QuarterWatch® Reports

Reported Patient Deaths Increased by 14% in 2009

In this issue of QuarterWatch™:  In the full year of 2009 reported patient deaths associated with drug therapy increased by 14% compared to 2008, and were up 3-fold since 2000. Three factors contributed to the increase:

  • higher awareness of drug risks increased reports for drugs such as rosiglitazone and digoxin,
  • risks for some high-alert drugs continued unabated, and
  • more drug company contact with consumers led to reporting problems.

We also examine Johnson & Johnson’s massive recall of Tylenol products and reports of problems with that company’s fentanyl patches.

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.