Reporting Adverse Events From Drugs and Medical Devices To The Food and Drug Administration

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

Individuals can report their serious drug or device reactions and problems to FDA’s MedWatch program.

Consumers should consider reporting these serious drug 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 and gastrointestinal hemorrhage (stomach or intestinal bleeding).

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) or 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 drug-induced increase in the tendency for the blood to clot or drug-induced bleeding and peripheral neuropathy (nerve problems).

Congenital Anomaly: 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 or 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. Examples include acetaminophen (TYLENOL) overdose-induced liver damage requiring treatment with the drug acetylcysteine to prevent permanent damage, burns from radiation equipment requiring drug therapy or 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 or product mix-up
• questionable stability
• device malfunctions
• labeling concerns

What You Can Do

There are four ways to submit a MedWatch report:

• Online: www.fda.gov/medwatch/
• Mail:  FDA-MedWatch
  5600 Fishers Lane
  Rockville, MD 20852-9787
• Fax:  1-800-332-0178
• Phone:  1-800-FDA-1088