QuarterWatch® Reports

Anticoagulants the Leading Reported Drug Risk in 2011

In this issue of QuarterWatch™, we examine the most frequently identified suspect drugs in direct reports to the U.S. Food and Drug Administration (FDA) for the calendar year of 2011. Based on our analysis of a full year of reports to the FDA the anticoagulants dabigatran (PRADAXA) and warfarin (COUMADIN) rank among the highest risks in prescription drug therapy.

In addition, we identified nine other drugs associated most frequently with five clinically relevant, drug-related injuries, and show the drugs most frequently the target of lawsuits.

QuarterWatch™ is an independent publication of the Institute for Safe Medication Practices (ISMP). We analyze computer excerpts from the US Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS). These reports (best known as MedWatch reports) are a cornerstone of the nation’s system for monitoring the safety of prescription drugs after FDA marketing approval.