الخميس, 24 أيار 2012   3. رجب 1433

 

 

 

 

 

 

 

 

صورة واجمل تعليق

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القائمة البريدية

In a notice posted to its website, the FDA said a boxed warning was added
to sanofi-aventis and Bristol-Myers Squibb's Plavix (clopidogrel) to warn aboutreduced effectiveness in certain patients who metabolise the antiplatelet drug poorly
 

 In these patients, "Plavix has less effect on platelets, and therefore less ability to prevent heart attack, stroke, and cardiovascular death," the agency explained
.

The poor metabolisers, which make up 2 percent to 14 percent of the population, have a variation in the CYP2C19 liver enzyme which prevents them from effectively converting Plavix to its active form, the FDA noted
.

 The warning will inform physicians that genetic tests are available to identify these patients and it will advise healthcare professionals to consider using either "alternative dosing strategies for Plavix" or other antiplatelet agents.
 

The US regulator had added information about poor metabolisers of Plavix to the product's label in 2009, and stated that the latest decision to add the boxed warning is "based on additional data reviewed by the agency
."

Commenting on the matter, Bristol-Myers Squibb spokeswoman Laura Hortas remarked that "the revisions to the prescribing information for Plavix reflect the company's ongoing research in collaboration with the FDA, which better defines the patient population that may be affected…and alternate treatment strategies."