 2011-07-25 23:00
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...
Categories: Medical Feeds
Chantix (varenicline): Label Change - Risk of Certain Cardiovascular Adverse Events
Thu, 2011-07-21 23:00
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...
Categories: Medical Feeds
Multaq (dronedarone): Drug Safety Communication - Increased Risk of Death or Serious Cardiovascular Events
Wed, 2011-07-20 23:00
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...
Categories: Medical Feeds
Oral Osteoporosis Drugs (bisphosphonates): Drug Safety Communication - Potential Increased Risk of Esophageal Cancer
Wed, 2011-07-20 23:00
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...
Categories: Medical Feeds
American Regent Injectable Products: Recall - Visible Particulates in Products
Tue, 2011-07-19 23:00
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...
Categories: Medical Feeds
CardioGen-82 PET Scan: Drug Safety Communication - Increased Radiation Exposure
Thu, 2011-07-14 23:00
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...
Categories: Medical Feeds
Tamiflu (oseltamivir phosphate) for Oral Suspension: Label Change-New Concentration (6 mg/mL)
Sun, 2011-07-10 23:00
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...
Categories: Medical Feeds
Slim Forte Slimming Capsule and Slim Forte Double Power Slimming Capsules: Public Notification - Undeclared Drug Ingredient
Thu, 2011-07-07 23:00
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...
Categories: Medical Feeds
Nulojix (belatacept): Risk Evaluation and Mitigation Strategy (REMS)
Wed, 2011-07-06 23:00
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...
Categories: Medical Feeds
Valproate Products: Drug Safety Communication - Risk of Impaired Cognitive Development in Children Exposed In Utero (During Pregnancy)
Wed, 2011-06-29 23:00
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...
Categories: Medical Feeds
