Reporting Adverse Events for Drugs, Devices, Biologics and Dietary Supplements

An important FDA program called "MedWatch" allows health care professionals and consumers to report serious problems that they suspect are associated with the medical products they prescribe, dispense, or use. These reports, along with follow-up investigations, can help to identify important safety concerns.

It's important to keep the MedWatch system working, and FDA needs your help. Here are the kinds of reports that should be submitted:

Report any serious adverse event that might be associated with a drug, biologic, medical device, or dietary supplement, particularly serious adverse events that are not listed in the product labeling. "Serious" means fatalities, hospitalizations, and medically significant events.

Report therapeutic failures - cases in which 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 reporting these problems to MedWatch even if you're not sure that the product was the cause. It's 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/

MedWatch: Managing Risks at the FDA. FDA Consumer Sept/Oct 2003
http://www.fda.gov/fdac/features/2003/503_risk.html

This information is summarized from the FDA website.  To learn more about the MedWatch program and to read this announcement in its entirety click here.