Reporting Adverse Events With Drugs and Medical Devices to the Food and Drug Administration

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). MedWatch is the FDA’s program for reporting serious reactions and problems with medical products. The FDA considers an event as serious and one that should be reported when the outcome is:

Death

Report if the patient’s death is suspected as being a direct outcome of the adverse event.

Life-Threatening

Report if the patient was at substantial risk of dying at the time of the adverse event or it is suspected that the use or continued use of the product would result in the patient’s death.

Examples: Pacemaker failure; gastrointestinal hemorrhage (bleeding); bone marrow suppression (toxicity); infusion pump failure which permits uncontrolled free flow resulting in excessive drug dosing.

Hospitalization (initial or prolonged)

Report if admission to the hospital or prolongation of a hospital stay results because of the adverse event.

Examples: Anaphylaxis (severe allergic reaction); pseudomembranous colitis (inflammation of colon usually induced by antibiotics); or bleeding causing or prolonging hospitalization.

Disability

Report if the adverse event resulted in a significant, persistent, or permanent change, impairment, damage or disruption in the patient’s body function/structure, physical activities or quality of life.

Examples: Cerebrovascular accident (stroke) due to drug-induced hypercoagulability (higher tendency for blood to clot); toxicity; peripheral neuropathy (disease or degenerative state of nerves).

Congenital Anomaly

Report if there are suspicions that exposure to a medical product prior to conception or during pregnancy resulted in an adverse outcome in the child.

Examples: Vaginal cancer in female offspring from diethylstilbestrol (DES) during pregnancy; malformation in the offspring caused by thalidomide.

Requires Intervention to Prevent Permanent Impairment or Damage

Report if you suspect that the use of a medical product may result in a condition which requires medical or surgical intervention to preclude permanent impairment or damage to a patient.

Examples: Acetaminophen (Tylenol) overdose-induced hepatotoxicity (liver damage) requiring treatment with the drug acetylcysteine to prevent permanent damage; burns from radiation equipment requiring drug therapy; breakage of a screw requiring replacement of hardware to aid in the healing of a fractured long bone.

Product problems should be reported to the FDA when there is a concern about the quality, authenticity, performance, or safety of any drug or device.

Problems with product quality may occur during manufacturing, shipping, or storage. They include:

• suspect counterfeit product;
• product contamination;
• defective components;
• poor packaging or product mix-up;
• questionable stability;
• device malfunctions; and
• labeling concerns.

What You Can Do

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 — Fill out and mail the MedWatch form to the FDA

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