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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

(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.

An employee of the pharmaceutical combination Roche in Kaiseraugst, Switzerland, supervises the production of the pharmaceutical "Tamiflu", pictured on Sept. 22, 2006. (Associated Press)

An undated company photo provided by Swiss pharmaceutical concern Roche Products shows a worker supervising the package of the Tamiflu, the drug that combats the effects of bird flu in humans. (Associated Press)

A box of Tamiflu is shown in this Feb. 9, 2007 file photo in Shanghai, China. (Associated Press)

A warehouse operator removes samples of Tamiflu drugs to be photographed at a manufacturer's warehouse Friday, March 30, 2007 in Singapore. (Associated Press)

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Tamiflu Will Carry Stronger Warning Labels

Maker will beef up language on possible psychiatric side effects

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FDA Restricts Diabetes Drug Over Heart Risk

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Agency flags flawed study, may ban diabetes drug

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Tamiflu Will Carry Stronger Warning Labels

Maker will beef up language on possible psychiatric side effects

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OTHER STORIES ON OUR RADAR

FDA • GlaxoSmithKline • Tamiflu • Relenza • flu medications • Roche

MOST POPULAR STORIES

[ By Views ]

[ By Comments ]

More Newser Stories

FDA Restricts Diabetes Drug Over Heart Risk

But regulators stop short of an outright ban on Avandia

FDA Panel: Keep Avandia on Market

But it may get warning label on heart risks

Avandia Woes Mount Ahead of FDA Hearing

Agency flags flawed study, may ban diabetes drug

Diabetes Drug Linked to Heart Woes Again; FDA Weighs Ban

Avandia less safe than alternatives; FDA weighs action

Feds Further Link Avandia to Heart Risk

FDA, Senate reports lambaste GlaxoSmithKline, want to yank drug

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