Resources for You
2014 Safety Alerts for Human Medical Products
- Contact Information For Voluntary Adverse Event Reporting
- MedWatchLearn - Teaching students, health professionals, and consumers how to report problems to FDA
Medical Product Safety Educational Resources
- Consumer-Friendly Reporting Form 3500B (PDF - 1.2MB)
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.
Bo Ying Compound by Eu Yan Sang (Hong Kong) Ltd: FDA/CDER Statement - Risk of Lead Poisoning Exposure to lead can cause serious damage to the central nervous system, the kidneys, and the immune system. Posted 09/26/2014 Xolair (omalizumab): Drug Safety Communication - Slightly Elevated Risk of Cardiovascular and Cerebrovascular Serious Adverse Events FDA approves label changes after review of a five year safety study. Posted 09/26/2014 Potassium Chloride Injection (Baxter): Recall - Shipping Carton Mislabeling Potential risk of medication error or delay in therapy for patients that require high concentration potassium chloride. Posted 09/17/2014
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.