What Are Fdas Next Steps?
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 from the Advisory Committee members. FDA anticipates it will continue to monitor the adverse event profile, including neuropsychiatric adverse events, in all ages including pediatric patients, and will report back to the Pediatric Advisory Committee within 2 years. Through these activities we expect to further refine our understanding of the adverse event profile of Tamiflu. As we did last flu season, we will continue to collaborate with the Centers for Disease Control and Prevention to share information regarding influenza surveillance in the U.S. population and the use of antivirals, including Tamiflu, for treatment.
Other Tamiflu Pediatric Adverse Events: Questions and Answers FAQs
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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 …
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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 …
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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 …
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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 …
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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 …
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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 …
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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 …
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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 …
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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 …
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Q:
What Should I Do About This Information?
A: If you or your child is receiving Tamflu for the treatment of influenza and you are concerned that you may be experiencing a drugrelated adverse event, you should …
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