The European Medicines Agency has backed the safety of Roche’s flu drug Tamiflu (oseltamivir), recommending its use for the prevention of influenza in children aged one to 12 years. The Agency also said it did not deem it necessary to add extra safety warnings to the drug’s label, after a review failed to link use of the drug with psychiatric disorders.
This closely follows a similar move by US regulators, which carried out a review of the deaths of 12 children in Japan and a potential link to the development of psychiatric conditions with use of Tamiflu. But 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, and Roche says it expects the US nod in early 2006.
Tamiflu, which works by blocking an enzyme on the surface of the flu virus, thereby preventing infection of other cells in the body, is already cleared for treating influenza in adults and children aged 13 or over, and could prove to be an effective weapon in preventing flu in very young children, especially vulnerable to the illness. "This is particularly helpful in the family setting when one member of the family catches influenza during an outbreak of the disease," commented Eduard Holdener, Roche’s head of global pharma development.
Under global preparedness plans for an outbreak of avian flu, which some fear could wipe out millions of people, Tamiflu is currently being stockpiled by governments to fight help protect against spread of the virus, should an outbreak occur. Roche says it has now met orders from around 50 countries for the agent, and has agreed to outsource its production to continue to meet burgeoning demand for the drug.