How You Can Report Adverse Reactions to the Food and Drug Administration

Consumers can play an important public health role by reporting to the Food and Drug Administration (FDA) any adverse experience with drugs and medical devices, including dietary and herbal supplements. This can be done through MedWatch, the FDA’s medical products reporting program.

The MedWatch program played major roles in decisions to remove the painkilling drug bromfenac (DURACT) from the market following reports of deaths and liver injuries. The FDA also moved to withdraw the blood pressure treatment mibefradil (POSICOR) after learning of drug interactions that led to serious adverse reactions.

The FDA encourages patients or their family members to ask their doctor to make the report because he or she can provide clinical information based on your medical record that can help the FDA to evaluate the report. There may be a variety of reasons that you do not wish to have the form filled out by your doctor or your doctor may choose not to complete the form. Doctors are not required to report adverse events to the FDA.

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—If an adverse reaction to a medical product is a suspected cause of a patient’s death.
• Life-threatening hazard—If the patient was at risk of dying at the time of the adverse reaction or if it is suspected that continued use of a product would cause death. A pacemaker breakdown or the failure of an intravenous (IV) pump that could cause excessive drug dosing are examples.
• Hospitalization—If a patient is admitted or has a prolonged hospital stay because of a serious adverse reaction. For example, a serious allergic reaction to a product such as latex.
• Disability—If the adverse reaction caused a significant or permanent change in a patient’s body function, physical activities, or quality of life. Examples of this type of outcome would be strokes or nervous system disorders brought on by drug treatment.
• Birth defects, miscarriage, stillbirth, or birth with disease—If exposure to a medical product before conception or during pregnancy is suspected of causing an adverse outcome in the child such as a malformation in the child caused by the acne drug isotretinoin (ACCUTANE).
• Needs intervention to avoid permanent damage—If use of a medical product required medical or surgical treatment to prevent impairment (examples: burns from radiation equipment or breakage of a screw supporting a bone fracture).

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—Use the MedWatch form which includes the address.
• 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.