QuarterWatch® Reports

Serious Adverse Drug Event Reports Increase 25% in 2008

Serious, disabling and fatal adverse events reported to the FDA increased by 25% for the full year of 2008, the largest increase since the beginning of our historical data in 1998. The biggest identifiable safety factor in the increase was reports associated with the massive recalls of generic drugs that occurred throughout the year. We also found that approximately half the increase occurred because of more voluntary reporting to the FDA, and from certain manufacturers.

While the FDA added important new black box warning for varenicline (CHANTIX) and psychiatric side effects, a better and clearer warning about accident risk is needed. Given the association of varenicline with aggressive, violent and hostile behavior we recommend that the ban on varenicline be extended from pilots and missile crews to all active duty military personal, police and emergency workers.


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.