FDA Committee Supports Simple DNA Tests When Patients Are Prescribed Coumadin (Warfarin)
Posted on: Monday, 20 November 2006, 12:01 CST
SEATTLE, Nov. 20 /PRNewswire/ -- A blue-ribbon advisory committee to the FDA has recommended genotyping patients at the beginning of Coumadin (generic name warfarin) therapy to allow patients 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 ten hospital admissions. The new tests, offered by Genelex Corporation, 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 individuals DNA, rather than prescription by trial and error. The age of "one dose fits all" is ending," Genelex CEO Howard Coleman stated.
To help educate physicians and patients about the test, Genelex has launched a new, free, Internet presentation that details how DNA tests can reduce potentially fatal side effects connected to warfarin. The site also includes computerized information to help patients AND physicians interpret test results.
The Genelex test is simple, requiring no more effort than vigorously rubbing the inside of the cheek with a cotton-tipped swab and sending it to Genelex's laboratory for testing. No prescription is needed, and insurance often pays for the test.
Many experts agree that the use of DNA testing will dramatically improve the safety and efficacy of warfarin.
For further information, consumers can view the Coumadin (warfarin) Web Seminar free of charge by going to http://www.genelex.com/. Information about test purchase and interpretation of test results is also available at Genelex.com. Further questions on this release should be directed to Genelex CEO Howard Coleman, 800 523-3080.
Genelex Corporation
CONTACT: Howard Coleman of Genelex Corporation, +1-800-523-3080
Web site: http://www.genelex.com/
Source: PRNewswire
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