QuarterWatch® Reports

Signals for Varenicline, Levofloxacin and Fentanyl

In this issue of QuarterWatch™: A year after the FDA required new safety measures, varenicline (CHANTIX) continued to account for large numbers of three reported serious psychiatric side effects.

We analyze why levofloxacin (LEVAQUIN) had more reports of serious injury than other antibiotics. 

Maladministration of fentanyl patches were a prominent safety issue featured in a new section, Drug Safety Perspectives.

We also update findings on Johnson & Johnson’s OTC product recalls and describe new safety questions about the heart drug dronedarone (MULTAQ).

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.