FDA Drops Stringent Warning on Smoking-Cessation Drug Chantix
17 December 2016 - 7:23AM
Dow Jones News
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)
Copyright (c) 2016 Dow Jones & Company, Inc.
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