Reporting Side Effects from Drugs and Medical Devices to the Food and Drug Administration

Consumers can play an important role in protecting the public health by reporting to the Food and Drug Administration (FDA) the serious health problems they experience while taking prescription drugs and dietary and herbal supplements or while using medical devices.

Consumers should consider reporting serious reactions and problems to the FDA when the outcome is:

Death. Report if the patient’s death is suspected as being a direct outcome of the use of the drug, supplement or medical device.

Life-Threatening. Report if the patient was at substantial risk of dying from the adverse reaction or it is suspected that the use or continued use of the product would result in the patient’s death. Life-threatening examples include pacemaker failure, gastrointestinal hemorrhage (stomach or intestines) and inability to produce new blood cells. Another life-threatening reaction could result from infusion pump failure, which permits uncontrolled free flow of the drug into the blood stream and can result in excessive dosing.

Hospitalization (initial or prolonged). Report if admission to the hospital or a prolonged hospital stay results from the use of the drug, supplement or device. Examples include a severe allergic reaction, acute inflammation of the colon (which is usually induced by antibiotics) and bleeding.

Disability. Report if the adverse event resulted in a significant, persistent or permanent change in the patient’s body function/structure, physical activities or quality of life. Examples include a stroke due to either a drug-induced increase in the tendency for the blood to clot and drug-induced bleeding and peripheral neuropathy (nerve problems).

Congenital Anomaly (birth defects). Report if there are suspicions that exposure to a medical product prior to conception or during pregnancy resulted in birth defects in the child. Examples include vaginal cancer in female offspring from use of the synthetic non-steroidal estrogen diethylstilbestrol (DES) during pregnancy and malformation in the offspring caused by the anti-nausea medication thalidomide.

Danger of Permanent Impairment or Damage. Report if you suspect that the use of a medical product may result in a condition that requires medical or surgical intervention to preclude permanent impairment or damage to a patient. This could be acetaminophen (Tylenol) overdose-induced liver damage requiring treatment with the drug acetylcysteine (ACC, Mucomyst, Acetadote, Fluimucil and Parvolex) to prevent permanent damage.

Other examples include burns from radiation equipment requiring drug therapy and breakage of a screw used to aid in the healing of a fractured long bone requiring replacement of a medical device.

Product problems should also 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 products
• Product contamination
• Defective components
• Poor packaging
• Product mix-up
• Questionable stability
• Device malfunctions
• Labeling concerns

What You Can Do

Individuals can report their serious drug or device reactions and problems to FDA’s MedWatch program. The FDA offers several ways for consumers or health professionals to submit MedWatch reports:

• Go to the MedWatch Web site at:
https://www.accessdata.fda.gov/scripts/medwatch/medwatch-online.htm and follow the instructions for submitting a report electronically.

• Fill out and mail the MedWatch form to the FDA:

MEDWATCH
The FDA Safety Information and Adverse Event Reporting Program
Food and Drug Administration
5600 Fishers Lane
Rockville, MD 20852-9787

• Submit a completed form to Med-Watch’s fax at 1-800-332-0178.

• Call the FDA’s toll-free reporting number at 1-800-FDA-1088.