GSK GSK plc

By Jonathan D. Rockoff 

Pfizer Inc. said Friday that the Food and Drug Administration will no longer require the company's smoking-cessation pill Chantix carry a stringent warning about a potential link to suicide, depression and hostile behavior, years after fears of such links torpedoed use.

The label for Chantix can also say the pill works better than the nicotine patch and another smoking-cessation pill known generically as bupropion, Pfizer said.

The changes keep the standard precautions in the body of the Chantix label warning doctors and patients to be on the lookout for psychiatric side effects. Yet the action suggests health authorities have abandoned the most serious fears about the pill's safety that triggered a so-called "black box" warning. A boxed notice on a drug's label denotes the most severe risks.

"We expect this new information may further facilitate an informed discussion about quitting with Chantix between smokers and" doctors, Pfizer Chief Medical Officer Freda Lewis-Hall said in a statement.

GlaxoSmithKline PLC sells bupropion under the brand name Zyban. The company didn't immediately respond to a request for comment.

Europe's main drug regulator took a similar action early this year to remove the serious warnings from Chantix's label.

Approved in 2006, Chantix was hailed by public-health officials for its potential to help curb smoking addiction. The drug was on its way to becoming a billion-dollar seller for Pfizer when the safety concerns surfaced. Anecdotal reports of the risks mounted in late 2007, and eventually prompted the FDA to require the black box warning on Chantix's label in 2009.

The warning throttled sales. Chantix was prescribed just 2.2 million times in the U.S. last year, down from a peak of 7.3 million in 2007, according to QuintilesIMS.

Pfizer has long argued there was no evidence to support the link between Chantix use and a higher rate of psychiatric side effects. In 2014, the company asked the FDA to remove the stringent warning based on an analysis of drug studies.

The FDA held off on a decision until results from an 8,144-subject study probing the safety of Chantix and bupropion, sponsored by Pfizer and GlaxoSmithKline, were published in The Lancet medical journal earlier this year. The study found Chantix and bupropion subjects didn't have significantly higher rates of psychiatric side effects than smokers on the nicotine patch or taking a placebo.

The removal of the warning could help boost Chantix sales, just as Pfizer seeks new sources of revenue to offset expected losses from looming generic competition for blockbusters like the male-impotence pill Viagra.

Pfizer reported Chantix had $198 million in world-wide sales last year.

Write to Jonathan D. Rockoff at Jonathan.Rockoff@wsj.com

(END) Dow Jones Newswires

December 16, 2016 15:08 ET (20:08 GMT)

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