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Tamiflu Warnings Should Be Stronger for Child Use

Posted by Jane Akre
Tuesday, November 27, 2007 7:19 PM EST
Category: Major Medical, Protecting Your Family
Tags: defective drugs, FDA & prescription drugs, Defective & dangerous products

For more on Tamiflu, see InjuryBoard's Tamiflu information page.

FDA information page

CDC information page
An FDA advisory panel says the anti-flu drugs Tamiflu (oseltamivir) and Relenza (zanamivir ) should carry a stronger warning about the possible side effects for children including delirium, hallucinations, psychotic behavior and death.

It concludes that the present label for Tamiflu is not specific enough in its warnings. 

Last year drug maker Roche changed the warning on its product insert saying “people with the flu, particularly children, may be at an increased risk of self-injury and confusion shortly after taking Tamiflu.”  It added that behavior changes among users should be monitored.

The risks are reported to be rare and may be the result of the drug interacting with flu symptoms. Since 1999 about 2.85 million Tamiflu prescriptions have been written in the U.S. 

After today's announcement a spokesman for Roche said Tamiflu is safe and reduces the incidents of the flu after initial symptoms appear.  The company says it also reduces the risk of flu if there is a pandemic outbreak.   

Tamiflu was approved by the FDA in December 2005 for use in children ages one to 12, despite the fact that  bizarre behavior reports began coming in from Japan that year.   

In that country, five adolescents died of traumatic injuries from falling out of a window or running into traffic.  That country’s health minister recommends young people not take Tamiflu unless they are experiencing severe complications from the flu.

Earlier this month an FDA panel found no link between Tamiflu and the deaths in Japan.

There have been no deaths reported with the use of Relenza, though the stronger warning suggestions apply to its waning label as well.  The FDA does not have to follow the advisory panel's recommendations, though it usually does.

Sales of Tamiflu have dropped in Japan to about five million prescriptions from a high of 9 million prescriptions two years ago.

Each year 36,000 people die and 200,000 are reportedly hospitalized as a result of the flu. The young and elderly are particularly susceptible.

A study in the New England Journal of Medicine found that two patients died despite being given Tamiflu and concludes that use of the drug might lead to a drug resistant strain of the disease. 

Roche began expanding production of Tamiflu in March 2006 after reaching agreements with 65 countries to begin stockpiling the drug in the event of an avian flu outbreak.

At the same time, Former Defense Secretary Donald Rumsfeld, who sat on the board that discovered the drug,  divested himself of $5 million in stock.  He left the board in 2001 but retained a huge shareholding.  

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