WHO Pharmaceuticals Newsletter 2003, No. 03
(2003; 14 pages) Ver el documento en el formato PDF
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Cerrar esta carpetaREGULATORY MATTERS
Ver el documentoACETYLSALICYLIC ACID - MHRA confirms labelling change
Ver el documentoACITRETIN - Warnings of depression added to label
Ver el documentoASTEMIZOLE - Withdrawn due to life-threatening ventricular arrhythmias
Ver el documentoCAMELIA SINENSIS - Ethanolic extract products withdrawn due to hepatotoxicity
Ver el documentoDIETARY SUPPLEMENTS - Withdrawal of two products due to presence of sildenafil
Ver el documentoHUA FO - Presence of tadalafil
Ver el documentoIODINE - Some products contain more than the RDA
Ver el documentoLEVODOPA/CARBIDOPA - New warning about somnolence and sudden onset sleep
Ver el documentoLINDANE - Additional warnings and medication guide added to label
Ver el documentoNEFAZODONE - Regulatory status update
Ver el documentoNIMESULIDE - Paediatric preparations banned in Bangladesh
Ver el documentoPERGOLIDE MESYLATE - Risk of cardiac valvulopathy
Ver el documentoREPAGLINIDE - Contraindicated with gemfibrozil
Ver el documentoRISPERIDONE - Prescribing information updated to reflect cardiovascular adverse events
Ver el documentoTELITHROMYCIN - Aggravation of myasthenia gravis
Abrir esta carpeta y ver su contenidoSAFETY OF MEDICINES
Abrir esta carpeta y ver su contenidoCURRENT CONCERNS
Abrir esta carpeta y ver su contenidoDRUGS OF INTEREST
Abrir esta carpeta y ver su contenidoFEATURE

CAMELIA SINENSIS - Ethanolic extract products withdrawn due to hepatotoxicity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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