FDA Committee Supports Simple DNA Tests when Patients are Prescribed Warfarin
News Nov 28, 2006
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.
According to the FDA, hemorrhage during warfarin therapy is a one of the 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 tests, offered by Genelex Corporation allow physicians to 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.
Many experts agree that the use of DNA testing will dramatically improve the safety and efficacy of warfarin.
In treating inflammatory bowel disease (IBD), physicians can have a hard time telling which newly diagnosed patients have a high risk of severe inflammation or what therapies will be most effective. Now researchers report finding an epigenetic signature in patient cells that appears to predict inflammation risk in a serious type of IBD called Crohn’s disease.