Tamiflu Pediatric Adverse Events: Questions and Answers FAQs

• Q: Why Are Certain Drugs Having Their Safety Reports Presented To The Pediatric Advisory Committee On November 18, 2005?
  A: The eight products being reviewed are presently due for a public discussion of their adverse events as required by Section 17 of the Best Pharmaceuticals for Children … More
• Q: What Are The Drugs Being Presented On November 18, 2005?
  A: The following drugs, which received their marketing exclusivity at least one year prior to this meeting, will be discussed: Anagrelide (Agrylin) Carboplatin … More
• Q: Why Is There An In-Depth Presentation On Tamiflu (Oseltamivir)? What Will The Presentation Include?
  A: The PAC will hear several presentations on oseltamivir (Tamiflu) including adverse event reports, a literature review, and analysis of the clinical trials data. In … More
• Q: What Is Tamiflu And What Is It Approved For?
  A: Tamiflu (oseltamivir phosphate) is an antiviral drug approved for treatment of uncomplicated influenza A and B in patients 1 year of age or older. It is also approved … More
• Q: Does This Discussion Have Anything To Do With The Pandemic Preparations?
  A: The Pediatric Advisory Committee discussion is not directly addressing any issues related to pandemic flu preparations. Indirectly, a better understanding of Tamiflu … More
• Q: Is Tamiflu Approved For Use In Pediatric Patients?
  A: Tamiflu is available in both capsule and liquid formulations. It is approved for treatment of influenza in children over 1 year of age. In the U.S., Tamiflu is dosed … More
• Q: What Is Useful About Tamiflu In Pediatric Patients? Who Should Use It?
  A: When used as directed (twice daily for 5 days) Tamiflu can reduce the duration of influenza symptoms in otherwise healthy children by 1 to 1 ½ days. It also … More
• Q: What Are The Important Safety Issues And Adverse Events?
  A: When Tamiflu was studied in clinical trials as treatment for children with influenza, children taking Tamiflu experienced similar side effects as children not taking … More
• Q: Why Are Many Of The Adverse Events Being Reported From Japan?
  A: Initially, it was not clear why the neuropsychiatric adverse events and deaths were reported almost entirely in Japanese children. The FDA receives adverse event … More
• Q: What Are Fdas Next Steps?
  A: The evaluation of the pediatric adverse events will be discussed in more detail at the Pediatric Advisory Committee on November 18, 2005; FDA looks forward to comments … More