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Yesterday the U.S. Food and Drug Administration voted to revise the labels of the popular flu medications Tamiflu and Relenza. The new warnings will inform consumers of possible psychiatric problems associated with the drugs. There have been numerous reports of delirium and hallucinations tied to the drug, the majority coming from Japan, but no causal relationship has been confirmed. The new label will touch on the fact that intense flu can trigger psychiatric events.

Nearly 600 cases of psychiatric problems have been reported in Tamiflu patients, with 75 percent of them coming from Japan. Five children there have died after “falling from windows or balconies or running into traffic,” according to the FDA.

The highest risk seems to be associated with children and adolescents. At least 25 patients under the age of 21 have died while taking Tamiflu. There have been no child deaths connected to Relenza, but neurological problems have been seen.

Tamiflu’s manufacturer, Roche, presented analysis of over 150,000 patients that showed no link between increased psychiatric events and their drug.

Tamiflu is one the most popular flu medications in the world with over $1.1 billion in sales over the first half of this year. Bird flu pandemic scares in recent years have benefited the company, increasing sales through government stockpile programs.

For more information on this subject, please refer to the section on Drugs, Medical Devices, and Implants.

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