How to Report Adverse Effects from Drugs and Medical Devices to the FDA

MedWatch is the Food and Drug Administration’s program for reporting serious adverse drug reactions and problems with medical products to the government. In 2004, the MedWatch program received 422,889 reports of suspected adverse reactions involving drugs. Of these, about 21,000 reports came directly from the public. 

The United Kingdom has recently begun a similar program. Consumers are now encouraged to report adverse experiences to the British drug regulatory authority.

Consumers can play an important public health role by reporting adverse experiences to the FDA, particularly serious ones, with drugs, medical devices or dietary and herbal supplements.  

What to Report

The FDA considers an adverse event as serious and one that should be reported when the outcome is:

Death:  The patient’s death is suspected of being a direct outcome of the adverse event.

Life-Threatening:  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 of life-threatening events are: pacemaker failure; gastrointestinal hemorrhage (bleeding); bone marrow suppression (toxicity); and infusion pump failure, which permits uncontrolled free flow of a drug, resulting in excessive drug dosing.

Hospitalization:  Admission to the hospital or prolongation of a hospital stay results from the adverse events.

Examples of reportable hospitalization are:  anaphylaxis (severe allergic reaction); pseudomembranous colitis (inflammation of colon, usually induced by antibiotics); and bleeding causing or prolonging hospitalization.

Disability:  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 of disability are: stroke due to drug-induced hypercoagulability (higher tendency for blood to clot); and peripheral neuropathy (diseased or degenerative state of nerves).

Congenital Anomaly:  There are suspicions that exposure to a medical product prior to conception or during pregnancy resulted in an adverse outcome in the child.

Examples of congenital abnormalities:  Vaginal cancer in female offspring of mothers taking diethylstilbestrol (DES) during pregnancy and malformation in the offspring caused by thalidomide.

Requires Intervention to Prevent Permanent Impairment or Damage:  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 liver damage requiring treatment to prevent permanent damage; burns from radiation equipment requiring drug therapy; and 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:

• suspected 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 consumers or health professionals to submit MedWatch reports:

Online — Go to the MedWatch Web site at www.fda.gov/ medwatch/and follow the instructions for submitting a report

By mail — Fill out and mail the MedWatch form to the FDA

By phone — The toll-free number is 1-800-FDA-1088

By fax — You can fax a completed form to 1-800-FDA-0178.

The reporting form is available at www.fda.gov/medwatch/SAFETY/3500.pdf.