FDA dismisses Tamiflu concerns

Tamiflu was already scheduled to be reviewed after it was approved for use in children in March 2004, but the evaluation took on greater significance following the deaths of 12 Japanese children who had been taking the anti-flu drug.

The FDA indicated that it intends to continue normal monitoring of the safety of Tamiflu for use in children, but found no basis for changing the labeling of the product for neuropsychiatric issues. Roche intends to work with the FDA to change the drug’s labeling based on adverse skin events that have occurred in a small number of patients, mostly in Japan.

According to Dr Robert Nelson, chairman of the committee, there is “no concern at all” that Tamiflu played a role in the reported deaths of the children with influenza in Japan. Dr Nelson is an associate professor in the department of anesthesia and critical care at The Children’s Hospital of Philadelphia.

“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,” commented William Burns, CEO of Roche Pharma Division.