
Reporting drug, device problems to the FDA
NOV 2010
Did you know?
You can get instant online access to all of the articles from the November 2010 issue of Harvard Heart Letter for only $5.
Already a subscriber? Login for complete instant access.
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.
