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New clinical trials for Tamiflu

Roche and Japanese subsidiary Chugai will carry out new clinical trials on its avian flu drug Tamiflu to investigate a possible link between the drug and reports of suicides and injuries among Japanese teenagers

Swiss pharmaceutical company Roche and its Japanese subsidiary Chugai Pharmaceutical will carry out new clinical trials on its avian flu drug Tamiflu (oseltamivir). The trials aim to establish whether there is a possible link between the drug and a number of suicides and injuries among Japanese teenagers.

The Japanese health ministry drug safety panel has recommended the new trials over fears it could be linked to several teenagers who have committed suicide or harmed themselves are taking the drug. A teenage boy and girl fell to their deaths in February 2007.

ìChugai will proactively investigate whether there is anything characteristic in the background, the timing, and the pattern of onset of abnormal behaviours, by further analyzing the information gathered on adverse events,î the company said in a statement.

The new research will involve clinical trials on humans to determine the effect of Tamiflu on sleep and its administration and transport to cerebrospinal fluid.

Toxicity studies will also be carried out on rats to detect the drug's effect on behaviour and the brain.

The ministry revealed this week that the number of people who have behaved abnormally after taking Tamiflu has risen to 211 from 128 in April 2007.

ìWe are putting increasingly more effort into investigating whether there is any causality and are investigating possible safety measures,î said Chugai.

Japan is a huge market for Tamiflu with Chugai supplying 10.8m patients with Tamiflu in the 2004-2005 flu season. Tamiflu sales rose by eight per cent in 2006 to JPY 38bn (EUR 234.1m). Chugai expects sales to fall by 23 per cent in 2007.

20th June 2007

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