It is a known fact that in 2009 US FDA kept black box warning for Pfizer’s stop smoking drug Chantix. FDA cautioned that the drug could be associated to severe psychiatric side effects. From that time Pfizer has been lobbying the FDA to back off of the warning, and now they might feel happy as a global study provides results which could work in its favor.
According to results presented in The Lancet recently, study of Chantix and GSK’s Zyban identified that the medicines do not raise individuals’ risks of neuropsychiatric side effects. The medicines also overcome a nicotine patch and placebo at supporting individuals to quit smoking.
The randomized controlled study, known as EAGLES, involved 8,144 smokers in 16 nations. For 12 weeks, individuals used either a placebo, a nicotine patch, Chantix or Zyban, and then had 12 weeks of follow up. The active component in Zyban is also available as an anti-depressant under the brand Wellbutrin.
Smokers were also split into two groups: those without having psychiatric problems and those with pre-existing psychiatric problems. Investigators identified that 1.3 percent of individuals without psychiatric disorders who were getting Chantix had moderate to serious side effects. That compares to 2.2 percent of Zyban users, 2.5 percent of nicotine patch users and 2.4 percent in the placebo group.
Smokers with psychiatric problems had a little bit higher rates of neuropsychiatric side effects. Around 6.5 percent of individuals taking Chantix had moderate to serious side effects, in comparison with 6.7 percent for Zyban, 2.5 percent for the nicotine patch and 2.4 percent for placebo.
The international study found, Chantix the champion when it came to supporting smokers who wish to avoid smoking. More smokers taking the medicine abstained than those who used Zyban, the patch or a placebo. Zyban as well as a patch also aided more sufferers abstain than a placebo did.
Lead author of the study Robert Anthenelli said
“This is the biggest randomized controlled study to date evaluating these smoking quitting drugs directly and evaluating them with placebo.”
“We are expecting that the recognition that these drugs are safe for smokers with and without psychiatric problems will encourage individuals to try and quit, and feel comfortable that they can use any of the accessible drugs.”
Pfizer is expecting that the outcomes get the FDA to switch its decision regarding Chantix’s safety and back off of the block box warning.