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.
Intravia Containers by Baxter: Recall - Particulate Matter Intravenous administration of a solution containing steril particulate matter may lead to adverse health consequences. Posted 10/25/2014 Lidocaine HCI Injection, USP 10 MG Per ML, 30 ML Single-Dose, Preservative-Free, by Hospira: Recall - Particulate Matter Injected particulate material may result in local inflammation, phlebitis, and/or low-level allergic response to the particulate or microembolic effects.Posted 10/17/2014 Assured Brand Naproxen Sodium Tablets by Contract Packaging Resources, Inc.: Recall - Packaging Mix-Up Risk of allergic reactions, from mild irritation or hives to serious reactions such as anaphylaxis that may be life-threatening. Posted 10/22/2014 Saba Shark Cartilage Complex, 60 Capsule Bottles: Recall - Possible Salmonella Contamination Salmonella can cause serious and sometimes fatal infections in young children frail or elderly people, and others with weakened immune systems. Posted 10/20/2014
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.