Call it the FDA's official ushering-in of the gene-tailored drug era. The agency is suggesting that doctors examine their patients' genetic profiles before prescribing the anticoagulant warfarin, which can cause bleeding complications in some people. Warfarin is prescribed to some 2 million annually, and results in about 30,000 E.R. visits each year.
The FDA isn't ordering doctors to do so, but the suggested testing is incorporated in the drug's label. It's the first time the agency has included language about genetic profiling in such a widely used drug. People with unusual variations in two key genes - one that regulates metabolism and one that determines sensitivity to warfarin's blood-thinning mechanism - should be started at lower doses, experts say.
- here's the article [1] from The Washington Post
- see the FierceBiotech report [2]
Related Articles:
Diagnostics tied to new drugs. Report [3]
Personalized medicine advances with new genetic test. Report [4]
The brave new world of personalized medicine. Report [5]
Genetic testing advances as insurers balk. Report [6]
Links:
[1] http://www.washingtonpost.com/wp-dyn/content/article/2007/08/16/AR2007081602323.html?hpid=sec-health
[2] http://www.fiercebiotech.com/story/warfarin-label-change-spotlights-molecular-diagnostics/2007-08-16
[3] http://www.fiercebiotech.com/story/diagnostics-tied-to-new-drugs/2006-01-03
[4] http://www.fiercebiotech.com/story/personalized-medicine-advances-with-new-genetic-test/2007-02-07
[5] http://www.fiercebiotech.com/story/live-from-bio-biopharmas-talk-partnerships/2006-04-11
[6] http://www.fiercebiotech.com/story/genetic-testing-advances-as-insurers-balk/2007-01-03