New Safety Perspectives - May 2015

In this issue of QuarterWatch™, we examine why unsafe use of zolpidem (AMBIEN), a largely generic drug taken by more than 5 million people as a sleep aid, accounts for more emergency department visits for adverse effects than any other psychoactive drug.

Also, early signals for a new kind of diabetes drug, canagliflozin (INVOKANA) raise questions about whether enough is known about this agent to be assured that its benefits outweigh its risks.

Finally, a flood of low-quality manufacturer reports for another diabetes drug—rosiglitazone (AVANDIA)—provide a notable example of why the U.S. Food and Drug Administration (FDA) needs to modernize its essential postmarket surveillance reporting program.

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.