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Health Center » In The News » FDA Questions of the Week

How do I report a bad reaction related to drugs, biological products, medical devices, etc?

February 03, 2006

 

Answer:

FDA created the MedWatch program to monitor adverse effects and problems with medical products the agency regulates (human drugs and medical devices, for example). MedWatch is a voluntary reporting system available to consumers or health professionals by going to http://www.fda.gov/medwatch/index.html. Click on "How to Report", then "Reporting by Consumers" or "Reporting by Health Professionals." You also can call the FDA Division of Drug Information at 301-827-4573 and request that a MedWatch Voluntary Reporting Form be sent to you.
To report adverse reactions or other problems with food (except meat and poultry), contact the FDA district office consumer complaint coordinator for your geographic area. A list is at http://www.fda.gov/opacom/backgrounders/complain.html.  For problems with meat and poultry, which the U.S. Department of Agriculture regulates, call 1-800-535-4555.
For problems with vaccines, FDA and the Centers for Disease Control and Prevention maintain the Vaccine Adverse Event Reporting System. To report a vaccine problem online, go to https://secure.vaers.org/VaersDataEntryintro.htm.
For more on reporting problem products to FDA, go to http://www.fda.gov/opacom/backgrounders/problem.html.

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