Safety
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Resources for You
Report a Serious Medical Product Problem Online Reporting Unlawful Sales of Medical Products on the Internet - Consumer-Friendly Reporting Form 3500B (PDF - 1.2MB)
Current Drug Shortages Index Identifying Recalled Products An FDA Guide to Drug Safety Terms Voluntary Adverse Event Reporting Contact Information MedWatch Partners
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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. |
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What's New
Zyprexa Relprevv (Olanzapine Pamoate): Drug Safety Communication - FDA Investigating Two Deaths Following Injection Two patients died 3-4 days after receiving an appropriate dose of the drug. Posted 06/18/2013 Endologix, Inc. AFX Introducer System: Class 1 Recall - Reports Of Dilator Breaking During Procedures Use of this recalled product may cause serious adverse health consequences, including death. Posted 06/18/2013 Cybersecurity for Medical Devices and Hospital Networks: FDA Safety Communication Many medical devices contain configurable embedded computer systems that can be vulnerable to cybersecurity breaches. Posted 06/17/2013 Main Street Family Pharmacy in Tennessee: FDA Alerts Health Care Providers of Adverse Reactions Associated with Steroid Injections UPDATED 06/13/2013. FDA identified the specific bacterial and fungal growth in two MPA lots. Originally posted 05/24/2013. May 2013 Safety Labeling Changes includes 40 products with revisions to Prescribing Information. Posted 06/13/2013 Vecuronium Bromide For Injection by Sagent Pharmaceuticals, Inc.: Recall - Elevated Impurity Result Detected UPDATED 06/13/2013. Recall expanded to all lots. The elevated impurity result has the potential to result in prolonged neuromuscular blockade for critically ill patients with renal failure. Originally posted 06/10/2013
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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) (formerly AERS) Postmarket Drug and Biologic Safety Evaluations
Evaluations performed 18 months after drug approval, or after its use by 10,000 individuals.
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