WHO Pharmaceuticals Newsletter 2003, No. 05
(2003; 15 pages) View the PDF document
Table of Contents
Close this folderREGULATORY MATTERS
View the documentASTEMIZOLE - Withdrawn due to ventricular arrhythmias
View the documentBICALUTAMIDE - Withdrawn due to accelerated deaths
View the documentDACLIZUMAB - Warning about hypersensitivity reactions, increased mortality in cardiac transplant study
View the documentDANAZOL - Use restricted to second-line therapy in endometriosis
View the documentLEVACETYL-METHADOL - Product to be withdrawn due to adverse cardiac events; safer alternatives to be adopted
View the documentMOROCTOCOG ALFA - Reports of lack of effect in prophylaxis patients
View the documentNEFAZODONE - Sale discontinued due to adverse hepatic events
View the documentNIMESULIDE - Product under ‘special pharmacovigilance’
View the documentOSELTAMIVIR - Adverse reactions section to include acute renal failure, thrombocytopenia, leucopenia
View the documentPHENYLPROPAN-OLAMINE - New warnings on cardiovascular risks to be added
View the documentSOMATROPIN - Refused approval for use in AIDS-related wasting syndrome
View the documentTERFENADINE - Withdrawn due to ventricular arrhythmias
View the documentVALSARTAN - Reports of interstitial pneumonia
Open this folder and view contentsSAFETY OF MEDICINES
Open this folder and view contentsDRUGS OF INTEREST
Open this folder and view contentsFEATURE
Open this folder and view contentsMISCELLANY
 

OSELTAMIVIR - Adverse reactions section to include acute renal failure, thrombocytopenia, leucopenia

Japan. The Pharmaceuticals and Food Safety Bureau’s Safety Division has advised that acute renal failure, leucopenia and thrombocytopenia should be added as clinically significant adverse reactions to the product insert of oseltamivir (Tamiflu) indicated in the treatment of influenza. These additions are based on reports associating oseltamivir (Tamiflu) use with acute renal failure and acute hepatitis. It is recommended that patients be carefully observed upon onset of acute renal failure and appropriate measures taken immediately if any abnormalities occur. In case of leukopenia and thrombocytopenia, the drug should be discontinued.

Reference:
Pharma Japan 1859, 8 Sept 2003.

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