FDA drops boxed warning about serious neuropsychiatric events on Pfizer's Chantix

Pfizer announced Friday that the FDA has approved updates to the labeling of its smoking-cessation therapy Chantix (varenicline), including removal of the boxed warning about serious neuropsychiatric events. The company said the decision, which is in line with a recent FDA advisory panel recommendation that backed removing the warning, was based on outcomes of the post-marketing EAGLES trial involving patients with and without a history of psychiatric disorder.

Pfizer said the updated label notes that post-marketing reports of serious or clinically significant neuropsychiatric adverse events in Chantix-treated patients included changes in mood, psychosis, hallucinations, paranoia, delusions, homicidal ideation, aggression, hostility, agitation, anxiety and panic, as well as suicidal ideation, suicide attempt and completed suicide. The company said the label was also revised to add information on the superior efficacy of Chantix compared to GlaxoSmithKline's anti-smoking drug Zyban (bupropion) or nicotine patch. The FDA noted that the language describing the serious mental health side effects observed in patients taking bupropion products to quit smoking will also be removed from the boxed warning of those products' labels. 

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Freda Lewis-Hall, chief medical officer at Pfizer, said "we are pleased with the FDA's decision to update the Chantix labeling based on EAGLES…and we expect this new information may further facilitate an informed discussion about quitting with Chantix between smokers and healthcare providers." Pfizer generated $426 million in US sales for Chantix last year. 

The FDA in 2009 required that both Pfizer and GlaxoSmithKline add boxed warnings to their respective smoking-cessation products about the risk of "serious mental health events, including changes in behaviour, depressed mood, hostility and suicidal thoughts." Pfizer failed to have the warning removed in 2014 when a majority of FDA advisory panel members voted that the warning should be kept and the agency decided to wait for data from the EAGLES trial. 

Regulators in Europe, where Pfizer markets the therapy under the name Champix, lifted a similar warning on the product's label in May. 

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