QuarterWatch® Reports

New Signals for Liraglutide, Quetiapine and Varenicline

In this issue of QuarterWatch™ we take a look at the new diabetes drug liraglutide (VICTOZA), which was approved in January 2010 after a debate at the FDA over its safety profile. We examine a signal for pancreatitis for liraglutide, and compare it to other chemically-related drugs.

A growing number serious adverse event reports for quetiapine (SEROQUEL) were associated in part with its expanding use as a general psychiatric treatment outside its core indication for psychosis.

A major adverse event reporting problem with varenicline (CHANTIX) led to its risks of psychiatric side effects—including completed suicide—being underestimated in adverse event data.  We also ask the FDA to investigate Pfizer’s handling of 150 cases of completed suicide and scores of suicide attempts associated with varenicline.

QuarterWatch™ is an independent publication of the Institute for Safe Medication Practices (ISMP). We analyze computer excerpts from the U.S. 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.