Quit-Smoking Drug Chantix Comes Under FDA Scrutiny
Saturday, 26 Apr 2014 09:54 AM
The Food and Drug Administration announced Friday it will hold a public
meeting in October to review the risks of psychiatric and behavioral side effects
with Pfizer's anti-smoking drug
Chantix.
The agency said in a federal
notice it will convene its panel of psychiatric drug experts to discuss the
pill's risks and how to best manage them.
Since 2009 Chantix has carried the
government's strongest safety warning - a "black box" label - because
of links to hostility, agitation, depression and suicidal thoughts. The warning
was added after the FDA received dozens of reports of suicide and hundreds of
reports of suicidal behavior among patients taking the smoking-cessation drug.
At that time, the FDA also
required Pfizer to conduct additional studies to determine the extent of the
side effects.
A spokeswoman for Pfizer said
Friday that the company recently submitted new data to the FDA designed to establish
the drug's safety compared with placebo and other anti-smoking therapies.
"Pfizer has proposed an
update to the Chantix labeling based on these new data, which, we believe,
would better reflect the product's safety profile as it pertains to
neuropsychiatric symptoms," said Victoria Davis, in a statement.
The New York drugmaker's FDA submission includes
data pooled from multiple Pfizer studies along with studies conducted by the U.S. Department of Defense and the Department of Veterans Affairs. The two
federally-funded studies, released in 2011, did not show an increased rate of
psychiatric hospitalizations among more than 26,000 Chantix patients when
compared with patients using nicotine patches and other smoking cessation
treatments. The studies only recorded psychiatric problems that resulted in
hospitalization, meaning many issues likely went unreported, according to the
authors.
Chantix works by binding to the
same spots in the brain that are activated by nicotine when people smoke. The
drug, known chemically as varenicline, blocks nicotine from binding to those
spots and causes the release of a "feel-good" brain chemical called
dopamine.
The FDA first began investigating
potential side effects with Chantix in 2007, the year after the twice-a-day
pill hit the market.
The drug's labeling tells patients
to stop taking Chantix immediately if they experience agitation, depressed
mood, suicidal thinking and other behavioral changes. Doctors are advised to
weigh the drug's risks against its potential benefits in helping patients quit
smoking.
Chantix had global sales of $648
million last year. That was down about 26 percent from the drug's peak sales of
$883 million in 2007, its first full year on the market.
U.S.
Food and Drug Administration (FDA)
Mark B. McClellan
was a commissioner for the U.S. Food and
Drug Administration (FDA), an administrator of Medicare and Medicaid for
the U.S. Department of Health and Human
Services, and a senior fellow at the Brookings
Institution (think tank).
Note: Foundation
to Promote Open Society was a funder for the Brookings Institution
(think tank), and the Committee for
Economic Development.
George Soros
was the chairman for the Foundation to Promote Open Society.
Vernon E. Jordan Jr. is an honorary
trustee at the Brookings Institution (think tank), a senior counsel for Akin, Gump, Strauss, Hauer & Feld, LLP,
Valerie B. Jarrett’s great uncle, a director at the American Friends of Bilderberg
(think tank), and a 2008 Bilderberg conference participant (think tank).
Akin,
Gump, Strauss, Hauer & Feld, LLP is a lobby firm for Pfizer Inc.
Constance J.
Horner is a director at Pfizer Inc.,
and was a guest scholar at the Brookings Institution (think tank).
Suzanne Nora
Johnson is a director at Pfizer Inc.,
and a trustee at the Brookings Institution (think tank).
Amy
W. Schulman is the EVP & general counsel for Pfizer Inc., and a trustee at the Brookings Institution (think tank).
Duberstein
Group, Inc. is a lobby firm for Pfizer
Inc.
Kenneth M.
Duberstein is the chairman & CEO for the Duberstein Group, Inc., a trustee at the Brookings Institution
(think tank), and was a VP for the Committee
for Economic Development.
