FDA takes down highest warnings from Pfizer’s and GSK’s quitting smoking drugs

The U.S. Food and Drug Administration (FDA) has found that the mental-health side effect risk of Pfizer’s and GSK’s quitting smoking drugs Chantix and Zyban respectively is lower than previously thought. 

Therefore, it will remove the Boxed Warning – its most prominent warning – for serious mental health side effects from the Chantix drug label, and from the Boxed Warning in the Zyban label, the FDA said on Friday.

Stopping smoking outweigh the risks of these medicines

FDA required Pfizer and GlaxoSmithKline to evaluate the mental safety of Chantix and Zyban for smoking cessation in patients without and with a history of psychiatric disorders.

After a review of the trial, it found that the  risk of these mental health side effects is still present. However, the FDA said that  most people who had these side effects did not have serious consequences such as hospitalization. The results of the trial confirm that the benefits of stopping smoking outweigh the risks of these medicines, the FDA said.

Chantix works by blocking the effects of nicotine from smoking on the brain, and Zyban works by altering the level of some chemicals in the brain, which may relieve the withdrawal symptoms that occur when stopping smoking.