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DEXILANT (dexlansoprazole) Product Information Updated Regarding Coadministration with Plavix (clopidogrel bisulfate)
Date:11/17/2011

DEERFIELD, Ill., Nov. 17, 2011 /PRNewswire/ -- Today, Takeda Pharmaceuticals North America, Inc., (Takeda) announced the DEXILANT (dexlansoprazole) product labeling now includes information from a study in healthy subjects demonstrating that DEXILANT had no clinically important effect on exposure to the active metabolite of clopidogrel or clopidogrel-induced platelet inhibition. No dose adjustment of clopidogrel is necessary when administered with an approved dose of DEXILANT. DEXILANT is a proton pump inhibitor (PPI) indicated for the treatment of gastroesophageal reflux disease (GERD). GERD affects nearly 19 million Americans.

Clopidogrel is an antiplatelet drug that is indicated for the reduction of atherothrombotic events in patients with acute coronary syndromes, recent myocardial infarction, recent stroke or established peripheral arterial disease. Studies have suggested that, to varying degrees, PPIs inhibit the enzyme (CYP2C19), which metabolizes clopidogrel to its active form. Since 2009 the U.S. Food and Drug Administration (FDA) has issued multiple communications stating that the concomitant use of clopidogrel and omeprazole be avoided.

"An estimated 25 million prescriptions were dispensed for clopidogrel last year, and given the high prevalence of gastroesophageal reflux disease, it is likely that some of these same patients may also be taking a PPI for their GERD," said David A. Johnson, M.D., FACG, FASGE, professor of Medicine, chief of Gastroenterology, Eastern Virginia School of Medicine, Norfolk, VA. "The study findings are important because as health care providers we have a responsibility to find appropriate treatment regimens for these patients without potentially reducing the intended anti-platelet effects of Plavix."

About the DEXILANT and Clopidogrel Study

Takeda conducted a randomized, open-label, two-period, crossover study to evaluate the effect of DEXILANT on the pharmacokinetics and pharmacodynami
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SOURCE Takeda Pharmaceuticals North America, Inc.
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