Tamiflu (oseltamivir phosphate) Information

FDA approved Tamiflu (oseltamivir phosphate), an oral anti-viral drug for the treatment of uncomplicated influenza in patients one year and older whose flu symptoms have not lasted more than two days. This product is approved to treat Type A and B influenza; however, the majority of patients included in the studies were infected with type A, the most common in the U.S.  Efficacy of Tamiflu in the treatment of influenza in subjects with chronic cardiac disease and/or respiratory disease has not been established.

Tamiflu is also approved for the prevention of influenza in adults and children aged one year and older.  Efficacy of Tamiflu for the prevention of influenza has not been established in immunocompromised patients.

• MedWatch Safety Alerts:
  • Roche and FDA informed healthcare professionals of neuropsychiatric events associated with the use of Tamiflu, in patients with influenza. (Posted 3/4/2008)
  • Postmarketing reports (mostly from Japan) of self-injury and delirium with the use of Tamiflu in patients with influenza. (Posted 11/13/2006)
    • Tamiflu Information from the Pediatric Advisory Committee, November 16, 2006
  • New preclinical safety data suggest that Tamiflu is not indicated for either treatment or prophylaxis of influenza in infants less than one year of age. (Posted 1/6/2004)
    • Summary of Pediatric Studies Review
      
      
• Patient Information Sheet (updated 12/12/2006)
• FDA News: FDA Approves Tamiflu for Prevention of Influenza in Children Under Age 12 (12/23/2005)
• Tamiflu Pediatric Adverse Events: Questions and Answers (11/17/2005) See links above under MedWatch Safety Alert for updated information
• FDA Talk Paper: FDA Approves Tamiflu for Another Indication -- Prevention of Influenza (Issued: 11/20/2000)
  
  
• Tamiflu Approval, Review, and Labeling Information (from Drugs@FDA)

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Date created: October 10, 1999, Last updated: April 7, 2008

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