(2003; 15 pages)
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.
Pharma Japan 1859, 8 Sept 2003.