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FDA Approves New 300mg Loading Dose Tablet for PLAVIX(R) (clopidogrel bisulfate)
Date:9/27/2007

ith ST-segment elevation acute myocardial infarction, 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. This benefit is not known to pertain to patients who receive primary angioplasty.

Important Risk Information

-- PLAVIX is contraindicated in patients with active pathologic bleeding

such as peptic ulcer or intracranial hemorrhage. PLAVIX should be used

with caution in patients who may be at risk of increased bleeding from

trauma, surgery, or coadministration with NSAIDs or warfarin. (See

CONTRAINDICATIONS and PRECAUTIONS.*)

-- The rates of major and minor bleeding were higher in patients treated

with PLAVIX plus aspirin compared with placebo plus aspirin in clinical

trials. (See ADVERSE REACTIONS.*)

-- As part of the worldwide post marketing experience with PLAVIX, there

have been cases of reported thrombotic thrombocytopenic purpura (TTP),

some with fatal outcome. TTP has been reported rarely following use of

PLAVIX, sometimes after a short exposure (<2 weeks). TTP is a serious

condition that can be fatal and requires urgent treatment including

plasmapheresis (plasma exchange). (See WARNINGS.*)

-- In clinical trials, the most common clinically important side effects

were pruritus, purpura, diarrhea, and rash; infrequent events included

intracranial hemorrhage (0.4%) and severe neutropenia (0.05%). (See

ADVERSE REACTIONS.*)

*Please see full prescribing information by visiting http://www.plavix.com.

About sanofi-aventis

Sanofi-aventis is one of the world leaders in the pharmaceutical industry, ranking number one in Europe. Backed by a world-class R&D organization, sanofi-aventis is developing leading positions in seven major therapeutic areas: cardiova
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SOURCE Bristol-Myers Squibb Company
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