WASHINGTON -
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.
The Swiss pharmaceutical company warned in a letter to doctors that cases of delirium and self-injury have been reported among patients taking the prescription flu medication. The Food and Drug Administration posted the letter to its Web site Tuesday, along with the drug's updated labeling.
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, as recommended by FDA advisers at a November meeting.
At that meeting 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.
Roche (other-otc: RHHBY.PK - news - people )'s new label states that "the contribution of Tamiflu to these events has not been established." The label 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," states the Tamiflu label.
Japan accounts for two-thirds of the $2.4 billion global market for Tamiflu because doctors there usually prescribe drugs to treat flu symptoms.
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