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Image header Agence Europe
Europe Daily Bulletin No. 9072
Contents Publication in full By article 22 / 39
GENERAL NEWS / (eu) eu/health

EMEA and FDA ask Roche for additional data on Tamiflu

Brussels, 21/11/2005 (Agence Europe) - In a press release published on 17 November, the European Agency for the Evaluation of Medicinal Products (EMEA) reconsiders the harmlessness of the antiviral drug Oseltamivir, which is sold by the Swiss laboratory Roche under the name Tamiflu. Whilst indicating its awareness of two cases of death by suicide associated with the taking of this drug (a 17 year old adolescent in February 2004 and a 14-year-old boy in February 2005), the Agency attempted to mollify the citizens, commenting that both young men had a history of disturbed behaviour. However, the Agency has called upon Roche to provide it with data on psychiatric disorders and of all deaths which have occurred under Tamiflu. This press release was published on the same day as the Federal Drug Administration (FDA) of the United States published a report on its web site about the deaths of 12 children treated with this drug in Japan between March 2004 and April 2005. According to the report, although it is difficult to establish a link between the deaths and the use of Tamiflu, the FDA has called for additional information from the Basel-based laboratory. The Japanese health authorities have already issued a warning about the risk of behavioural disturbances.

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