Pfizer Chantix Not Linked To Suicide and Other Psychiatric Effects

Almost seven years since US health authorities slapped a black box warning on Chantix, pharmaceutical giant Pfizer is in a celebratory mood after an international study found no conclusive evidence or whatsoever that would effectively link the anti-smoking cessation drug to severe risk of suicide and other psychiatric side-effects.

The study was originally commissioned by the Food and Drug Administration to verify disturbing claims of neuropsychiatric side effects tied to the Pfizer's Chantix and GlaxoSmithKline's Zyban, two of the world's leading anti-smoking branded drugs. Both drugs contained Black Box labeling or safety alerts following the previously filed reports.

"The findings show that it is highly unlikely that (the medicines) contribute to neuropsychiatric adverse events," the authors of the study concluded even providing 'first definitive evidence' that the highly controversial pills have actually helped people with psychiatric problems to kick smoking off their habit as per Stat News report.

The study, codenamed EAGLES, involved a series of randomized controlled trials overseen by an international group of experts involving 8,144 smokers in 16 countries. Patients were observed as they used a placebo, a nicotine patch, Chantix or Zyban for 12 weeks and then subjected to another 12 weeks of follow-up observation. The subjects were also divided into two: those with preexisting psychiatric disorders and those without any known psychiatric conditions.

The results of the trials revealed that 1.3% of people without psychiatric problems who took Chantix reportedly experienced moderate to severe side effects which was comparatively lower than 2.2% Zyban users, 2.5% of nicotine patch users, and 2.4% in patients taking placebo.

As for rates of neuropsychiatric side effects, 6.5% Chantix patients reportedly had moderate to severe side effects which was slight lower to Zyban users' 6.7%. Nicotine patch and placebo users had 2.5% and 2.4% moderate to severe side effects respectively.

Interestingly, Chantix appeared to have emerged as the winner in terms of aiding patients to get rid of undesirable smoking habit compared to Zyban, nicotine patch, or placebo.

"This is the largest randomized, controlled trial to date comparing these smoking-cessation medications directly and comparing them with placebo," remarked lead author Robert Anthenelli, professor of psychiatry at the UC San Diego School of Medicine and lead author of the study as quoted by FiercePharma.

"We are hoping that the recognition that these medications are safe for smokers with and without psychiatric disorders will encourage people to try and quit, and feel comfortable that they can use any of the available medications."

Since anti-smoking cessation pills like Chantix or Zyban have been tagged as safe by the recent FDA-commissioned study, drug manufacturers, especially Pfizer, are hoping to finally get a green light from US-based authorities before their patents expire.

"The FDA will review the findings of this study along with additional scientific evidence as we continue to evaluate this issue, as well as take follow-up action and update the public as appropriate," the regulatory body said in an official statement as quoted by The Olympian.