Record Number of Serious Problems, Deaths Linked to Medications

A record number of deaths and serious injuries associated with drug therapy were reported to the U.S. Food and Drug Administration (FDA) in the first quarter of 2008. Serious injuries associated with drug therapy reached a total of 20,745 new cases; reported deaths totaled 4824 cases, a 2.6 fold increase from the previous quarter. In addition, varenicline (Chantix, Champix), an aid to stopping smoking, accounted for more reported serious injuries than any other prescription drug for a second quarter, a total of 1001 new cases, including 50 additional deaths. Varenicline was the subject of a previous Quarter Watch special report1 and a separate FDA Public Health Alert about psychiatric side effects. Ranked second in reported serious injuries was heparin, a drug that helps prevent injury from blood clots. Heparin was 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 reports of 779 cases of serious injury in which heparin was the principal suspect drug. These findings come from a program being developed by the Institute for Safe Medication Practices (ISMP) to improve patient safety through increasing our understanding of how and why drug-related injuries and medication errors occur. The results come from analyzing new adverse drug events reports submitted to the FDA. The agency releases computer excerpts of these reports for research use after personalidentifying information has been removed.