NCPA - National Center for Policy Analysis


September 11, 2007

Reports of serious injuries and deaths that may have been caused by prescription drugs skyrocketed between 1998 and 2005, but it's unclear if the jump in reports to Food and Drug Administration (FDA) reflects a true increase in the number of people who suffered serious side effects, according to a paper published in the Archives of Internal Medicine.


  • 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.

However, the rise can't be explained by an increase in the use of medicines:

  • The number of serious adverse events reported rose four times as fast as prescriptions in the period.
  • In addition, the jump wasn't driven by a few high-profile drug problems, such as Merck's withdrawal of painkiller Vioxx in 2004 and Pfizer's suspension of rival painkiller Bextra in 2005.


  • The increase was largely explained by reports from manufacturers; and those reports were mainly about side effects not already described on drugs' labels.
  • Reports directly from doctors and pharmacists to the FDA, as well as reports from drug companies of side effects already on drug labels, rose much more slowly; a disparity the authors were unable to explain.

The bigger issue is that the FDA's Adverse Event Reporting System isn't a systematic measure of how often drugs really cause side effects.  Doctors aren't required to report drug side effects into the system, and it's been estimated as few as 10 percent of all adverse events get reported. So it's tough to draw any firm conclusions about what the data from the system mean.

Source: Jacob Goldstein, "More Drug Side Effects, or Just More Reports of Problems?" Wall Street Journal, September 11, 2007.

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