FDA Approved to Remove Black Box Warning on Pfizer’s Chantix

U.S. Food and Drug Administration on 16th December permitted Pfizer to take out a serious warning from the label of its smoking cessation treatment, Chantix, providing a new lease of life to the controversial medicine that was approved several years ago.

The U.S. FDA slapped a “black box” warning – the most serious available – on Chantix in 2009 following getting 1000’s of reports connecting the drug to mental health problems, which includes suicidal feelings, anger and frustration.

Pfizer, which has invested heavily on promotion for and settling lawsuits against Chantix, was unable to remove the warning in 2014 following the FDA made the decision to wait for additional trial data.

Since that time, Pfizer has released data that demonstrated Chantix did not considerably enhance the side-effects. The trial had compared either Chantix or GSK’s Zyban with a placebo or a nicotine patch in sufferers with and without a history of psychiatric problems.

Depending on the data, an independent committee to the FDA in September narrowly voted in favor of getting rid of the warning, disagreeing that the advantages of Chantix outweighed the demerits of its side effects and that there was no clear proof of causality among the drug and the side effects.

However, FDA researchers had disputed the clinical trial data, flagging several variance in data collection. But when they omitted data they considered unreliable, the trial outcomes appeared to be reliable with Pfizer’s conclusion.

Pfizer said on 17th that the FDA agreed to take out the “black box” caution on Chantix, but said the label must consist of the post-marketing reports of the serious side-effects connected with the drug.

The FDA also needed that the label point out that Chantix was more effective than other accessible anti-smoking treatments.

It is very unusual for the FDA to rescind a “black box” caution, and critics have raised worries that such a decision could set a dangerous precedent.