FDA
panel recommends dropping serious warning on Pfizer's
Chantix
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[September 15, 2016]
By Natalie Grover
(Reuters) - A serious warning on Pfizer
Inc's quit smoking drug should be removed, 10 of 19 independent
panelists to the U.S. Food and Drug Administration recommended on
Wednesday, after reviewing additional trial data on the controversial
treatment.
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Pfizer's Chantix was approved about a decade ago, but thousands of
reports of mental health problems in users led to the FDA imposing
the "black box" warning - the most severe available - in 2009.
On Wednesday, four of the 19 panelists voted to update the language
in the box warning - of neuropsychiatric risks including suicidal
thoughts, hostility and agitation - while five recommended retaining
it.
The 10 who voted in favor of removal stressed that the benefits of
quitting smoking far outweighed the potential severe side-effects of
the drug, and that the evidence of causality between Chantix and the
side-effects was not clear enough to warrant a black box.
Cigarette smoking is the leading cause of preventable disease and
death in the United States, accounting for about 1 of every 5
deaths, according to the U.S Centers for Disease Control and
Prevention.
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Pfizer failed a previous attempt to get rid of the boxed warning,
after the FDA went along with a panel recommendation in 2014 to
retain it pending the outcome of the additional study.
Since then Pfizer has released results from the study that compared
either Chantix or GlaxoSmithKline Plc's <GSK.L> Zyban, with a
placebo or a nicotine patch in patients with and without a history
of psychiatric disorders.
FDA staff on Monday issued a scathing review of how the study was
conducted by Pfizer, flagging multiple inconsistencies across the
140 sites and multiple countries in which data was collected.
But when the FDA conducted its own analysis, excluding data they
deemed unreliable, the results appeared to be consistent with
Pfizer's conclusion that Chantix does not significantly increase the
incidence of such side-effects.
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The discussion among panelists on Wednesday ranged from whether
certain adverse events were the result of tobacco withdrawal or the
drug, as well as the trend of a higher number of psychiatric
side-effects seen in patients with a history of mental illness.
Patients with psychiatric disorders are far more vulnerable to
tobacco addiction, and less likely to be prescribed treatments for
smoking cessation, they noted, saying that the exclusion of the
boxed warning would go a long way in improving statistics.
Some panelists who voted to modify the warning or retain it in its
present form, said they were fearful of setting a dangerous
precedent for other drugmakers looking to remove such warnings off
of their products, or that Pfizer's implementation of trial design
left a lot to be desired.
The FDA is not obligated to follow the recommendations of its panel,
but typically does so.
(Reporting by Natalie Grover in Bengaluru; Editing by Don Sebastian
and Andrew Hay)
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