Why would FDA approve a drug if it has risks?
A. All drugs approved for sale in the United States by FDA must prove that they have beneficial effects on the body by curing disease, controlling disease, preventing disease or relieving symptoms. But all drugs also have side effects or risks: most are minor; some can be serious or rarely even life-threatening. FDA’s job is to balance a drug’s benefits against the risks for the drug’s intended use. The agency approves a drug only after determining that the benefits outweigh the risks for most people, most of the time. Q. What factors does FDA consider when weighing a drug’s benefits and risks? A. FDA considers how the drug will be used and who will be using it: Will the drug be used for a serious life-threatening condition like cancer, or to prevent or forestall serious complications from diseases like diabetes, or conditions such as high blood pressure or elevated blood cholesterol? Will the drug be used most often by older people or children? Is it likely that other medicines will b
