MedWatch Program

The MedWatch program is the division of the Food and Drug Administration that is responsible for safety information and adverse event reporting. Products covered under MedWatch include prescription and over-the-counter medications, medical foods, infant formulas, dietary supplements, medical devices, and radiation-emitting devices (medical equipment, cell phones, and so forth). Products not covered by MedWatch include vaccines, cosmetics, blood products, and veterinary products. Serious adverse events that would be reportable to Medwatch could have patient outcomes of hospitalization, permanent disability, congenital anomaly, death, or event requiring intervention to prevent permanent injury or death. Consumer and independent health care provider reporting to this organization is entirely voluntary. Medwatch receives approximately 5000 voluntary reports per year. For these reports, the health care provider is not required to prove causality between event and product, a suspicion of association is sufficient. The FDA is also interested in problems with product contamination, therapeutic failures, or confusing or unclear labeling. In addition to MedWatch, the FDA has the Medical Device Reporting (MDR) Program, which receives approximately 100,000 reports per year. User facilities such as hospitals and nursing homes are required to report deaths suspected of being related to medical devices, to both the manufacturer and the FDA via the Medwatch 3500A reporting form. The determination of causality is made by personnel observing the event.

In 2001, 41% of MedWatch claims were filed by pharmaceutical companies, 11% by physicians, and the remainder by consumers. The apparent underuse of MedWatch by physicians is based primarily on lack of knowledge of its existence; it is estimated that 1% to 10% of severe adverse events are actually reported to MedWatch.