ISMP’s report states that Chantix, a drug prescribed to help people stop smoking, "accounted for more reported serious injuries than any other prescription drug for a second quarter...." Heparin, which was subjected to a recall resulting from product contamination, had the second highest number of serious injury reports.

ISMP notes that the result of the FDA’s monitoring program "should be interpreted with caution because of the known limitations of these data, and the nature of the overall system...." Moreover, ISMP stressed that "Many reports to the FDA were vague and would be difficult to analyze in depth. We found that 15% of all serious reports lacked two or more elements of basic information..." and "We also detected a significant technical error in how reports were being coded by the FDA or drug manufacturers."

Chantix’s manufacturer stated that "Based on that totality of data, we stand by the efficacy and safety profile of Chantix when used as directed...." The company also explained that the injury reports "are often unverifiable and lack sufficient medical information to draw any conclusions."

The FDA reporting system, were it accurate and objective, could be useful to regulatory officials. As the situation currently stands, however, the deeply flawed FDA reporting system is most useful for highlighting the need for quality controls on all data agencies disseminate to the public.

See WSJ story

See Institute for Safe Medication Practices report