ISMP Safe Medicine November/December 2008, Volume 6, Number 6. ©2008 ISMP

Brand name medicines appear in green; generic medicines appear in red.

New QuarterWatchT program warns of Chantix, acetaminophen, and ibuprofen risks

The publisher of Safe Medicine, the Institute for Safe Medication Practices (ISMP), began a new program this year called QuarterWatch. This program allows us to look at medication errors and serious side effects reported to the US Food and Drug Administration (FDA). Using these reports we identify safety problems with specific medicines. We report these safety problems to FDA and the companies that make the medicines. We let your doctors, nurses, and pharmacists know about these safety problems. We also get the word out to the public through news reports in newspapers, newsletters, and on television.

In our first QuarterWatch report (www.ismp.org/docs/vareniclineStudy.asp) we revealed that the prescription drug Chantix (varenicline) had the most reported safety concerns in October-December 2007.

Many of the safety problems reported were not previously linked to Chantix. Our QuarterWatch findings led the government to ban the use of Chantix by airline pilots and military missile crews.

In our second report (www.ismp.org/quarterwatch/2008Q1.pdf), Chantix continues to have the highest number of serious reported side effects. Between January and March 2008 there were 1,001 new reports of injuries with Chantix, including 50 deaths.  

The reports submitted to FDA that we use for the QuarterWatch program are all voluntary. They represent only the problems healthcare providers or con-sumers have decided to report to FDA. And the reports themselves are not investigated to prove that the suspected medicine caused the bad outcome. While the QuarterWatch results should therefore be interpreted with caution, this new source of information is much needed to help use medicines safely.