Safety
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.
2011 | 2010 | 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.
2012: Jan|Feb|Mar|Apr|May|Jun|Jul|Aug|Sep
2011: Jan|Feb|Mar|Apr|May|Jun|Jul|Aug|Sep|Oct|Nov|Dec
2010: Jan|Feb|Mar|Apr|May|Jun|Jul|Aug|Sep|Oct|Nov|Dec
2009: Jan|Feb|Mar|Apr|May|Jun|Jul|Aug|Sep|Oct|Nov|Dec
2008: Jan|Feb|Mar|Apr|May|Jun|Jul|Aug|Sep|Oct|Nov|Dec
Archival MedWatch Information
- MedWatch Archive 1996 - 2007
This zip file is an html archive of MedWatch safety alerts from 1996 - 1999 and drug safety labeling change information from 1996 - 2007. Please keep in mind this is an archive of older MedWatch web pages. Certain hyperlinks, such as links to drug labels, no longer work. Please refer to Drugs@FDA for historical drug labeling.
Download the file to your computer, and extract (or unzip) the archive using the "Use folder names" option. This will create a folder on your computer named "MW-archive_1996-2007". Open that folder and launch the file called "safety_archive.htm" to browse the archive.
- MedWatch "What's New" Archive, May 29 - Dec 31, 2009
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
- Unapproved Drugs: Enforcement Actions
Enforcement efforts on classes of unapproved drugs or firms marketing unapproved drugs. - FDA Drug Info Rounds
Training videos for practicing clinical and community pharmacists.
Medical Devices
- Medical Device Safety page
- List of Tips and Articles on Medical Device Safety
Safety Tips for Laboratorians
Biological Products
Dietary Supplements
Inquiries About Specific Products
| Product Type | E-mail Inquiries | Telephone Inquiries |
| Drugs | Drug Information Questions and Comments
| Division of Drug Information 888-463-6332 (888-INFO-FDA) |
| 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)
