What Are The Drugs Being Presented On November 18, 2005?
The following drugs, which received their marketing exclusivity at least one year prior to this meeting, will be discussed:
Anagrelide (Agrylin)
Carboplatin (Paraplatin)
Fluconazole (Diflucan)
Irinotecan (Camptosar)
Oseltamivir (Tamiflu)
Rofecoxib (Vioxx)
Sodium ferric gluconate complex (Ferrlecit)
Sumatriptan (Imitrex)
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 … 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 -
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 … More
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