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FDA backs new warning on Tamiflu


The most widely used flu drug in the world should carry stronger warnings on its label about psychiatric problems experienced by patients, according to health officials in the US.

A panel of experts to the Food and Drug Administration (FDA) recommended that Roche, the drug’s manufacturer, should alter the wording on Tamiflu’s warning label.

It already mentions reports of delirium and self-injury, primarily among children in Japan, but some of the FDA’s experts suggested it should also mention that several patients have died as a result of these abnormal behaviours.

While the FDA’s advisers agreed stronger warnings are needed, they said that it is unclear whether the psychiatric problems are a side-effect of the drug or the flu itself. Some panellists said labelling should point out that similar deaths have also occurred in flu patients who were not receiving the medication.

Nearly 600 cases of psychiatric problems have been reported in Tamiflu patients, with 75% of them occurring in Japan. Five children in the country have died after “falling from windows or balconies or running into traffic”, according to the FDA.

Japanese health authorities are scheduled to hold their own meeting on Tamiflu’s safety next month.

Swiss-based Roche said that it had presented its own analysis of more than 150,000 patients that showed there is no connection between Tamiflu and increased risk of psychiatric problems.

The drug has been used by 48 million patients since it was launched in 1999.

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