FDA removes black box warning on Pfizer’s anti-smoking medication

pharmafile | December 19, 2016 | News story | Medical Communications, Sales and Marketing GlaxoSmithKline, Pfizer, anti-smoking, nicotine, smoking 

The FDA has decided to remove the “black box” warning upon Pfizer’s anti-smoking drug, Chantix, basing its decision upon the completion of a clinical trial looking into the side-effects of the drug. The EAGLES clinical trial, conducted alongside GlaxoSmithKline, studied 8,144 individuals and found that the patients did not have significantly higher rates of psychiatric side-effects compared with those using a nicotine patch or on the placebo.

Chantix was originally approved in 2006 to help smokers who wanted to quit. The drug works by binding to the same area of the brain that is activated by nicotine when people smoke. This effectively blocks nicotine binding to the same area and therefore denies a major part of a smoker’s desire to smoke, the ease in nicotine craving.

The drug was anticipated to be a blockbuster seller for Pfizer but safety issues were raised when reports of mental health issues were raised by patients taking the drug. The FDA reacted, in 2009, by requiring a black box warning on Chantix’s label that states the most serious side-effects of the drug.

The result was that sales of the drug declined, from a high of 7.3 million in 2007 to just 2.2 million in sales last year. Pfizer and GSK, who own the rights to Zyban – a drug of similar action, will be hoping that the reversal of the decision to include strong warnings upon the label will positively influence sales and the public and medical perception of the drug.

“For millions who smoke, stopping smoking is one of the most important steps they can take to improve their health, and Pfizer is committed to helping smokers in their quit journey,” said Freda Lewis-Hall, chief medical officer and executive vice president at Pfizer. “We are pleased with the FDA’s decision to update the Chantix labelling based on EAGLES – the largest clinical trial of smoking cessation medications – and we expect this new information may further facilitate an informed discussion about quitting with Chantix between smokers and healthcare providers.”

Ben Hargreaves

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