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.
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 September 2014 Safety Labeling Changes includes 55 products with revisions to Prescribing Information. Posted 10/16/2014 LifeCare Flexible Intravenous Solutions by Hospira, Inc.: Recall - Potential for Leakage A puncture in the primary container may be difficult to detect and lead to contamination, compromised sterility, and other adverse events. Posted 10/15/2014 Medi-Trace Cadence and Kendall Multi-function Defibrillation Electrodes by Covidien: Field Safety Alert - Electrodes Will Not Connect with Philips FR3 or FRx AED units The mismatch of these devices could contribute to a delay in resuscitation and may contribute to subsequent death. Posted 10/12/2014
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.