FDA Labeling Supports DNA Testing For Patients Prescribed Warfarin

Armen Hareyan's picture
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Prescribed Warfarin

FDA has announced important changes in the warfarin label, recommending that a lower initial warfarin dose should be considered for patients with certain genetic variations.

Warfarin (Coumadin) is a commonly prescribed blood thinner with an exceptionally narrow safe-dosage range that varies dramatically from patient to patient.

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Historically, determining the correct dose often took multiple clinical visits and blood tests over several weeks or months. Until the correct dosing was established, patients were vulnerable to potentially deadly clotting events such as stroke, and side effects such as hemorrhages, excessive bruising or internal bleeding.

Simple genetics testing done at the beginning of warfarin 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.

The AEI-Brookings Joint Center estimates that formally integrating genetic testing into routine warfarin therapy could allow American warfarin users to avoid 85,000 serious bleeding events and 17,000 strokes annually, reducing costs by an estimated $1.1 billion annually.

Howard Coleman, Founder and CEO of Seattle's Genelex Corporation, is enthusiastic about the FDA's new labeling. "This is a perfect example of the movement towards personalized medicine, medicine that is prescribed based on the patient's own DNA. The age of trial-and-error prescribing is ending -- as it should".

Coleman continued, "Genetic testing at the initiation of warfarin therapy will save money and lives. Warfarin DNA testing is the most obvious example of how genetic technology can be applied to improve patient care."

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