MedWatch Reports Sought

The FDA needs to know about adverse events and product problems with medications (drugs or biologics), medical devices (including in-vitro diagnostics), special nutritional products (dietary supplements, medical foods, infant formulas) and other products regulated by FDA.

Under FDA's voluntary reporting systems, health professionals are urged to report serious adverse events with these products even if they are not certain the product caused the event, or if they don't have all the details. An event is serious when the patient outcome is death, life-threatening (real risk of dying), disability (significant, persistent or permanent), congenital anomaly, or required intervention to prevent permanent impairment or damage. Detailed information on how to report is available on the user-friendly reporting form. It is available at the MedWatch site on the FDA homepage on the Internet (http://www.fda.gov/medwatch) or by telephone to (800) FDA-1088. Reports may be submitted by mail, fax, or via the Internet.

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