Wednesday, April 22, 2009

Late 2008 - Adverse Drug Event Reports Reach Record Numbers

In 2008, one site reports that there were a record number of reports submitted to the US Food and Drug Administration (FDA) about serious injuries, disabilities, and deaths associated with drug therapy.

Almost 23,000 cases of serious ADEs—including 1,397 cases attributed to error—were reported to the FDA in April-June 2008, nearly 40% higher than the average of reported cases during the four quarters in 2007. The increase came about equally in reports originating from health professionals and consumers. Among the 23,000 ADEs were 2,968 deaths and 585 cases of disability or birth defects. The 2,968 reported deaths in this quarter declined from a record 4,824 deaths in the first quarter of 2008, but deaths remained substantially higher in 2008 than in 2007.

Source here.

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