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FDA Gives Plavix New Box Warning Relating to Metabolization in the Body – Step One Toward Personalized Medicine

Posted Mar 12 2010 4:05pm

As mentioned in prior posts, is Plavix a good candidate for personalized medicine, since it is a blood thinner.  Right now with the new warning, it is basically telling image you that it might not work for you so with a test perhaps the guess work someday could be eliminated. 

Will Plavix be the next drug up for a genetic test?  There are not many alternative drugs either that could easily replace the functionality of Plavix, it is a blood thinner.   One idea would be to monitor patients with poor liver or kidney metabolization. as suggested here , a blog written by Steve Murphy, MD of New York who has a personalized medicine practice, and thus electronic records would help the cause here tremendously as manually if a practice has a substantial amount of patients, it would be a nightmare.  BD

Plavix – What’s the next step for doctors and patients – possible genetic testing in the near future?

SILVER SPRING, Md., March 12 /PRNewswire-USNewswire/ -- The U.S. Food and Drug Administration today added a boxed warning to the anti-blood clotting drug Plavix (clopidogrel), alerting patients and health care professionals that the drug can be less effective in people who cannot metabolize the drug to convert it to its active form. 

Plavix reduces the risk of heart attack, unstable angina, stroke, and cardiovascular death in patients with cardiovascular disease by making platelets less likely to form blood clots. Plavix does not have its anti-platelet effects until it is metabolized into its active form by the liver enzyme, CYP2C19.

n May 2009, the FDA added this warning to the drug's label. After reviewing more data, the agency felt it was important to highlight this risk in a boxed warning.

It is estimated that 2 percent to 14 percent of the U.S. population are poor metabolizers. The FDA recommends that health care professionals consider alternative dosing of Plavix for these patients, or consider using other anti-platelet medications. Tests are available to assess CYP2C19 genotype to determine if a patient is a poor metabolizer.

Patients should not stop taking Plavix unless told to do so by their health care professional. They should talk with their health care professional if they have any concerns about Plavix.

Plavix is made under a Bristol-Myers Squibb - Sanofi Pharmaceuticals partnership.

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