STAT Plus: What side effects? Problems with medicines may be vastly underreported to the FDA
It’s no secret that the many side effects caused by medicines do not get reported to the Food and Drug Administration, but a new report suggests the magnitude of underreporting is far greater than imagined.
After examining side effects that were conveyed to the regulator for five widely used medicines — two different types of arthritis treatments, an antipsychotic, and a blood thinner — just 1% of an estimated 276,000 serious adverse events had been reported in 2017.
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