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Ver el documentoASTEMIZOLE - Withdrawn due to life-threatening ventricular arrhythmias
Ver el documentoCAMELIA SINENSIS - Ethanolic extract products withdrawn due to hepatotoxicity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

REPAGLINIDE - Contraindicated with gemfibrozil

Europe. The European Medicinal Products Evaluation Agency (EMEA) has issued a public statement about an interaction between repaglinide (Novonorm/Prandin), a medicine used to lower blood sugar in diabetic patients, and gemfibrozil, a lipid- lowering agent. The blood glucose lowering effect of repaglinide maybe markedly enhanced and prolonged when administered together with gemfibrozil, with an increased risk of severe hypoglycaemia. The Agency has received 5 reports of serious adverse hypoglycaemic episodes in patients using repaglinide and gemfibrozil at the same time. Therefore, the EMEA’s Committee for Proprietary Medicinal Products (CPMP) has decided to contraindicate the concomitant use of these two drugs. Patients already receiving repaglinide and gemfibrozil should be reviewed and put under alternative combination treatment with close monitoring of diabetic status. The repaglinide Summary of Product Characteristics (SPC) and the product package leaflet have been appropriately modified to reflect the above mentioned contraindication.

EMEA Public Statement (EMEA/11700/03), 21 May 2003. Available from URL: http://www.emea.eu.int

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