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.
Mammograms at Coastal Diagnostic Center in Pismo Beach, California: FDA Safety Communication - Quality Problems Patients may need a repeat mammogram or additional medical follow-up. Posted 04/30/2015 Injectable Products by Mylan: Recall - Presence of Particulate Matter Administration of a sterile injectable that has foreign particulates has the potential of severe health consequences. Posted 04/24/2015 Bupivacaine HCl Injection by Hospira: Recall - Iron Oxide Particulate In Glass Vials Injected particulate may result in local inflammation, low-level allergic or immune responses, granuloma formation or mechanical irritation of tissue. Posted 04/24/2015
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.