The Food and Drug Administration (FDA) is suggesting a revision to Tamiflu’s U.S. label that will include a warning for close supervision of all patients, especially children. This suggested label change comes after 103 reports from Japan of odd behavior mostly in children and included three deaths from falls.
The FDA wants the U.S. label to look more like that of Japan’s warning of disturbances in consciousness, abnormal behavior, delirium, hallucination, delusion and convulsions may occur. The label will warn not to stop use before seeking a doctor’s advice. Currently, the U.S. label only warns of seizures and confusion.
Tamiflu is more commonly prescribed in Japan where prescriptions are 10 times higher than the U.S. which has more than twice the population.