Donna
S. Morea was a trustee at the Committee
for Economic Development, and the EVP for the CGI Group Inc.
CGI Group Inc.
was the Obamacare contractor that
developed Healthcare.gov web site.
Obamacare
is Barack Obama’s signature policy
initiative.
Barack
Obama’s signature policy initiative is Obamacare,
and was an intern at Sidley Austin LLP.
Newton
N. Minow is a senior counsel at Sidley
Austin LLP, and a member of the Commercial
Club of Chicago.
Cyrus F.
Freidheim Jr. is an honorary trustee at the Brookings Institution (think tank), and a member of the Commercial Club of Chicago.
Valerie B. Jarrett
is Vernon E. Jordan Jr’s great niece, the senior
adviser for the Barack Obama
administration, and a member of the Commercial
Club of Chicago.
R.
Eden Martin is the president of the Commercial
Club of Chicago, and counsel at Sidley
Austin LLP
Sidley Austin
LLP was a lobby firm for Pfizer Inc.
Frederick W.
Telling was a VP at Pfizer Inc.,
and is a trustee at the Committee for
Economic Development.
Stephen W. Sanger
is a trustee at the Committee for
Economic Development, and a director at Pfizer Inc.
Anthony J. Principi
was the SVP for Pfizer Inc., and the
secretary for the U.S. Department of
Veterans Affairs.
Eric
K. Shinseki is the secretary at the U.S.
Department of Veterans Affairs for the Barack
Obama administration, and was a director at the Atlantic Council of the United
States (think tank).
Togo
D. West Jr. was the secretary at the U.S.
Department of Veterans Affairs, a general
counsel for the U.S. Department of
Defense, and is a director at the Atlantic
Council of the United States
(think tank).
Open
Society Foundations was a funder for the Atlantic Council of the United
States (think tank).
George
Soros is the founder & chairman for the Open Society Foundations, and was the chairman for the Foundation to Promote Open Society.
Foundation
to Promote Open Society was a funder for the Brookings Institution
(think tank).
Chuck
Hagel was the chairman for the Atlantic
Council of the United States
(think tank), the deputy administrator for the U.S. Veterans Administration, and is the secretary for the U.S. Department of Defense for the Barack Obama administration.
Mark B. McClellan
was a senior fellow at the Brookings
Institution (think tank), an administrator of Medicare and Medicaid for the
U.S. Department of Health and Human
Services, and a commissioner for the U.S.
Food and Drug Administration (FDA).
Constance J.
Horner was a guest scholar at the Brookings Institution (think tank),
and is a director at Pfizer Inc.
Suzanne Nora
Johnson is a trustee at the Brookings Institution (think tank), and a
director at Pfizer Inc.
Amy
W. Schulman is a trustee at the Brookings Institution (think tank),
and the EVP & general counsel for Pfizer
Inc.
Robert
A. Helman was an honorary trustee at the Brookings Institution (think tank),
is a member of the Commercial Club of
Chicago, and a partner at Mayer
Brown.
Cyrus F.
Freidheim Jr. is an honorary trustee at the Brookings Institution (think tank), and a member of the Commercial Club of Chicago.
William
M. Daley is a member of the Commercial
Club of Chicago, was the chief of staff for the Barack Obama administration, and a partner at Mayer Brown.
William M. Daley
Professional career
Daley returned to the practice of law, as a partner with the
firm Mayer Brown (then Mayer, Brown & Platt) from 1993 to 1997.
Mayer
Brown was a lobby firm for Pfizer
Inc.
Sidley Austin
LLP was a lobby firm for Pfizer Inc.
Newton
N. Minow is a senior counsel at Sidley
Austin LLP, and a member of the Commercial
Club of Chicago.
R.
Eden Martin is the president of the Commercial
Club of Chicago, and counsel at Sidley
Austin LLP
Michelle
Obama was a lawyer at Sidley Austin
LLP.
Barack
Obama was an intern at Sidley Austin
LLP.
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