MedWatch: The FDA Safety Information and Adverse Event Reporting Program
Your FDA gateway for clinically important safety information and reporting serious problems with human medical products.
Duodenoscope Model TJF-Q180V by Olympus: FDA Safety Communication - New Reprocessing Instructions Validated If not properly reprocessed patients may be exposed to serious infections. Posted 03/26/2015 Mammograms at Richard D. Adelman M.D. in Raleigh, North Carolina: FDA Safety Communication - Quality Problems The facility may not perform mammography due to the revocation of its accreditation. Posted 03/24/2015 Hepatitis C Treatments Containing Sofosbuvir in Combination With Another Direct Acting Antiviral Drug: Drug Safety Communication - Serious Slowing of Heart Rate When Used With Antiarrhythmic Drug Amiodarone Postmarketing cases of serious and life-threatening symptomatic bradycardia, as well as one fatal cardiac arrest and cases requiring pacemaker insertion, have been reported. Posted 03/24/2015 Zyprexa Relprevv (olanzapine pamoate): Drug Safety Communication - FDA Review of Study Sheds Light on Two Deaths Associated with the Injectable Schizophrenia Drug FDA is unable to exclude the possibility that the deaths were caused by rapid, but delayed, entry of the drug into the bloodstream following intramuscular injection. Posted 03/23/2015 Over-the-Counter Asthma Products Labeled as Homeopathic: FDA Statement - Consumer Warning About Potential Health Risks If asthma is not appropriately treated and managed, patients may be at risk for life-threatening asthma attacks. Posted 03/19/2015 Lactated Ringer's Irrigation, 3000mL by Hospira: Recall - Mold Contamination Contaminated solution used on a patient may result in bacteremia, sepsis, septic shock and endocarditis, and death may result. Posted 03/12/2015 February 2015 Safety Labeling Changes includes 45 products with revisions to Prescribing Information. Posted 03/11/2015 Treanda (bendamustine hydrochloride) Solution by Teva: FDA Statement - Not Compatible with Closed System Transfer Devices, Adapters, and Syringes Containing Polycarbonate or Acrylonitrile-Butadiene-Styrene Can lead to device failure, possible product contamination, and potential serious adverse health consequences. Posted 03/10/2015 Chantix (varenicline): Drug Safety Communication - FDA Updates Label to Include Potential Alcohol Interaction Rare risk of seizures, and studies of side effects on mood, behavior, or thinking. Posted 03/09/2015
FDA Approved Safety Information
DailyMed (National Library of Medicine)
Current Drug Prescribing Information. (NOTE: Drugs marked "unapproved" on this site have not been reviewed by FDA for safety and efficacy, and their labeling has not been approved.)
Paper handouts that come with many prescription medicines. Medication Guides address issues specific to particular drugs and drug classes. They contain FDA-approved information that can help patients avoid serious adverse events.
Potential Signals of Serious Risks/New Safety Information Identified from the FDA Adverse Event Reporting System (FAERS) Postmarket Drug and Biologic Safety Evaluations
Evaluations performed 18 months after drug approval, or after its use by 10,000 individuals.