FDA Advisory Committee for Lotronex

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Presentation transcript:

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 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.

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

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

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.