Japanese health authorities warned yesterday morning that the anti-influenza drug Tamiflu should not be given to teenagers, after reports that some children who took the drug exhibited bizarre behavior, according to Japanese news media.
The Kyodo news service reported from Tokyo that the Ministry of Health, Labor and Welfare had issued the new instructions on Tuesday after two 12-year-old boys taking the drug jumped from the second floors of their homes within the past two months, suffering broken legs.
But concerns have been mounting for years in Japan, where children taking Tamiflu have jumped from balconies or rushed headlong into the street. In at least a few cases the children were killed.
However, the authorities in both the US and Japan have said that it is unclear if the behavior is caused by the drug, by the flu itself or by another cause.
Ministry officials could not be reached because it was a holiday in Japan.
It was not immediately clear if the officials now believed that evidence of a link between the drug and the behavior was stronger, or if they were just deciding to err on the side of caution.
The US Food and Drug Administration said in a statement on Tuesday night that it was continuing to monitor the side effects reported in users of Tamiflu, and that it would update the drug's prescribing information in the future if warranted.
The US label for the drug already contains a precaution referring to the reports, mostly from Japan, of "self-injury and delirium" among users of Tamiflu.
"The relative contribution of the drug to these events is not known," the label says. "Patients with influenza should be closely monitored for signs of abnormal behavior throughout the treatment period."
Tamiflu, also known as oseltamivir, is used to shorten the duration of the flu.
Roche, the drug's manufacturer, defended the safety of the treatment in a statement issued on Tuesday from its headquarters in Geneva.
The company said that studies, including one coordinated by Japan's health ministry, have shown that children taking Tamiflu have a rate of neurological and psychiatric events similar to that of children with the flu who are not treated with the drug.
"Influenza-associated delirium and neuropsychiatric disorders are not uncommon and occur in the United States in approximately 4 of every 100,000 influenza patients," Roche said.
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