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Safety risks are defined as those that lead to withdrawal from the market due to safety concerns, a boxed warning, or FDA issuance of a safety communication. The median time for an FDA action to pose new safety risks or withdraw a drug after the drug already hit the market was 4.2 years after approval. The problem is that many clinical trials used for FDA approval involve fewer than 1,000 participants with follow-up of 6 months or less! Long-term side effects often crop up years later after drugs have been used by much larger numbers of people. Another part of the problem is that clinical trials often cherry-pick participants likely to produce the best results, which is not representative of the entire population. One out of three drugs posing safety concerns after they have been deemed safe is alarming. It seems as though the process of approving drugs needs to be revised including more comprehensive clinical trials with a longer follow-up and more participants. Since it takes the FDA about 4 years to identify safety concerns after a drug has been on the market, perhaps a clinical trial investigating a new drug needs a follow-up of 4 years to determine how safe it is in the first place.

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