Medical Product Safety Information

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Safety Alerts for Human Medical Products (Drugs, Biologics, Medical Devices, Special Nutritionals, and Cosmetics)

MedWatch alerts provide timely new safety information on human drugs, medical devices, vaccines and other biologics, dietary supplements, and cosmetics. The alerts contain actionable information that may impact both treatment and diagnostic choices for healthcare professional and patient.

2009 | 2008 | 2007 | 2006 | 2005 | 2004 | 2003 | 2002 | 2001 | 2000

 

Drug Safety Labeling Changes

Monthly summaries of drug products with safety labeling changes to the BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, or PATIENT PACKAGE INSERT/MEDICATION GUIDE sections.

2009: Jan|Feb|Mar|Apr|May|Jun|Jul

2008: Jan|Feb|Mar|Apr|May|Jun|Jul|Aug|Sep|Oct|Nov|Dec

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Other FDA Safety-Related Information

 

FDA Patient Safety News

• Video News Show for Health Professionals

DailyMed (FDA/National Library of Medicine) 

• Comprehensive, up-to-date, look-up and download resource of medication content and labeling as found in medication package inserts

Drug Products

• Index to Drug-Specific Information
• Medication Guides
  FDA-approved patient information for selected prescription drugs that pose a serious and significant public health concern
• Potential Signals of Serious Risks/New Safety Information Identified from the Adverse Event Reporting System (AERS)
  Drugs for which FDA has identified a potential safety issue, but not a causal relationship between the drug and the listed risk.
• Medication Errors
• Drug Shortages

Medical Devices 

• Device Public Health Notifications
• Medical Device Recalls page

Biological Products

• Safety Information
• Recalls and Withdrawals

Dietary Supplements

• Warnings and Safety Information

 

Inquiries About Specific Products

 

Product Type	E-mail Inquiries	Telephone Inquiries
Drugs	Drug Information Questions and Comments	Division of Drug Information, 301-827-4570
Special Nutritional Products (dietary supplements, infant formulas, and medical foods) and Cosmetics	Food, Nutrition, and Cosmetics Questions & Answers	888-723-3366
Medical Devices	Center for Devices and Radiological Health, Division of Small Manufacturers, International and Consumer Assistance	800-638-2041
Vaccines, blood products, other biologics	Center for Biologics Evaluation and Research Questions	800-835-4709

 

Access to FDA Safety Data

• Adverse Event Reporting System (AERS)
  AERS collects information about adverse events, medication errors and product problems that occur after the administration of approved drug and therapeutic biologic products. Quarterly (noncumulative) data files since January 2004 are available for downloading on the AERS website.
• Vaccine Adverse Event Reporting System (VAERS)
  VAERS is a cooperative program for vaccine safety of the Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA). VAERS collects information about adverse events that occur after the administration of U.S. licensed vaccines.
• Manufacturer and User Facility Device Experience Database (MAUDE)
  Search database information of all voluntary reports since June, 1993, user facility reports since 1991, distributor reports since 1993, and manufacturer reports since August, 1996. (MDR Data files, 1992-1996)