FDA Received 20,745 New Cases of Serious InjuriesKNN-Staff
A record number of deaths and serious injuries associated with prescription drugs were reported in the first quarter of 2008.
The U.S. Food and Drug Administration received 20,745 new cases of serious injuries during the first quarter, an increase of 38 percent over 2007. The number of deaths reported is 4,824, a 2.6-fold increase from the previous quarter.
For a second straight quarter, varenicline (Chantix, Champix), an aid to help stop smoking, accounted for more reported serious injuries than any other prescription drug, with a total of 1,001 new cases including 50 deaths, according to The Institute for Safe Medication Practices, an organization that educates healthcare providers and consumers about safe medication practices.
Ranked second in reported serious injuries was the blood thinner heparin, the subject of a major product recall after a potentially lethal contaminant was identified and traced to suppliers in China.
In the first quarter of 2008, the FDA received 779 reports of serious injury in which heparin was the principal suspect drug, including 102 deaths, the institute reported.
Acetaminophen, which had 160 reported deaths, and ibuprofen, with 114 reported deaths, are two of the most widely used drugs in the nation.
The findings in QuarterWatch are developed from analyzing new adverse drug event reports submitted to the FDA Adverse Event Reporting System.
Because reporting is voluntary, only a small fraction of adverse drug events that occur are reported to the FDA, or to drug manufacturers, which then investigate and forward reports to the agency. Also, while the sum of adverse event reports normally provides an overall adverse event profile for a drug, the individual reports themselves do not prove that the drug caused the event described, the institute said in its report.
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