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.
Meanwhile, the FDA receives approximately 400,000 reports each year from patients, physicians, and drug manufacturers, which implies that as many as 4 million people experienced a serious or fatal injury that was suspected to have been connected with a medication, according to the report from the Institute for Safe Medicines Practices, a nonprofit that acts as a watchdog for prescription drug safety.
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I noted the same arithmetic issue but the factor is 100, not 1,000. That implies 40 million events.
The report seems to imply only one of one thousand AE’s are reported. On that basis, the number FDA gives should actually be closer to 4 billion events. Our scribes report of millions seems comfortingly realistic.