(2003; 14 pages)
CAMELIA SINENSIS - Ethanolic extract products withdrawn due to hepatotoxicity
Spain, France. The French and Spanish Advisory Boards have suspended the marketing authorization of a Green Tea (Camelia Sinensis) product (Exolise), prepared from the ethanolic extract of Green Tea, due to several reports of hepatic disorders. Thirteen cases of hepatic disorders have been reported (9 in France and 4 in Spain) with this latter product (Exolise) that has been marketed by Arkopharma Laboratories in France, Belgium, Spain and the United Kingdom. All patients were women, 27 - 69 years of age, with a time to onset varying from 9 days to 5 months. 5 of the patients did not receive any other medications. Negative viral serologies were observed in 8 cases. There were 8 positive de-challenges and one positive re-challenge. The suspension order will be effective until the company provides toxicological data and additional chemical analysis of the product.
1. Communication from the Spanish Pharmacovigilance System, 11 April 2003.
2. Spanish Medicines Agency Press Release, 7 Apr 2003. Available from URL: http://www.msc.es/agemed/csmh/notas/exolise.asp