Adverse Drug Events Reporting Systems

Every drug carries some potential risk. The question is if the benefits outweigh the risks. If society allowed marketing only of completely safe drug products, drug approval would likely take decades and few if any new drugs would be available. That is why besides reviewing drugs before approving them, the U.S. Food and Drug Administration (FDA), which remains responsible for safety as long as a drug is on the market, conducts subsequent monitoring for adverse effects, defined as any undesirable experience associated with the use of a medical product. Besides drugs, FDA also monitors medical devices, dietary supplements, cosmetics, medical foods, and infant formulas, using similar methods as for drugs. Vaccines have their own safety surveillance program, the Vaccine Adverse Event Reporting System. This article ...