Tamiflu Will Carry Stronger Warning Labels

Maker will beef up language on possible psychiatric side effects
By Jim O'Neill,  Newser User
Posted Nov 28, 2007 4:51 PM CST
An employee of the pharmaceutical combination Roche in Kaiseraugst, Switzerland, supervises the production of the pharmaceutical "Tamiflu", pictured on Sept. 22, 2006.   (Associated Press)
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(Newser) – The maker of flu drug Tamiflu said today it will accept recommendations by a government panel that it revise printed warnings about the medication's side effects. Labels already warn of possible psychiatric reactions, but the panel recommended noting that some people have died, the AP reports. Drugmaker Roche says flu alone can trigger problems such as delirium and wants the labels to make that clear as well.

The FDA panel recommended that Roche add "cautionary language" after a spate of reports, mostly from Japan. The agency issued similar recommendations on Relenza, a flu drug produced by GlaxoSmithKline. Roche says its own research links psychiatric episodes to flu and not its drug. "Data increasingly points to the role of influenza in these events," a Roche rep says.