FDA c'tee backs DNA test for Coumadin Rxing

An advisory committee to the US Food and Drug Administration has recommended genotyping patients at the beginning of Coumadin (warfarin) therapy to allow them to be more quickly stabilized at safe and effective dosage levels. The FDA committee points out that genotyping by DNA testing can help to reduce potentially fatal and serious adverse reactions to the drug.

Historically, achieving the correct dose of warfarin was a matter of "trial and error" often requiring many months; leaving patients vulnerable to deadly bleeding reactions or recurrent stroke, thromboembolism, or other adverse clotting events.

According to the FDA, hemorrhage during warfarin therapy is a one of the country's leading causes of death due to a prescribed drug and adverse issues related to warfarin therapy are the cause of one in 10 hospital admissions. The new tests, offered by Genelex Corp, allow physicians to more accurately determine the correct warfarin dose. "This is a perfect example of the new movement towards personalized medicine, based on the individual's DNA, rather than prescription by trial and error. The age of 'one dose fits all' is ending," said Genelex chief executive Howard Coleman.