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Genetics & Genomics

FDA Recommends Genetic Testing for Coumadin Patients; PGXL Laboratories Cited on ABC 'World News Tonight'

Published in Medical Letter on the CDC and FDA, September 16th, 2007

In a milestone decision on August 17, 2007, the FDA announced important changes in the warfarin label (also known as Coumadin), recommending that a lower initial Coumadin dose "should be considered for patients with certain genetic variations." Coumadin is a commonly prescribed blood thinner with an extremely narrow safe-dosage range varying dramatically from patient to patient.

Patients who take a dose larger than they can tolerate are at risk of life-threatening bleeding events, according to the FDA. Coumadin complications are responsible for about 30,000 emergency room visits a year in the United States. Simple genetics testing done at the beginning of Coumadin...

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