FDA Recommends Genetic Testing For Coumadin Patients

Armen Hareyan's picture
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Coumadin Patients

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."

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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 therapy can help reduce serious adverse reactions to the drug, by quickly determining safe and effective dosing levels based on the patient's unique genetic makeup.

PGXL Laboratories in Louisville, Kentucky, was the first CLIA-approved laboratory in the U.S. to offer diagnostic testing for Coumadin patients. In fact, PGXL Laboratories was one of two laboratories recommended on "ABC World News Tonight" on August 17, 2007.

"We have a vital national role to play at PGXL Laboratories," said Dr. Roland Valdes, PGXL President and Senior Vice Chairman of the Department of Pathology and Laboratory Medicine at the University of Louisville. "Our laboratory is in the unique position of offering Coumadin testing on a routine basis. We also offer a three-day turnaround -- which is ideal for initial Coumadin dosing analysis."

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