Special Communications Introducing MEDWatch A New Approach to Reporting Medication and Device Adverse Effects and Product Problems

fessionals do not think to report adverse events that might be associated with medications or devices to the Food and Drug Administration (FDA) or to the manufacturer. That needs to change, and the FDA is taking steps to encourage that to happen. Reports from health professionals of adverse events or product quality prob lems are essential to ensure the safety of drugs, biologicals, medical devices, and other products regulated by the FDA once they are introduced into the US market. Even the large, well-designed clinical trials that are conducted to gain pre market approval cannot uncover every problem that can come to light once a product is widely used. A new drug ap plication, for example, typically includes safety data on several hundred to sev eral thousand patients. If an adverse event occurs in perhaps one in 5000 or even one in 1000 users, it could be missed in clinical trials but pose a serious safety problem when released to the market. Moreover, patients taking marketed drugs in conjunction with other drugs may experience interactions not re vealed during the premarketing phase. I In response to voluntary reports from physicians to the FDA or the manufac turer, the FDA has issued warnings, made labeling changes, required man ufacturers to conduct postmarketing studies, and ordered product withdraw als that have ultimately prevented pa tient deaths and suffering. Adverse drug reports from physicians, for example, prompted the FDA to de termine that torsades-de-pointes ven