FDA adds ‘[tag]abnormal behavior[/tag]’ warning for Tamiflu label
WASHINGTON (AP) — Patients who take [tag]Tamiflu[/tag] should be closely monitored for signs of abnormal behavior, [tag]health[/tag] officials said Monday in announcing an updated label for the [tag]flu[/tag] drug.
The added precaution comes after reports of more than 100 new cases of [tag]delirium[/tag], [tag]hallucinations[/tag] and other unusual [tag]psychiatric behavior[/tag] in children treated with the drug. Most were Japanese children.
The [tag]Food and Drug Administration[/tag] said a relationship between the drug and the behavior had not been established and that the updated label was “intended to mitigate a potential risk associated with Tamiflu.” It recommends that close monitoring begin immediately after starting treatment with the drug.
[tag]FDA[/tag] said it had received 103 reports, mostly from Japan, of injury and delirium among the millions of flu patients treated with Tamiflu. The changes bring the U.S. label more in line with the Japanese one, which already warned such abnormal behavior could occur. The previous FDA-approved label mentioned “seizure and confusion” seen in some patients.
Tamiflu is made by the Swiss [tag]pharmaceutical[/tag] company [tag]Roche[/tag] Holding AG. Roche spokesman Terence Hurley said there was no evidence the drug caused the rarely occurring adverse events.
http://www.cnn.com/2006/HEALTH/11/13/tamiflu.behavior.ap/index.html