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Response to FDA Approval of Zelnorm for Treatment of Irritable Bowel Syndrome

NEW SURVEY SHOWS PATIENTS WITH IRRITABLE BOWEL SYNDROME SUFFER FROM SEVERE SYMPTOMS AFFECTING ACTIVITIES OF DAILY LIVING

International Foundation for Functional Gastrointestinal Disorders Presents Results to FDA Advisory Committee

For Immediate Release

Media Contact

Audra Baade
IFFGD
414-964-1799

MILWAUKEE, WI (April 23, 2002) - Today, during the FDA Advisory Committee meeting, the International Foundation for Functional Gastrointestinal Disorders (IFFGD) released the results of its IBS in the Real World survey showing the real life impact Irritable Bowel Syndrome (IBS) has on the lives of those who suffer with the disease. Results of the survey indicated substantial reduction in the quality of life and activities of daily living for patients with IBS.

IFFGD's quantitative study includes data drawn from 350 adults of the IFFGD patient database. Results of the survey reveal that nearly half of IBS sufferers polled reported daily episodes of IBS symptoms and more than one-third rated the pain associated with IBS symptoms as extreme. Additionally, more than one-quarter of survey respondents reported missing work or school due to IBS symptoms in the past three months, illustrating the challenges these patients face everyday and further highlighting the need for safe and effective treatments.

"The findings of the IBS in the Real World survey bring to light the tremendous human impact of IBS, said Nancy Norton, President and Founder of IFFGD. "Chronic and recurring symptoms of IBS can disrupt personal and professional activities, upset emotional well-being and limit individual potential, with some respondents in the survey receiving disability due to their IBS. Since there is currently no cure for IBS, it is imperative that the best ways to manage and treat this disease are made available to patients so they can enjoy a normal, active life."

About IBS

Irritable bowel syndrome is a functional disease characterized by chronic and recurrent abdominal pain and abnormal bowel function. IBS sufferers have unusually sensitive and active nerve endings in the lining of the bowel that trigger inappropriate muscle activity, resulting in episodes of diarrhea, constipation, or both in alternation. The cause of IBS is not known, and as yet there is no known cure.

About the Survey

The survey was conducted from February 6 - March 2, 2002 with 350 patients, each of whom had previously received a diagnosis of IBS. Nearly half (47%) of IBS sufferers in the study reported daily episodes of IBS symptoms with more than one third (39%) reporting extreme or very severe pain. More than one quarter (26%) of the participants reported absenteeism from work or school due to IBS symptoms in the last three months and 5% of respondents reported being on disability due to their IBS.

IBS sufferers in the survey reported using 281 different treatments, including prescription drugs, over-the-counter (OTC) medications and herbal and dietary supplements, to control their symptoms. However, less than one-third reported satisfaction with the drugs and remedies they use to treat their symptoms. Of those taking prescription drugs, 62% report side effects, with almost half (45%) reporting the side effects as severe or moderate, thus illustrating the need for more effective treatments. Of those respondents reporting side effects:

The survey results reveal the often hidden real world of IBS patients. More information about the survey is available online at www.iffgd.org/Research/IBS2002Survey.html or by calling their toll-free hotline at 1-888-964-2001.

The IFFGD is a nonprofit education and research organization whose mission it is to inform, assist and support those affected by gastrointestinal disorders. With an international group of experts from multiple disciplines who serve on the organization's medical advisory board, the IFFGD is a resource for anyone seeking current information about gastrointestinal disorders for both adults and children.

  • 12% had to visit an ER
  • 7% were hospitalized
  • 29% had to call their health care provider, and
  • 24% had to visit their health care provider
  • 22% had to stop driving
  • 18% reported missing work or school

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Last modified on February 29, 2008 at 10:50:04 AM