How does FDA monitor the safety profile of a drug after it is approved?
FDA continually gathers and learns more about a product’s benefits and risks even after it is on the market. Benefits and risks depend on many different factors and can be different in different people. Some of the factors that the FDA, doctors and patients consider, include: • the severity of the disease being treated, in general and the individual patient’s case • the outcome of the disease if it is not treated • the likelihood and degree of benefit from the drug • other treatment options, if any, and their risks and benefits • how easy it may be for patients to use the drug according to directions • the concerns of each individual patient (some patients might find a particular risk or side effect to be not very bothersome while others might suffer greatly from the same side effect) Thus, assessment and comparison of a product’s benefits and risks is a complicated process that is influenced by a wide range of societal, healthcare, and individualized patient factors. Once a drug is ap
