Warning has been added to the Prescribing Information of TAMIFLU (oseltamivir phosphate)

    March 04, 2008 – The U.S Food and Drug Administration (FDA), the equivalents of the Saudi Food and Drug Authority (SFDA), announced that Roche the manufacturer of TAMIFLU(oseltamivir phosphate), an oral anti-viral drug for the treatment of uncomplicated influenza(Type A and B influenza) in patients one year and older whose flu symptoms have not lasted more than two days, has notified healthcare professionals that the Prescribing Information has been revised to add to the Precautions section information related to neuropsychiatric events associated with the use of Tamiflu, in patients with influenza. These symptoms, as described in post marketing reports mostly from Japan, include delirium and abnormal behavior leading to injury, and in some cases resulting in fatal outcomes. These events were reported primarily among pediatric patients and often had an abrupt onset and rapid resolution

General Recommendations:

    Patients with influenza should be closely monitored for signs of abnormal behavior. If neuropsychiatric symptoms occur, the risks and benefits of continuing treatment should be evaluated.

Report Adverse Drug Reactions to the Saudi FDA

The public and health professionals are encouraged to report adverse drug reactions of TAMIFLU to the National Pharmacovigilance center on the internet at: