A US Food and Drug Administration (FDA) advisory committee has backed the safety of Roche’s influenza drug Tamiflu (oseltamivir) after the product was linked to serious side effects, including deaths, last week.
According to Robert Nelson, chairman of the Pediatrics Advisory Committee, there is “no concern at all” that Tamiflu played a role in the reported deaths of children with influenza in Japan. Tamiflu was one of eight products under evaluation by the panel at the meeting.
The PAC said on Friday that it could see no direct link between Tamiflu and the deaths of 12 children in Japan, but urged that continued monitoring of the drug be carried out to evaluate any potential risks. It said another session should be convened in around a year and after two years to review this surveillance data.
The in-depth evaluation into Tamiflu was prompted by an investigation by the Japanese health ministry into behavioural side effects and some skin and hypersensitivity reactions seen in patients taking Tamiflu, and is particularly pressing because millions of doses of the product are being stockpiled around the world as governments attempt to prepare for a possible flu pandemic.
While clearing Tamiflu of any link to the deaths and behavioural effects linked to the drug, the committee did ask for some changes to Tamiflu’s labeling. It suggested that existing warnings of skin reactions be updated to reflect new information compiled by the regulatory authorities in Japan, where usage of the flu drug has been particularly high.
IMS Health data suggests that around 24.4 million prescriptions for oseltamivir were dispensed in Japan between 2001 and 2005, compared to approximately 5.5 million prescriptions in the USA.
The European Medicines Agency last also asked for additional data from Roche on the drug last week, although it stressed at the time that no causal relationship has been seen between the drug and the behavioural symptoms.
In the USA, Roche has filed for approval to extend the age range eligible for treatment with Tamiflu to include children aged between one and 12.