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FDA Advisory Committee for Lotronex - PowerPoint PPT Presentation


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FDA Advisory Committee for Lotronex. Jeffrey D. Roberts, B.Sc. President & Founder Irritable Bowel Syndrome Self Help Group, Irritable Bowel Syndrome Association, Coordinator Lotronex Action Group jeffrey.roberts@ibsgroup.org http://www.ibsgroup.org. Side Effects while taking Lotronex.

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FDA Advisory Committee for Lotronex


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    Presentation Transcript
    1. FDA Advisory Committee for Lotronex Jeffrey D. Roberts, B.Sc. President & Founder Irritable Bowel Syndrome Self Help Group, Irritable Bowel Syndrome Association, Coordinator Lotronex Action Group jeffrey.roberts@ibsgroup.org http://www.ibsgroup.org

    2. Side Effects while taking Lotronex Diarrhea 2% Constipation 25% Ischemic Colitis 1% Nausea 3% None 59% Abdominal Pain 6% Sleep Disturb. 1% Other 3% Patients’ Perspective References: Electronic survey conducted by the Irritable Bowel Syndrome Self Help Group December 2000 – March 2001 of 485 former and current Lotronex users.

    3. Restrictions Willing to Accept Reference: Electronic survey conducted by the Irritable Bowel Syndrome Self Help Group March 2002 – April 2002 of IBS sufferers.

    4. Risk Management • Patients sign an Informed Consent form • Patients participate in surveys about use and side effects in order to provide ongoing feedback • IBS Self Help Group and IBS Association websites1 provide Lotronex education and signs and symptoms information to users and the IBS Community Reference:1. http://www.ibsgroup.org and http://www.ibsassociation.org

    5. Conclusion • IBS sufferer’s quality of life was dramatically improved with access to Lotronex. • IBS sufferers are prepared to accept the risks associated with its use. • IBS sufferers will work with the FDA to reduce those risks.