Healthy Skepticism Library item: 11515

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Publication type: Journal Article

Spurgeon D.
Number of serious adverse events doubles in seven years in US
BMJ 2007 Sep 22; 335:(7620):585
http://www.bmj.com/cgi/content/short/335/7620/585-a?etoc

Abstract:

The number of reported serious adverse events from drug treatment more than doubled in the United States from 1998 to 2005, rising from 34 966 to 89 842, says a new study.

Over the same period the number of deaths relating to drugs nearly tripled, from 5519 to 15 107, show data from the US Food and Drug Administration’s adverse event reporting system, which collects all reports of adverse events submitted voluntarily to the agency either directly or through drug manufacturers (Archives of Internal Medicine 2007;167:1752-9).

Using extracts from the system that were published for use by researchers, the study’s authors-Thomas Moore and Michael Cohen, of the Institute for Safe Medication Practices at Wake Forest University, Winston-Salem, North Carolina, and Curt Furberg, of the university’s public health sciences division-analysed all adverse drug events and treatment errors reported to the agency from 1998, when the FDA started operating the system, . . .