MedWatch

MedWatch is the United States Food and Drug Administration's (FDA) program for reporting serious reactions, product quality problems, therapeutic inequivalence, and product use errors with human medical products, including drugs, biologics, medical and radiation-emitting devices, and special nutritional products (e.g., medical foods, dietary supplements and infant formulas).

History

The MedWatch system was established in 1993 by the FDA under the direction of then Commissioner David A. Kessler. The program's purpose is to educate health care professionals and the public about the importance of reporting serious problems to FDA, and to make doing so as easy and convenient as possible.

Reporting

Health professionals are strongly encouraged to report adverse events via MedWatch. Patients can also report adverse events directly, either online, by mail, or by fax.

Impact

MedWatch reports have led to changes in product labeling, product recalls, and other FDA safety alerts. The program has been credited with identifying significant public health issues related to medical products.

See also

• Pharmacovigilance
• Adverse event
• Food and Drug Administration

External links

• Official MedWatch website

MedWatch Resources
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