According to a report published this month in the Archives of Internal Medicine, serious and fatal adverse drug events (ADEs) reported to the FDA’s Adverse Event Reporting System (AERS) have more than doubled in the period 1998–2005. Established in 1998, the AERS receives ADE reports from the FDA and drug manufacturers. Serious ADEs increased by a factor of 2.6 between 1998 and 2005 to 89,842, while fatal ADEs increased by a factor of 2.7 to 15,107. Pain medications and immune system modulators had a high frequency of involvement with fatal ADEs. Of the drugs linked to ADEs, 20% accounted for 87% of the events. Serious ADEs linked to 13 new biotech drugs increased by a factor of 15.8, from 580 events in 1998 to 9,181 in 2005. The authors of the report argue that systems for the risk management of prescription drugs need to be improved.

Source: Medscape Medical News

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