The Food and Drug Administration (FDA) is charged with protecting the general health and well being of Americans with medicines and certain treatment equipment. Sometimes these medications or treatment equipment fail, don’t work as indicated or cause serious, life threatening side effects. Reporting these events is important so the FDA can track and monitor these issues allowing them to further evaluate the safety and efficacy of a product.
The Food and Drug Administration’s (FDA) has a program called MedWatch which is designed to report:
1- Serious Reactions
2- Product Quality Problems
3- Therapeutic Failure
4- Product Use Errors
5- Human Medical Products
The reporting of negative side effects should include problems with drugs, biologic products, medical devices, dietary supplements, infant formula, and cosmetics.
If you believe that you or someone in your family has experienced a serious reaction to any medical product, you should take the reporting form to your healthcare provider and ask for their help in filling it out. Your healthcare provider can provide clinical information based on your medical record that can help the FDA evaluate your report.
If you wish not to include your healthcare provider in making a report or if your healthcare provider elects not to complete the report you may complete the Online Reporting Form yourself.
Once you have submitted the form and the FDA receives it you will receive an acknowledgement from them. The FDA staff reviews all reports no matter who submitted them. You will be personally contacted only if the FDA needs additional information.
Submitting Adverse Event Reports to the FDA Use one of the methods below to submit voluntary adverse event reports to the FDA:
1. Report Online
2. Consumer Reporting Form FDA 3500B. Follow the instructions on the form to either fax or mail it in for submission. For help filling out the form, see MedWatchLearn.
3. Call the FDA at 1-800-FDA-1088 to report by telephone
4. Reporting Form FDA 3500 commonly used by health professionals. View Instructions for Form FDA 3500
For more information on reporting adverse effects go to the FDA website at:
Joel T. Nowak, M.A., M.S.W.