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Category Archives: fda modernization act

More Drug Side Effects, or Just More Reports of Problems?

clipped from blogs.wsj.com

Reports of serious injuries and deaths that may have been caused by prescription drugs skyrocketed between 1998 and 2005, says a paper published today in the Archives of Internal Medicine. But it’s unclear if the jump in reports to FDA reflects a true increase in the number of people who suffered serious side effects.

First, the numbers. In 1998, the FDA received 34,966 reports of serious adverse events, including 5,519 reports of deaths, possibly related to the use of prescription drugs. By 2005, those figures more than doubled, to 89,842 events including 15,107 deaths.

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