IS THE FDA'S INVESTIGATION OF CHANTIX (VARENICLINE) TOO LITTLE TO LATE?

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DRUG INTERACTIONS BETWEEN CHANTIX (VARENICLINE) AND WARFARIN (COUMADIN)
A study by Pfizer Global Research & Development investigated the effect of varenicline (CHANTIX) on the pharmacokinetics and pharmacodynamics of a single dose of warfarin in 24 adult smokers

Pharmacokinetic parameters fOR warfarin (COUMADIN) and international normalized ratio (INR) values were determined.

Varenicline was assessed as an inhibitor and inducer of human cytochrome P450 activities using liver microsomes and hepatocytes, respectively.

Consistent with the in vitro data, no alteration in human pharmacokinetics of COUMADIN was observed with CHANTIX treatment.

COUMADIN pharmacodynamic parameters, maximum INR, and the area under the prothrombin (INR)-time curve, were also unaffected by varenicline.

Concomitant administration of varenicline and warfarin was well tolerated.

Consequently, warfarin can be safely administered with varenicline without the need for dose adjustment.[...].

• Burstein AH, et al. Lack of pharmacokinetic and pharmacodynamic interactions between a smoking cessation therapy, varenicline, and warfarin: an in vivo and in vitro study. J Clin Pharmacol. 2007 Nov;47(11):1421-9.

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