Tamiflu, an antiviral drug used to treat flu, should be watched more closely over the next two years for potential health problems when used in children, a US regulatory panel recommended on Friday.
The Food and Drug Administration experts panel also determined that there was no clear link between Tamiflu, which is made by the Swiss drugmaker Roche, and deaths and health problems among some users. The panel, which makes recommendations for agency regulations, reviewed extensive Tamiflu data, particularly Japanese regulatory reports of 12 deaths among 75 cases of serious symptoms in children.
Dr Robert Nelson, chairman of the US paediatric advisory panel, said: “The committee does not think, based on the data presented, that there is any evidence Tamiflu played a role in the deaths.”
Roche also pledged to work with regulators in ongoing monitoring for signs of unusual symptoms or health problems in children taking the drug.
The panel’s review was closely watched because of the drug’s importance in plans to guard against a global flu pandemic.
Tamiflu is a key treatment in government and medical preparations for a potential pandemic. The drug, which helps fight the virus after infection, has been in hot demand since concerns spread over bird flu outbreaks, and as governments try to build stockpiles.
But the the committee data review also highlighted the FDA’s new, quicker reflexes to air publicly concerns over drug safety. Scrutiny over the agency’s drug safety system intensified after Merck’s withdrawal of Vioxx, the US drugmaker’s blockbuster pain medication, last year.
Dr Linda Lewis, from the FDA’s antiviral drug division, told the committee that the agency was trying to be pro-active after seeing the Japanese data. “We’re trying to be as transparent as possible, and as thorough as possible,” she said.
The committee voted unanimously for the FDA to give it a preliminary update next year on adverse events in Tamiflu users, and a full report two years from now.
It also discussed a possible look at the drug’s pharmacology in children, and more detailed information on children exhibiting problems.
Tamiflu is widely used in Japan - three times more than the rest of the world combined. The FDA committee said better US monitoring would help determine whether Japan’s use and safety system provided an early signal for deaths, brain illnesses and other psychiatric symptoms in other populations.
Roche presented clinical trials data and an epidemiological review showing Tamiflu users had fewer or equal number of instances of such symptoms and deaths as children given placebo.