Adverse Event Reporting and Contact Information
March 7, 2008
Where and How to Report an Injury, Side Effect and Other Adverse Events to the appropriate government agency.
Most government agencies responsible for issuing recall alerts on products that affect American consumers have contact forms that you can use to report adverse events. An "adverse event" can be loosely defined as a side effect, injury, death, or sickness related to a product, or a defect incident that has occurred which could possibly lead to a consumer or environmental health risk. Because each governmental agency defines such events in their own way, we suggest you contact them directly for more information and their "official" definitions.
In the meantime, here is how to contact each of the agencies to report an adverse event at the time of this writing:
American Citizens can comment on governmental regulations (including those listed below) and have their voice heard in the final decision-making process through the Regulations.gov website.
Contacting US Food and Drug Administration (FDA)
The FDA allows consumers to report dangerous food and drug products through their reporting system at MedWatch Online using form 3500 here.
Consumers should use alternative forms (found on the page above) to report adverse vaccine events, and side effects related to investigational (study) drugs. Consumers who wish to contact the FDA directly can do so at:
U.S. Food and Drug Administration
5600 Fishers Lane, Rockville MD 20857-0001
1-888-INFO-FDA (1-888-463-6332)
Contact United States Department of Agriculture
The USDA is contactable through their general feedback form here, or through the mailing address below:
U.S. Department of Agriculture
1400 Independence Ave., S.W.
Washington, DC 20250
Contact Environmental Protection Agency (EPA)
The EPA has several "Hotlines" that you can call, depending on what it is that you want to report. These Hotlines and Clearing houses can be found here. You can also get in touch with the EPA Headquarters in Washington, D.C. at the address below:
U.S. Environmental Protection Agency
Ariel Rios Building
1200 Pennsylvania Avenue, N.W.
Washington, DC 20460
Contact Consumer Product Safety Commission
The CPSC provides online forms for reporting unsafe products, which can be found here.
You may also contact the CPSC directly at (301) 504-7923 or by mail at:
U.S. Consumer Product Safety Commission
4330 East West Highway
Bethesda, MD 20814
Contacting the US National Highway Traffic Safety Administration
The NHTSA has jurisdiction over automobiles (cars, trucks, vans, motorcycles, etc.), tires, seatbelts, air bags, auto parts and other items related to traffic and vehicle safety. You may report a problem or adverse event with any of these by using their online form located here. The NHTSA is also contactable by phone through their DOT Vehicle Safety Hotline at 1-888-327-4236 or by snail mail at:
Office of Defects Investigations/CRD
NVS-216
1200 New Jersey Ave SE
Washington, DC 20590
Contacting the US Coast Guard for Marine Product Defect-Related Issues
The Coast Guard is responsible for regulating marine product safety, including the recall of floatation devices (life vests), boats and other marine-related products. You can report a safety defect by using one of these forms. We suggest you utilize the forms above first (since the safety division is a separate department) but if you need to contact the coast guard by mail you can do so at the address below:
Coast Guard Headquarters
Commandant, U.S. Coast Guard,
2100 Second Street, SW,
Washington, DC 20593
We suggest that consumers should ALWAYS contact the governing agency for more information about product recalls. Please read our disclaimer below.
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[...] of the date of this article there has not been a recall on BYETTA. However, if enough patients report side effects and/or confirmed cases of pancreatitis while taking BYETTA there may very well be a BYETTA recall [...]
I am a diabetes patient taking BYETTA. I have read several articles that state that BYETTA is linked to pancreatitis. I have taken BYETTA since 2006 and I have had abdominal pain accompanied by vomiting, which is the hallmark symtom of pancreatitis.
What should I do?