The FDA Safety Information and Adverse Event Reporting Program
"MedWatch, The FDA Safety Information and Adverse Event Reporting Program, serves both healthcare professionals and the medical product-using public. We provide important and timely clinical information about safety issues involving medical products, including prescription and over-the-counter drugs, biologics, medical and radiation-emitting devices, and special nutritional products (e.g., medical foods, dietary supplements and infant formulas). Medical product safety alerts, recalls, withdrawals, and important labeling changes that may affect the health of all Americans are quickly disseminated to the medical community and the general public via this web site and the MedWatch E-list. Select Safety Information to see reports, safety notifications, and labeling changes posted to the website since 1996. MedWatch allows healthcare professionals and consumers to report serious problems that they suspect are associated with the drugs and medical devices they prescribe, dispense, or use. Reporting can be done on line, by phone, or by submitting the MedWatch 3500 form by mail or fax. Select How to Report for more details."
Rockville, Md. : U.S. Food and Drug Administration