alex revision
March 14th, 2010, 02:07 PM
Plavix receives new 'black box' warning
Sun, 14 Mar 2010 15:53:47 GMT
http://www.presstv.com/detail.aspx?id=120818§ionid=3510210
FDA officials have added a new warning label to the anti-clotting drug Plavix, stressing that not metabolizing the pill may cause non-responsiveness in some patients.
Plavix, the second most commonly used blood thinner, is believed to reduce the risk of heart attack, unstable angina, stroke and cardiovascular death in patients with heart disease.
The drug can only cause its effect after being metabolized into its active form by the liver enzyme, CYP2C19.
According to a statement recently released by the FDA, normal doses of Plavix are potentially ineffective in some 2 to 14 percent of individuals, also known as "poor metabolizers."
Such patients carry two copies of the CYP2C19 gene and hence are not able to convert Plavix into its active form. "Because the patient makes less of the active form there is less anti-platelet effect in the blood and the patient may not receive the full benefit of Plavix treatment," said Mary Ross Southworth of the FDA Center for Drug Evaluation and Research.
Officials, therefore, urge physicians to identify such patients with special genetic tests and treat them with alternative medication.
They, however, recommended patients continue taking their pills unless they are prohibited from doing so by their healthcare professional.
Sun, 14 Mar 2010 15:53:47 GMT
http://www.presstv.com/detail.aspx?id=120818§ionid=3510210
FDA officials have added a new warning label to the anti-clotting drug Plavix, stressing that not metabolizing the pill may cause non-responsiveness in some patients.
Plavix, the second most commonly used blood thinner, is believed to reduce the risk of heart attack, unstable angina, stroke and cardiovascular death in patients with heart disease.
The drug can only cause its effect after being metabolized into its active form by the liver enzyme, CYP2C19.
According to a statement recently released by the FDA, normal doses of Plavix are potentially ineffective in some 2 to 14 percent of individuals, also known as "poor metabolizers."
Such patients carry two copies of the CYP2C19 gene and hence are not able to convert Plavix into its active form. "Because the patient makes less of the active form there is less anti-platelet effect in the blood and the patient may not receive the full benefit of Plavix treatment," said Mary Ross Southworth of the FDA Center for Drug Evaluation and Research.
Officials, therefore, urge physicians to identify such patients with special genetic tests and treat them with alternative medication.
They, however, recommended patients continue taking their pills unless they are prohibited from doing so by their healthcare professional.