A Pharmaceutical watch dog group has reported that the risks of smoking cessation drug Chantix (Varenicline) have been underestimated in the latest round of the Food & Drug Administration reporting.
The Institute for Safe Medication Practices has recommended that the FDA conduct an investigation after discovering Chantix’s manufacturer, Pfizer, failed to submit 589 reports about serious and fatal adverse events linked to the drug between 2006 and 2010. Exactly 150 of these reports were for completed suicides.
“These additional cases more than doubled the total suicides (linked to Chantix) that were in the AERS system and available to the FDA and others for safety analysis,” according to the nonprofit organization’s report.
Drug manufacturers are required to report “serious adverse drug events” to the FDA AERS monitoring system within 15 days. Other reports take place on a quarterly basis.
Pfizer instead, included the 589 serious and fatal adverse events, with more than 26,000 non-serious adverse events for the 2010 third quarter reporting cycle, according to the Institute.
“To classify a suicide or suicide attempt as an ‘expected adverse event’ rather than submitting it promptly as a 15-day report where it would have been immediately available is troubling in our view,” the report read.
Completed suicides were not the only problems underestimated, according to the Institute’s report. Other problems included attempted suicides, hostility/aggression, depression and possible psychosis.
