The report by Dr. Thethi raises concerns for me. The findings highlight two unknowns about generic clopidogrel formulations. First, is their safety because of contaminants. The second question is their pharmacodynamic equivalency to brand-name clopidogrel.
Many U.S. patients who are prescribed clopidogrel get their drug as a generic from India, Canada, or elsewhere. Patients who want to cut their costs for medications, sometimes go on the Internet and find places to buy generic clopidogrel. I know of at least one patient in my practice who buys his clopidogrel as a generic from India, and I plan to show him this new report.
I tell my patients to never use generic clopidogrel and always use the standard drug because we don’t know if the generics are pharmacokinetically and pharmacodynamically equivalent. You don’t want to guess about the efficacy of a drug like clopidogrel. It’s the No. 1, most-important drug for having pharmacodynamic equivalency because if it’s wrong, the consequences for the patient can be catastrophic. An antithrombotic agent is the most important drug we prescribe to patients who have a stent in their heart.
The findings from this new study bring to light another issue, safety. Methyl chloride is a mutagen, possible carcinogen, and liver toxin. When this drug is taken long-term, what will it mean for a patient’s safety?
Clopidogrel is unusual because it has so many different formulations available. In his talk, Dr. Thethi noted that more than a half-dozen clopidogrel salts are sold in addition to the bisulfate form of brand-name clopidogrel.
Dr. Paul A. Gurbel is director of the Center for Thrombosis Research at Sinai Hospital in Baltimore. He has been a consultant to, and received honoraria and research grants from AstraZeneca, Bayer, Daiichi Sankyo, Lilly, Portola, Pozen, Sanofi Aventis, and Schering Plough
