WHO Pharmaceuticals Newsletter 2003, No. 03
(2003; 14 pages) View the PDF document
Table of Contents
View the documentACETYLSALICYLIC ACID - MHRA confirms labelling change
View the documentACITRETIN - Warnings of depression added to label
View the documentASTEMIZOLE - Withdrawn due to life-threatening ventricular arrhythmias
View the documentCAMELIA SINENSIS - Ethanolic extract products withdrawn due to hepatotoxicity
View the documentDIETARY SUPPLEMENTS - Withdrawal of two products due to presence of sildenafil
View the documentHUA FO - Presence of tadalafil
View the documentIODINE - Some products contain more than the RDA
View the documentLEVODOPA/CARBIDOPA - New warning about somnolence and sudden onset sleep
View the documentLINDANE - Additional warnings and medication guide added to label
View the documentNEFAZODONE - Regulatory status update
View the documentNIMESULIDE - Paediatric preparations banned in Bangladesh
View the documentPERGOLIDE MESYLATE - Risk of cardiac valvulopathy
View the documentREPAGLINIDE - Contraindicated with gemfibrozil
View the documentRISPERIDONE - Prescribing information updated to reflect cardiovascular adverse events
View the documentTELITHROMYCIN - Aggravation of myasthenia gravis
Open this folder and view contentsSAFETY OF MEDICINES
Open this folder and view contentsCURRENT CONCERNS
Open this folder and view contentsDRUGS OF INTEREST
Open this folder and view contentsFEATURE

CAMELIA SINENSIS - Ethanolic extract products withdrawn due to hepatotoxicity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

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