The Pharmaceutical Journal
Vol 275 No 7377 p654
26 November 2005

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European Medicines Agency(website)

Safety data on Tamiflu requested by EMEA

A cumulative safety review of all available data on serious psychiatric disorders involving Roche’s antiviral drug oseltamivir (Tamiflu) has been requested by the European Medicines Agency (EMEA).

The request follows two alleged suicides in boys taking oseltamivir reported to the EMEA. “So far, no causal relationship has been identified between the use of Tamiflu and psychiatric symptoms (such as hallucination and abnormal behaviour),” said the EMEA. It stressed that assessment of psychiatric events during oseltamivir treatment is difficult because other medicines are often taken at the same time, and patients with influenza and a high temperature can show psychiatric symptoms.

The EMEA will evaluate the information supplied by Roche and will make a statement on its findings in due course.

FDA review The safety of oseltamivir in children has been confirmed by the paediatric advisory committee of the US Food and Drug Administration following its review of data. Chairman of the committee, Robert Nelson, said that the committee found no evidence that oseltamivir played a role in the reported deaths of 12 children with influenza in Japan.