Tamiflu not linked to psychiatric disorders

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European regulators on Thursday gave Roche’s Tamiflu (oseltamivir) the all clear of causing psychiatric problems and recommended the drug’s use be extended to include preventing flu in children.

“A review by the European Medicines Agency (EMEA) of new safety data for Tamiflu has concluded that there is no new safety signal relating to psychiatric disorders while taking Tamiflu and therefore no change to the product safety information of Tamiflu is needed,” the agency said in a statement.

The all clear comes after the EMEA announced an investigation into the drug in mid November, following two cases of possible suicidal behaviour in teenagers in Japan who had taken the antiviral drug.

In Japan, warnings have been added to the product’s label and doctors have been alerted to the possible link by Roche’s Japanese partner, Chugai.

However the EMEA said that at its request, close monitoring of psychiatric disorders had been in place for Tamiflu since February 2003 but this would now end because the investigation had failed to uncover any evidence of a problem.

The CHMP also recommended extending Tamiflu use to include flu prevention in children between 1 and 12 years old. The drug is already approved for treatment of flu in all ages but was not licensed for prevention in children younger than 13.

In other positive opinions, the CHMP recommended an extension to Merck & Co’s Invanz, (ertapenem) to include skin and soft tissue diabetic foot infection, in addition to its existing use in bacterial infections.

The recommendation comes after research published in The Lancet last month showed the drug was as effective as Wyeth’s Tazocin (piperacillin/tazobactam) in treating diabetic foot infection but required only one injection per day rather than four.

The CHMP also backed GlaxoSmithKline’s Rotarix for use in immunisation of infants six weeks and older against rotavirus infection.

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