What is MedWatch?
MedWatch allows consumers to report serious problems that they suspect are associated with the drugs and medical devices they use. Reporting can be done on line, by phone, or by submitting the MedWatch 3500 form by mail or fax. When the FDA does a post marketing review of drugs for safety, they gather information from clinical trials and MedWatch reports. Unfortunately, when people have adverse reactions to drugs, their prescribing physicians don’t like to file MedWatch reports. As a result, the FDA is often unaware of the level of risks associated with the drugs that they have sanctioned safe for the American public. You can help. If you or your loved ones have ever had an adverse reaction to a drug, file a MedWatch report. Adverse events include: suicide, suicidal thoughts, unusual aggressiveness, hallucinations, psychotic behavior, lack of growth, stroke, elevated heart rate, or any concerning side effect.