Harvard Heart Letter

Reporting drug, device problems to the FDA

If you have had a problem taking a medication, or a medical device has caused you harm, tell the FDA about it. The more information the FDA has about so-called adverse reactions the better. This information can be used to make new drugs and devices safer, and to caution other folks about using certain drugs or devices.

MedWatch is a vehicle for reporting serious adverse events arising from the use of an FDA-regulated drug, a biologic product (something made from human cells or tissues, and cellular and tissue-based products), a medical device (pacemaker, etc.), or a special nutritional product or cosmetics. You can submit a MedWatch form online, or call (toll free) 800-332-1088.

You can also file a report with a Consumer Complaint Coordinator. Coordinators are located in many, but not all, states. A list of coordinators for each state is available at the Consumer Complaint Coordinator Web page. You can also be directed to the correct one by calling the FDA's toll-free hot line at 888-463-6332 and choosing option #2.

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