FDA drops stringent warnings on Pfizer’s Chantix anti-smoking treatment

crew-2231211It’s a serious shame that the FDA used anecdotal, i.e. non-scientific data to put a black box warning on the package insert for physicians describing alleged serious psychological side effects including suicide in those taking the medication.

 

Actual scientific evidence using prospective studies show there was no such validity to the claims.

When a black box warning is put in the labeling, it all but kill a drug as physicians greatly curtail their prescriptions.

The number of individuals who would have quit smoking with the help of Chantix, is, of course, unknown.

E-Cigarettes spark fire on American Airlines flight. (Source)

Wall Street Journal

By Jonathan D. Rockoff

December 16, 2016

 

 

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

 

chantix-black-box

 

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.

 

Is it really the FDA’s job to spend taxpayers money targeting kids to get them to quit smoking?

 

 

“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.

See the entire article below.

 

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 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 worldwide sales last year.

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

THE END

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About JCscuba

I am firmly devoted to bringing you the truth and the stories that the mainstream media ignores. Together we can restore our constitutional republic to what the founding fathers envisioned and fight back against the progressive movement. Obama nearly destroyed our country economically, militarily coupled with his racism he set us further on the march to becoming a Socialist State. Now it's up to President Trump to restore America to prominence. Republicans who refuse to go along with most of his agenda RINOs must be forced to walk the plank, they are RINOs and little else.
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