Tamiflu to Add Warning on Psychiatric Risks

By | November 13, 2006

Tamiflu to Add Warning on Psychiatric Risks

Tamiflu flu treatment must carry information warning of potential risks of psychiatric side effects, U.S. regulators said. The Food and Drug Administration approved a labeling revision to include information on those risks after reports of self-injury and mutilation among Japanese patients using the drug, the agency said today in an e-mailed statement. Most of these side effects were reported in children.The new label will urge doctors to monitor patients with influenza for signs of abnormal behavior immediately after they begin taking Tamiflu. While the “relative contribution of the drug to these events is not known,” the regulators said the labeling revision is intended to mitigate the potential risks. – bloom

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