Under pressure from regulators, drug maker Roche has added stronger language to its Tamiflu label, warning of sometimes fatal psychiatric problems seen in a small number of patients, theAssociated Press reports.
The drugmaker warned in a letter to docs that cases of delirium and self-injury have been reported among patients taking the prescription flu med. The older label mentioned reports of psychiatric problems, primarily seen among children in Japan. But the new label specifies that those problems sometimes proved to be fatal, which was recommended by an FDA panel at an advisory committee meeting last November. UPDATE: Glaxo also sent a letter concerning its Relenza flu med.
At that meeting, the FDA revealed that nearly 600 cases of psychiatric problems had been reported in Tamiflu patients, with 75 percent of them coming from Japan. At least five children there died after "falling from windows or balconies or running into traffic," according to FDA.
The new labeling for both meds states that "the contribution of Tamiflu to these events has not been established," and also stresses that the flu, with or without treatment, can cause behavioral problems ranging from delirium to hallucinations. "Patients with influenza should be closely monitored for signs of abnormal behavior," the Tamiflu label states. Japan accounts for two-thirds of the $2.4 billion global market for Tamiflu, because doctors there usually prescribe drugs to treat flu symptoms, the AP reminds us.