When a drug does serious harm, the FDA wants to hear from you

I frequently lecture to physicians, pharmacists, and other healthcare professionals on drug safety, and I often start by asking how many people have ever observed a serious adverse drug event. Almost everyone in the room raises his or her hand. I then ask how many have ever reported a serious adverse drug event to the US Food and Drug Administration (FDA) or to a drug company, and almost all of the hands go down. Often, healthcare providers do not know the important role that they can play in drug safety surveillance. Even less well known is that consumers can also contribute directly to enhancing drug safety surveillance by reporting adverse drug events that they personally have experienced. What is a serious adverse event? The FDA describes an adverse event as “any undesirable experience associated with the use of a medical product” (this includes medical devices as well as drugs). A serious adverse event is one that is life-threatening, requires hospitalization, results in permanent damage or disability (including birth defects), or that jeopardizes the health or life of the person using it in some other way. The FDA’s role in drug safety The FDA is responsible for regulating many of the products we use every day, from foods and cosmetics to dietary supplements and medical devices. It is also in charge of assuring the safety and effectiveness of medicines. This includes approving prescription drugs that have been proven to work after a series of rigorous studies, as ...
Source: Harvard Health Blog - Category: Consumer Health News Authors: Tags: Drugs and Supplements Health Managing your health care Source Type: blogs