The drug regulators in the US suspect Pfizer’s smoking cessation drug Chantix (varenicline), to be the cause of serious psychiatric problems. The FDA reportedly received 491 reports of suicidal behaviour and thinking (420 in the US) and 39 actual suicides, 34 of which took place in US. FDA has also said that its evaluation of the post-marketing adverse event reports on Chantix (varenicline) indicated a greater degree of possibility of association between the drug and serious neuropsychiatric symptoms exhibited by the patients.
Bob Rappaport, director of the FDA’s division of Anaesthesia, Analgesia and Rheumatology Products, said: “Chantix has proven to be effective in smokers motivated to quit. But it is important to consider these safety concerns and alert the public about these risks.”