Reporting a Drug to FDA's MedWatch: What You Need To Know
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To ensure the safety and efficacy of all regulated and marketed drugs, the FDA created MedWatch. This program allows consumers to report serious reactions or quality problems with drugs. The goal is to provide both the medical community and the general public with important and timely information about drug safety issues including safety alerts, recalls, withdrawals, and labeling changes that may affect people's health. If you or someone you love has experienced a serious adverse reaction to an FDA-regulated drug, you are encouraged to report this event to the FDA's MedWatch program.
Guidelines for Reporting
MedWatch defines a serious adverse reaction as any "undesirable experience" associated with a patient's use of the drug. A reaction is deemed serious if it results in:
- Death
- Life-threatening injury or illness
- Hospitalization
- Disability
- A congenital anomaly
- Intervention to prevent permanent impairment or damage
To report a serious adverse event, download the report form available on the MedWatch website . You are encouraged to submit your report through your healthcare provider, as they may be able to provide MedWatch with helpful medical information. You can also submit a report without going through your doctor by simply filling out MedWatch's online reporting form.
If you have suffered a serious adverse reaction to an FDA-regulated drug, you can report this event to MedWatch. By reporting a serious side effect, you are not only helping yourself but others as well.
If you have been seriously injured by a pharmaceutical drug, you may also wish to contact a qualified attorney with experience handling cases of drug-related injuries and death. You may be eligible to seek compensation for your losses and suffering. Please click here for more information.
For more on Consumer Drug Safety click here.
