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U.S. Department of Health and Human Services


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MedWatch Turns 20 and Looks Ahead

 MedWatch 20th Anniversary - Promoting Medical Product Safety and Public Health  
FDA comemorates the 20th anniversary of its MedWatch program by issuing a new reporting form designed specifically for consumers and issuing a new learning tool.  


 FDA is celebrating the 20th anniversary of its MedWatch program, which provides important safety information associated with FDA-regulated products, with a new form that will encourage more consumer participation. Under MedWatch, health care professionals and consumers submit reports to FDA when they find a problem with a drug, medical device, biologic, or other FDA-regulated products. Reporting to FDA such "adverse events" as unexpected, serious side effects, accidental exposure, and product quality issues can prompt the agency to act—and it can also bring new safety information forward and help the FDA take appropriate actions, including:


  • Making necessary changes on the label for a medication to better describe how the product should be used;
  • Influencing how a patient receiving the product should be monitored; and,
  • Issuing product recalls, warnings, corrections, or safety messages which FDA issues through MedWatch.


Over the years, most of the voluntary MedWatch forms have been submitted by health care professionals but recently consumers have been increasingly interested in participating in the program. The new, consumer-friendly MedWatch reporting form launched this week responded to consumer concerns that the form is too technical. FDA worked with groups such as AARP, Consumers Union, and the National Women's Health Network to develop a new Consumer Form.

Also being introduced is a new web-based learning tool, called MedWatchLearn. This tool is designed to educate students, health care professionals and consumers on how to properly complete a report. MedWatchLearn also provides examples of a quality report that includes critical information to help FDA evaluate the event or product quality complaint.


Learn more about reporting adverse events using FDA MedWatch by watching the following video:


Users can receive important alerts about drugs, medical products, and devices, by subscribing to MedWatch Safety Alerts email list-serv, following MedWatch on Twitter and subscribing to MedWatch Safety Alerts via RSS Feed.