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EMEA issues Tamiflu warning

The European Medicines Agency (EMEA) is the latest authority to warn on the potential dangers of Roche's antiviral drug Tamiflu (olsetamivir), following warnings of neuro-psychiatric events from the Japanese government and the World Health Organisation (WHO)

The European Medicines Agency (EMEA) is the latest authority to warn on the potential dangers of Roche's antiviral drug Tamiflu (olsetamivir), following warnings neuro-psychiatric events from the Japanese government and the World Health Organisation (WHO).

The EMEA said: "It has been made aware of new reports of neuro-psychiatric adverse events occurring with the use of Tamiflu originating from Japan," referring to the recent cases of child suicides and injuries in Japan.

Its Committee for Medicinal Products for Human Use (CMPH) has now recommended that Tamiflu labels should state that ìconvulsion, depression level of consciousness, abnormal level of behaviour, hallucinations and delirium have been reported during Tamiflu administration, leading in rare cases to accidental injury. Patients, especially children and adolescents should be closely monitored and their healthcare professional should be contacted immediately if the patient shows any signs of unusual behaviour."

The EMEA and CHMP say the benefits of Tamiflu outweigh the risks, but they will continue to closely monitor any emerging safety information on Tamiflu, including neuro-psychiatric disorders. If any concerns emerge, further action will be taken.

Despite this support of sorts, Tamiflu has faced tough criticism over the past week. Doctors in Japan were warned against prescribing it to teenagers by the government because of several cases where young patients committed suicide or hurt themselves after taking it. A boy and a girl died in suspected suicides last month and two twelve-year-old boys suffered minor injuries after falling from buildings.

Chugai Pharmaceutical, Roche's subsidiary in Japan, has been told to instruct doctors not to prescribe it to anyone aged between 10 and 20 years, unless they are deemed at high risk from developing serious flu symptoms.

Roche insists the drug is safe and released clinical data last week showing there was no causal link between Tamilflu and neuropsychotic symptoms. US Clinical studies showed that children prescribed the drug as treatment for flu were less likely to display symptoms, such as delirium, delusion and self-harm than those not receiving treatment. A Japanese study also found no increase in psychiatric symptoms among patients taking Tamiflu.

Japan is a huge market for Tamiflu, with Chugai supplying 10.8m patients with Tamiflu in the 2004-2005 flu season. Tamiflu sales in Japan rose by eight per cent in FY06 to JPY 38bn (EUR 241.3m/ GBP 163.9m/ USD 323m). Chugai expects sales to fall 23 per cent in FY07. However the latest warnings are not directly affecting uptake of the drug, with Japan's Health Ministry saying it still plans to keep stockpiling the drug to tackle any possible future bird flu pandemic.

According to Roche, since 2004, over 75 countries have stockpiled Tamiflu in anticipation of a bird flu outbreak. Roche said up to CHF 1.2bn (EUR 740m/ GBP 503m/ USD 989.3m) will be spent by governments on pandemic preparation in 2008.

Analysts attributed the 2006 growth of Tamiflu more to seasonal flu treatments than pandemic preparations. Though Tamiflu sales were better than forecast, sales growth of the drug also had the impact of depressing gross margins during in the year, noted UBS analysts.

However, scientist believe that there is little expectation of a burst in avian flu outbreaks in 2007, comparable with the previous year. Bernard Vallat, the director-general of the World Organisation for Animal Health (OIE) said there is a reduced presence of the virus in the wild population following a surge in 2006.

27th March 2007

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