We Need to Report Serious Adverse Events or Serious Drug Side Effects to the FDA – How You Can Make a Report

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 p