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.
What's New
November 2015 Drug Safety Labeling Changes includes 19 products with revisions to Prescribing Information. Posted 12/11/2015 Chariot Guiding Sheath by Boston Scientific: Recall - Risk of Shaft Separation Device failure could lead to embolism of device fragments, which could lead to obstruction of blood flow or additional intervention to remove a device fragment. Posted 12/11/2015 Baclofen Active Pharmaceutical Ingredient from Taizhou Xinyou Pharmaceutical and Chemical: FDA Statement - FDA Warns of Potential Contamination The affected lots may potentially pose serious safety risks for U.S. patients who use or receive injectable drug products compounded with the affected baclofen, especially when administered directly into the spinal column. Posted 12/09/2015 Pink Bikini Dietary Supplement by Lucy's Weight Loss System: Recall - Undeclared Drug Ingredient Use of product may increase the risk of fatal heart attack or stroke, especially if used long term or taken in high doses, or if there is a history of heart disease. Posted 12/09/2015
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.)Medication Guides
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.