Why do some safety issues arise after a drug has already been approved for marketing?
A. FDA is always learning new information about a drug once it has been approved for sale and is in general use. Common side effects or risks of a drug are usually clear when a drug is approved. But clinical trials, which typically study several thousand people, don’t reveal all of the risks. A rare problem may only come to light after the drug is used in millions of people in the larger population. The fact that FDA commonly observes new or more frequent side effects is why the agency continues to evaluate drugs after they are approved. Post-marketing surveillance is one way to monitor a drug’s safety on an ongoing basis. After a drug is approved, long-term safety studies and additional clinical trials also may be conducted and evaluated. Q. Where do post-marketing safety reports come from? A. Most post-marketing safety reports are submitted to the drug manufacturer by physicians, nurses, pharmacists and other health care providers. In turn, the company assesses these reports and is r
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