Reporting ADRs

The FDA has the responsibility for ensuring the safety of all marketed drugs; and, consequently, for maintaining a post-marketing surveillance program to identify ADRs. The success of this program depends on active participation by all clinicians. The FDA launched MedWatch, an initiative designed to educate health care professional about the critical importance of being aware of, monitoring for, and reporting ADRs.³⁸

It is of import to note that the reporting clinician is not responsible for proving causality; a suspected association constitutes sufficient reason to report. The FDA holds the identity of the patient in strict confidence. However, unless otherwise indicated on the reporting form, the reporting clinician’s identity may be shared with the manufacturer of the drug. Reports may be sent directly to the FDA by several different mechanisms:

• View Form FDA 3500 Instructions

  • Complete voluntary Form FDA 3500 online

  • Call 1-800-FDA-1088 to report by telephone

  • Download form or call 1-800-332-1088 to request a reporting form

    • Complete and return the form to the address on the pre-addressed form,

    • OR

    • Submit the form by fax to 1-800-FDA-0178

Based on these reports, the FDA may send out "Dear Health Professional" letters; require warning labels and/or changes to the packaging information (package insert); request further epidemiological investigations and/or manufacturer-sponsored post-marketing studies; and conduct inspections of manufacturers' facilities and/or records. Ultimately, the FDA may require withdrawal of the drug from the market.