Published: March 12, 2010
Sanofi-aventis and Bristol-Myers Squibb Announce Important Updates to PLAVIX U.S. Prescribing Information
BRIDGEWATER, N.J. & PRINCETON, N.J. - (BUSINESS WIRE) - Sanofi-aventis
U.S. and Bristol-Myers
Squibb Company (NYSE: BMY) today announced revisions to the U.S.
prescribing information for PLAVIX
(clopidogrel bisulfate), which include a boxed warning. The boxed
warning concerns the diminished effectiveness of PLAVIX in patients who
have a genetic variation leading to reduced formation of the active
metabolite. These patients, who are designated as poor metabolizers,
represent, according to the prescribing information, approximately 2% of
whites, 4% of blacks, and 14% of Chinese. The percentage of poor
metabolizers is estimated to be approximately 3% of the population,
based on published studies.
Patients should continue taking PLAVIX unless told to do otherwise by
their healthcare professional. They should talk with their healthcare
professional if they have any concerns about PLAVIX.
Today, the U.S. Food and Drug Administration (FDA) issued a press
release on this update, which is included below:
FDA Announces New Boxed Warning on Plavix
The U.S. Food and Drug Administration today added a boxed warning to
the anti-blood clotting drug Plavix (clopidogrel), alerting patients and
health care professionals that the drug can be less effective in people
who cannot metabolize the drug to convert it to its active form.
Plavix reduces the risk of heart attack, unstable angina, stroke, and
cardiovascular death in patients with cardiovascular disease by making
platelets less likely to form blood clots. Plavix does not have its
anti-platelet effects until it is metabolized into its active form by
the liver enzyme, CYP2C19.
People who have reduced functioning of their CYP2C19 liver enzyme
cannot effectively convert Plavix to its active form. As a result,
Plavix may be less effective in altering platelet activity in those
people. These "poor metabolizers" may not receive the full benefit of
Plavix treatment and may remain at risk for heart attack, stroke, and
cardiovascular death.
"We want to highlight this warning to make sure health care
professionals use the best information possible to treat their
patients," said Mary Ross Southworth, Pharm.D., a clinical analyst in
the Division of Cardiovascular and Renal Products in the FDA's Center
for Drug Evaluation and Research.
In May 2009, the FDA added this warning to the drug's label. After
reviewing more data, the agency felt it was important to highlight this
risk in a boxed warning.
It is estimated that 2 percent to 14 percent of the U.S. population
are poor metabolizers. The FDA recommends that health care professionals
consider alternative dosing of Plavix for these patients, or consider
using other anti-platelet medications. Tests are available to assess
CYP2C19 genotype to determine if a patient is a poor metabolizer.
Patients should not stop taking Plavix unless told to do so by their
health care professional. They should talk with their health care
professional if they have any concerns about Plavix.
Plavix is made under a Bristol-Myers Squibb - Sanofi Pharmaceuticals
partnership.
These revisions to the prescribing information for PLAVIX reflect
the companies' ongoing research in collaboration with the FDA, which
better defines the patient population that may be affected by a genetic
variation in CYP2C19 and alternate treatment strategies.
IMPORTANT SAFETY INFORMATION
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WARNING: DIMINISHED EFFECTIVENESS IN POOR METABOLIZERS
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The effectiveness of Plavix is dependent on its activation to
an active metabolite by the cytochrome P450 (CYP) system,
principally CYP2C19 [see Warnings and Precautions (5.1)].
Plavix at recommended doses forms less of that metabolite and
has a smaller effect on platelet function in patients who are
CYP2C19 poor metabolizers. Poor metabolizers with acute
coronary syndrome or undergoing percutaneous coronary intervention
treated with Plavix at recommended doses exhibit higher
cardiovascular event rates than do patients with normal CYP2C19
function. Tests are available to identify a patient's
CYP2C19 genotype; these tests can be used as an aid in determining
therapeutic strategy [see Clinical Pharmacology (12.5)].
Consider alternative treatment or treatment strategies in
patients identified as CYP2C19 poor metabolizers [see Dosage
and Administration (2.3)].
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CONTRAINDICATIONS
Plavix is contraindicated in patients with active pathological bleeding
such as peptic ulcer or intracranial hemorrhage.
Plavix is contraindicated in patients with hypersensitivity (e.g.,
anaphylaxis) to clopidogrel or any component of the product.
WARNINGS AND PRECAUTIONS
Avoid concomitant use of Plavix and drugs that inhibit CYP2C19 activity.
Co-administration of Plavix with omeprazole, a proton pump inhibitor
that is an inhibitor of CYP2C19, reduces the pharmacological activity of
Plavix if given concomitantly or if given 12 hours apart [see
Drug Interactions (7.1)].
Thienopyridines, including Plavix, increase the risk of bleeding. If a
patient is to undergo surgery and an antiplatelet effect is not desired,
discontinue Plavix 5 days prior to surgery.
Avoid lapses in therapy, and if Plavix must be temporarily discontinued,
restart as soon as possible. Premature discontinuation of Plavix may
increase the risk of cardiovascular events.
In patients with recent TIA or stroke who are at high risk for recurrent
ischemic events, the combination of aspirin and Plavix has not been
shown to be more effective than Plavix alone, but the combination has
been shown to increase major bleeding.
TTP, sometimes fatal, has been reported following use of Plavix,
sometimes after a short exposure (<2 weeks). TTP is a serious condition
that requires urgent treatment including plasmapheresis (plasma
exchange).
