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FDA clears Tamiflu in children after safety scare

Published on 22/11/05 at 02:35pm

The FDA says there is no evidence that Tamiflu was linked to the death of 12 children taking the antiviral drug.

The US regulator's conclusion follows an in-depth review by its Paediatric Advisory Committee (PAC), which looked at the drug's clinical trial data and reports of adverse events linked to Tamiflu, including the 12 deaths, which all occurred in Japan.

The Tamiflu inquiry was part of a routine review of newer medicines prescribed to children, but coincides with huge interest in the drug, which is being stockpiled around the world as a frontline defence against a possible avian flu pandemic.

Dr Robert Nelson, chairman of the committee, said there was no concern at all that Tamiflu played a role in the reported deaths of children with influenza in Japan.

The FDA said it would continue to monitor the safety of Tamiflu for use in children, but found no reason for changing the labelling of the product for neuropsychiatric issues.

Despite the all-clear, manufacturer Roche says it intends to work with the FDA to change Tamiflu's labelling based on adverse skin reactions which have occurred in a small number of patients, mostly in Japan.

"We welcome the outcome of the FDA advisory committee and look forward to working with the FDA and other health authorities to extend our knowledge of the use of Tamiflu and its safety profile," said William Burns, head of Roche's pharmaceutical division.

The EMEA, meanwhile, is conducting its own investigation into Tamiflu's use in children and has requested all available data on serious psychiatric disorders from Roche.

The EMEA review follows two cases of alleged suicide associated with Tamiflu reported to the European regulator.

Like the FDA, the EMEA said it was difficult to tell whether Tamiflu was linked to the fatalities but has yet to make a statement following its evaluation.

It said that patients often take other medication at the same time as Tamiflu and those suffering from influenza and a high fever can show psychiatric symptoms, particularly children.

Since Tamiflu (oseltamivir) was approved in 1999, 12 children under the age of 16 have died while 32 have suffered neuropsychiatric events, including hallucinations, convulsions and brain inflammation.

The deaths and the majority of adverse reactions, including skin rashes, have been reported in Japan, where Tamiflu is widely prescribed.

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