Tamiflu label will carry new caution in U.S.
14th Nov 2006, 23:21 GMT
The influenza drug Tamiflu will now come with a new caution urging close monitoring of patients for abnormal behavior, such as delirium and self-injury, U.S. regulators said on Monday. Officials felt it was important to add the information to the Tamiflu label even though it is not certain that the drug contributed to any of the more than 100 reports of psychiatric problems, the Food and Drug Administration said. Most cases, including some reported suicides, were recorded in Japan and involved children. “Patients with influenza should be closely monitored for signs of abnormal behavior immediately after starting Tamiflu because reports of these events indicate they occurred after one-to-two doses,” an FDA statement said.
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