Reporting Adverse Drug Reactions To The FDA MedWatch Program

FDA MedWatch Program

MedWatch is an FDA program for reporting “serious reactions” resulting from a prescription medication. The FDA is particularly interested in those drug injury events which resulted in any of the following outcomes:

Patient’s Death: an adverse reaction to a drug is the suspected cause of death
Life-Threatening Condition: a serious side-effect put the patient at real risk of dying
Hospitalization: the person is admitted to the hospital because of their serious adverse reaction to a medication
Permanent Disability: strokes; nervous system disorders; other impairment
Birth Defect or Birth with Disease: congenital anomaly; adverse outcome to a child
Needs Medical Intervention to Avoid Permanent Damage: medical treatment is required

How to File a MedWatch Report

The FDA encourages patients to take the Reporting Form to their treating doctor when it is known or suspected that they have been seriously harmed by a pharmaceutical product. However, it is important to understand that this physician is not required to make a report to the FDA, even if you ask them to do so.

For this reason, and because there may be circumstances when a person does not want to go back to their doctor to ask for help with a drug injury report, patients can submit their information directly to the FDA. There is an online reporting form available through the FDA website.

To report online, you can use the MedWatch Online Voluntary Reporting Form (3500).

Form FDA 3500B (a PDF form that can be filled out online) is a consumer-friendly voluntary reporting form that contains less technical language than the online FDA Form 3500.

MedWatchLearn is a web-based learning tool designed to educate medical students, doctors or other health professionals, and consumers on reporting in a way that provides the best information for FDA reviewers to further investigate medical product problems.

Lastly, you can use the toll-free telephone number for reporting a suspected drug injury to the FDA: 800-FDA-1088.

Be assured that the patient’s identity will be held in strict confidence by the FDA. In addition, the FDA will not disclose the identity of the person who submitted the report, be it the doctor, the patient, a family member, a health care provider, or some other concerned person.

FDA Adverse Event Reporting System

The United States Food and Drug Administration (US FDA) has established a drug safety database known as the FDA Adverse Event Reporting System (AERS).

The basic information stored in the AERS is taken from the Individual Safety Report (ISR), which contains all of the information contained on the MedWatch form (FDA Form 3500 or FDA Form 3500A). ISRs can be submitted to the FDA by consumers, healthcare providers, and drug manufacturers. A real limitation to the database, however, is under-reporting. One study found that only 1% of serious adverse events are reported to the FDA.