After some arm-twisting from the FDA, Roche has added stronger warnings to its Tamiflu label. In a Dear Healthcare Professional letter, the company cautioned doctors about the sometimes-fatal psychiatric problems seen in a small number of patients. Some have gone delirious and hurt themselves, even killed themselves, by falling from windows or balconies or running into traffic.
An FDA advisory committee discussed the problems at a November meeting, where the agency revealed nearly 600 reports of psychiatric troubles in Tamiflu patients, three-fourths of them in Japan. But because the flu itself can cause delirium and hallucinations, the new Tamiflu label states that the drug hasn't been definitively linked to the behavior problems.
Now, Australian regulators say they're keeping an eye on Tamiflu. They've updated the labeling for the drug, too.