Methyl Chloride Contamination Found in Generic Clopidogrel
Major Finding: Eleven different generic formulations of clopidogrel contained methyl chloride contamination at levels of 10 ppm to more than 100 ppm. Samples of brand-name clopidogrel (Plavix) contained no detectable methyl chloride.
Data Source: Headspace gas chromatography testing of samples from 11 different formulations of generic clopidogrel obtained in Europe or India, and brand-name clopidogrel.
Disclosures: Dr. Thethi and his associates at Loyola said they had no disclosures. Their collaborators from Sanofi Aventis were all employees of the company that markets clopidogrel (Plavix).
FROM THE ANNUAL SCIENTIFIC SESSIONS OF THE AMERICAN HEART ASSOCIATION
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,” Dr. Gurbel queried.
Dr. Thethi and his associates at Loyola said they had no disclosures. Their collaborators from Sanofi-Aventis were all employees of the company that markets clopidogrel (Plavix).
Dr. Gurbel has been a consultant to, and received honoraria and research grants from AstraZeneca, Bayer, Daiichi Sankyo, Lilly, Portola, Pozen, Sanofi-Aventis, and Schering Plough.