ADVERSE REACTIONS
Bleeding, including life-threatening and fatal bleeding, is the most
commonly reported adverse reaction.
DRUG INTERACTIONS
Coadministering warfarin with Plavix increases the risk of bleeding.
Coadministration of Plavix and NSAIDs increases the risk of
gastrointestinal bleeding.
USE IN SPECIFIC POPULATIONS
Nursing mothers: Discontinue drug or nursing, taking into consideration
importance of drug to mother.
INDICATIONS
Acute Coronary Syndrome (ACS)
For patients with non-ST-segment elevation ACS [unstable angina
(UA)/non-ST-elevation myocardial infarction (NSTEMI)], including
patients who are to be managed medically and those who are to be managed
with coronary revascularization, Plavix has been shown to decrease the
rate of a combined endpoint of cardiovascular death, myocardial
infarction (MI), or stroke as well as the rate of a combined endpoint of
cardiovascular death, MI, stroke, or refractory ischemia.
For patients with ST-elevation myocardial infarction (STEMI), Plavix has
been shown to reduce the rate of death from any cause and the rate of a
combined endpoint of death, re-infarction, or stroke. The benefit for
patients who undergo primary percutaneous coronary intervention is
unknown.
The optimal duration of Plavix therapy in ACS is unknown.
Recent MI, Recent Stroke, or Established Peripheral Arterial Disease
For patients with a history of recent myocardial infarction (MI), recent
stroke, or established peripheral arterial disease, Plavix has been
shown to reduce the rate of a combined endpoint of new ischemic stroke
(fatal or not), new MI (fatal or not), and other vascular death.
Please see full prescribing information, including BOXED WARNING for
the United States by visiting www.PLAVIX.com.
About sanofi-aventis
Sanofi-aventis U.S. is an affiliate of sanofi-aventis, a leading global
pharmaceutical company that discovers, develops and distributes
therapeutic solutions to help improve the lives of patients.
Sanofi-aventis is listed in Paris (EURONEXT: SAN) and in New York
(NYSE:SNY) . For more information, www.sanofi-aventis.us
or www.sanofi-aventis.com.
About Bristol-Myers Squibb
Bristol-Myers Squibb is a global biopharmaceutical company whose mission
is to discover, develop and deliver innovative medicines that help
patients prevail over serious diseases. For more information, please
visit www.bms.com.
Sanofi-aventis Forward-Looking Statement
This press release contains forward-looking statements as defined in the
Private Securities Litigation Reform Act of 1995, as amended.
Forward-looking statements are statements that are not historical facts.
These statements include projections and estimates and their underlying
assumptions, statements regarding plans, objectives, intentions and
expectations with respect to future financial results, events,
operations, services, product development and potential and statements
regarding future performance. Forward-looking statements are generally
identified by the words "expects," "anticipates," "believes," "intends,"
"estimates," "plans" and similar expressions. Although sanofi-aventis'
management believes that the expectations reflected in such
forward-looking statements are reasonable, investors are cautioned that
forward-looking information and statements are subject to various risks
and uncertainties, many of which are difficult to predict and generally
beyond the control of sanofi-aventis, that could cause actual results
and developments to differ materially from those expressed in, or
implied or projected by, the forward-looking information and statements.
These risks and uncertainties include among other things, the
uncertainties inherent in research and development, future clinical data
and analysis, including post marketing, decisions by regulatory
authorities, such as the FDA or the EMA, regarding whether and when to
approve any drug, device or biological application that may be filed for
any such product candidates as well as their decisions regarding
labelling and other matters that could affect the availability or
commercial potential of such products candidates, the absence of
guarantee that the products candidates if approved will be commercially
successful, the future approval and commercial success of therapeutic
alternatives, the Group's ability to benefit from external growth
opportunities as well as those discussed or identified in the public
filings with the SEC and the AMF made by sanofi-aventis, including those
listed under "Risk Factors" and "Cautionary Statement Regarding
Forward-Looking Statements" in sanofi-aventis' annual report on Form
20-F for the year ended December 31, 2008. Other than as required by
applicable law, sanofi-aventis does not undertake any obligation to
update or revise any forward-looking information or statements.
Bristol-Myers Squibb Forward-looking Statement
This press release contains "forward-looking statements" as that term is
defined in the Private Securities Litigation Reform Act of 1995,
regarding the research, development and commercialization of
pharmaceutical products. Such forward-looking statements are based on
current expectations and involve inherent risks and uncertainties,
including factors that could delay, divert or change any of them, and
could cause actual outcomes and results to differ materially from
current expectations. No forward-looking statement can be guaranteed.
Forward-looking statements in the press release should be evaluated
together with the many uncertainties that affect Bristol-Myers Squibb's
business, particularly those identified in the cautionary factors
discussion in Bristol-Myers Squibb's Annual Report on Form 10-K for the
year ended December 31, 2009, its Quarterly Reports on Form 10-Q, and
Current Reports on Form 8-K. Bristol-Myers Squibb undertakes no
obligation to publicly update any forward-looking statement, whether as
a result of new information, future events, or otherwise.
Media:
sanofi-aventis
Elizabeth
Baxter, 908-981-5360
elizabeth.baxter@sanofi-aventis.com
or
Bristol-Myers
Squibb
Laura Hortas, 609-252-4587
laura.hortas@bms.com
or
Investors
Felix
Lauscher, 908-981-5560
ir@sanofi-aventis.com
or
John
Elicker, 609-252-4611
john.elicker@bms.com
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