Consumer Drug Related Injuries and Deaths More Than Doubled Between 1998 and 2005

A study recently published in the Archives of Internal Medicine reports that serious adverse drug events reported to the FDA more than doubled  between 1998 and 2005.  As defined by the FDA, serious adverse drug events involve drug reactions that “result in death, birth defect, disability, or hospitalization, or are otherwise life threatening or require intervention to prevent harm.”

Focusing on cases identified through the FDA’s Adverse Event Reporting System, a post-marketing safety program for FDA-approved drugs, the study’s authors found that the number of reports of serious adverse drug events  increased from 34,966 in 1998 to 89,842 in 2005.  In particular, the number of fatalities almost tripled over the same period, from 5,519 to 15,107.  Notably, although a total of 1,489 FDA-approved drugs were associated with adverse events, a small subgroup of 51 drug products accounted for 43.6% of adverse event reports within the 1998-2005 period.

An abstract of the study can be found at the Archives of Internal Medicine website by clicking here.