QuarterWatch® Reports

Why Reports of Serious Adverse Drug Events Continue to Grow

In this QuarterWatch™ report we analyze signals for duloxetine (CYMBALTA) and serious withdrawal symptoms; pioglitazone (ACTOS) and reported bladder cancer; aliskiren (TEKTURNA) and angioedema, and rivaroxaban (XARELTO) and thromboembolic events.

The last four years have seen a 90% increase in the number of serious adverse drug event reports received by the Food and Drug Administration (FDA). Investigating the reasons for the four-year trend, we concluded that they could be divided into three groups. Reports for new drugs not widely used in 2008 accounted for 23% of the growth; increasing reports for drugs seen in all four years accounted for 40%. The substantial remainder (37%) was due to special circumstances involving a few suspect drugs that resulted in greatly increased numbers of reports. We examine the reasons for the increase in detail in the full report.

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.