Advertisement
Thermo Scientific
Thermo Scientific

Has pharmacogenomics arrived?

The FDA yesterday linkurl:updated the label;http://www.fda.gov/bbs/topics/NEWS/2007/NEW01684.html on a widely used blood thinner, warfarin, to include information about how a patient's genes will linkurl:predict response;http://www.the-scientist.com/article/display/14864/ to the drug. Patients with certain genetic variations should receive a lower dose of the drug, according to the added text. Although a handful of drugs already note such genetic information on their labels, most of these are

By | August 17, 2007

The FDA yesterday linkurl:updated the label;http://www.fda.gov/bbs/topics/NEWS/2007/NEW01684.html on a widely used blood thinner, warfarin, to include information about how a patient's genes will linkurl:predict response;http://www.the-scientist.com/article/display/14864/ to the drug. Patients with certain genetic variations should receive a lower dose of the drug, according to the added text. Although a handful of drugs already note such genetic information on their labels, most of these are cancer drugs, which are used by a well-circumscribed set of patients. Warfarin is much more widely prescribed - about two million people start taking it each year, according to the FDA press release. Although the drug is notorious for its dosing difficulties, it has been around for more than 50 years, and doctors are used to managing dosing by trial and error. Though FDA commissioner Andrew C. von Eschenbach in the agency's statement calls the label change "one step in the FDA's commitment to linkurl:personalized medicine;http://www.the-scientist.com/article/display/18849/ ," what exactly doctors and patients are supposed to do with this genetic information is not entirely clear. A front-page linkurl:article;http://online.wsj.com/article/SB118722561330199147.html in the Wall Street Journal yesterday noted that although genetic tests can identify who has certain genetic variants, researchers have heatedly debated whether enough is known about these variations to determine what they mean for the patient. One clinical researcher quoted in the article, linkurl:Ann Wittkowsky;http://www.thrombosisclinic.com/en/11/84/373/ of the University of Washington, said that "It would be irresponsible and potentially harmful to suggest that testing be used, or even mentioned, in the label," adding that the testing is "fascinating science, but it is not yet ready for prime time."
Advertisement
Advertisement
RayBiotech
RayBiotech

Popular Now

  1. Neanderthal-Human Hybrid Unearthed
  2. Extra DNA Base Discovered
    The Nutshell Extra DNA Base Discovered

    An epigenetic variant of cytosine is stable in the genomes of living mice, suggesting a possible expansion of the DNA alphabet.

  3. Opinion: Too Many Mitochondrial Genome Papers
  4. The Brain on Fear
    The Scientist The Brain on Fear

    Scientists uncover the neurons in the mouse brain responsible for linking the sight of a looming object to scared behavior.

Advertisement
Eppendorf
Eppendorf
Advertisement
The Scientist