MedWatch: Reporting on Adverse Events

Posted on April 29, 2008

FDA's Medwatch program allows health care professionals and consumers to report to the FDA serious problems with the medical products they prescribe, dispense, or use. These reports, along with follow-up investigations, can help to identify important safety concerns.

It is important to keep the MedWatch system working, and we can not do that without your help. Here are the kinds of reports we need from you:

• Report any serious adverse event that might be associated with a drug, biologic, medical device, or dietary supplement. By "serious" we mean fatalities, hospitalizations, and medically significant events. FDA is especially interested in serious adverse events that aren't listed in the product labeling.

• Report therapeutic failures - cases where the drug or device failed to work as it should (e.g., if a patient has to switch from one brand of a drug to another because the original one was ineffective).

• Report cases of use errors with medications or devices, including situations where the error may have been due to poor communication, or to ambiguities in product names, directions for use, or packaging.

• Report product quality issues, such as suspected counterfeit products, defective components, potential contamination, device malfunctions and poor packaging.

FDA encourages you to report these problems to MedWatch even if you are not sure that the product was the cause. It is easy to report by internet, phone, fax, or mail.

Additional Information:

MedWatch - The FDA Safety Information and Adverse Event Reporting System.
http://www.fda.gov/medwatch/