QuarterWatch™ Reports January 2012

Signals for Dabigatran (PRADAXA) and Metoclopramide (REGLAN)

This issue of QuarterWatch™ examines a strong signal for serious bleeding with the new anticoagulant drug dabigatran (PRADAXA) and investigates reports of brain damage associated with metoclopramide (REGLAN), a drug for reflux and other gastrointestinal disorders.

In addition, we review the quarterly data for the five most widely prescribed drugs in the United States, revealing results that reflect upon the safety of the most popular and essential drugs as well as providing a perspective on how the monitoring system works.


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.