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Dr. Kim Mulvihill Reporting This Thursday an FDA advisory panel will discuss whether to put a warning label on the anti-viral drug Tamiflu. The concern is over reports of bizarre behavior - including some deaths - in children treated with the prescription medication.
Millions of doses of Tamiflu have been stockpiled around the world as a defense against a possible flu pandemic. The anti-viral can lessen the severity and cut the duration of the flu.
Tamiflu is a big seller in Japan, where it's used for seasonal flu outbreaks. In fact, ten times as many prescriptions are written in Japan as in America. But now because of new information from Japan, federal health officials are considering changes to the Tamiflu label in the US.
The changes would warn of possible abnormal behavior and recommend that all patients taking the drug, especially children, be closely monitored. The FDA does not know if Tamiflu, the flu virus, or a combination of both are responsible. Over a 10-month period more than 100 new cases of bizarre behavior -- most involving children from Japan -- were reported to the FDA, including three deaths from falls.
The bizarre behavior included delirium, hallucinations, delusions and convulsions.
The manufacturer stands by its product, saying, "Tamiflu was demonstrated in clinical trials to be a safe and effective medication for influenza prevention and treatment. It has been used by more than 42 million people in over eighty countries.
