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Beginning in the fall of 2008, the Agency has plavix held ongoing discussions with SanofiAventis (sponsor for Plavix) for the purpose of updating Plavix labeling to describe clopidogrel’s metabolic pathway, the contribution of the CYP 450 enzyme system, variability in response related to genetic variations in CYP2C19 activity, and drug interactions with CYP2C19 inhibiting drugs .
This updated information was based on observed associations between diminished platelet response to clopidogrel and increased risk of ischemic events2,3, the linkage plavix between CYP2C19 poor metabolizer status and diminished effectiveness leading to adverse clinical outcomes1 , 4, and potential decreases in clopidogrel’s bioavailability relating to CYP450 mediated drug The agency required the sponsor to conduct further studies to develop a validated assay for measurement of clopidogrel’s active metabolite and describe its PK and PD characteristics in various CYP 2C19 metabolizer types and when given concomitantly with CYP2C19 inhibitors .
Of note, the Agency issued an Early Communication on January 26, 2009 to advise health professionals that clopidogrel’s effectiveness plavix could be affected by genetic differences in 2C19 function6,7 or other drugs that influence the way clopidogrel is metabolized .
Because there was evidence5,8 suggesting a reduction in the desired effect on platelets when omeprazole (a 2C19 inhibitor) was given with clopidogrel, the agency recommended that how long does plavix take to work indications for plavix plavix online plavix versus aspirin plavix providers re-evaluate the need for starting or continuing therapy with a PPI in patients taking clopidogrel .plavix alternative medication |
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