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Consumers can play an important public health role by reporting any adverse experiences with drugs, devices, or dietary and herbal supplements to the Food and Drug Administration (FDA). This can be done through the MedWatch program, the FDA’s medical products reporting system. The FDA emphasizes that it is not necessary to prove that a medical product caused an adverse reaction — a suspected association is sufficient reason to make a report to the agency.
The FDA is particularly interested...
Consumers can play an important public health role by reporting any adverse experiences with drugs, devices, or dietary and herbal supplements to the Food and Drug Administration (FDA). This can be done through the MedWatch program, the FDA’s medical products reporting system. The FDA emphasizes that it is not necessary to prove that a medical product caused an adverse reaction — a suspected association is sufficient reason to make a report to the agency.
The FDA is particularly interested in suspected adverse events that led to the following outcomes:
- Death
- Life-threatening hazard
- Hospitalization
- Disability
- Birth defects, miscarriage, stillbirth, or birth with disease
- Needs intervention to avoid permanent damage
The FDA offers several ways for health professionals or consumers to submit MedWatch reports:
- Online — Go to the MedWatch Web site at www.fda.gov/medwatch/ and follow the instructions for submitting a report electronically
- By mail — Print out the form from the Medwatch site and mail it
- By phone — The toll-free number for reporting to the FDA is 1-800-FDA-1088
- By fax — You can submit a completed form to MedWatch’s fax number at 1-800-332-0178
