A 1 FDA Advisory Committee for Zelnorm Jeffrey D. Roberts, B.Sc. President & Founder Irritable Bowel Syndrome Self Help Group, Irritable Bowel Syndrome.

Slides:

Advertisements

Similar presentations

Diagnostic Work-up. There is no specific laboratory or imaging test to diagnose irritable bowel syndrome. Currently the diagnosis of IBS relies on meeting.

Advertisements

Recurrent Abdominal Pain In Childhood and Adolescence

CLINICAL PRESENTATION n Small bowel diarrheas –large, loose stools –periumbilical or RLQ pain n Large bowel diarrheas –frequent, small, loose stools –crampy,

Improving Standards of Care in Irritable Bowel Syndrome.

Ulcerative Colitis.

Overview of Irritable Bowel Syndrome

Colon Cancer. Description Colon cancer is cancer of the large intestine (colon), the lower part of your digestive system. Rectal cancer is cancer of the.

Dalia Munoz.  Its an inflammatory bowel disease (IBD) that causes a long- lasting inflammation in your digestive tract.

Irritable Bowel Syndrome Biol E-163 TA session 12/18/06.

1 Lotronex ® (alosetron HCl) Tablets Risk-Benefit Issues Victor F. C. Raczkowski, M.D. Director, Division of Gastrointestinal and Coagulation Drug Products.

The Impact of Stress on Our Health

Antidiarrheal Drugs. Normal bowel movement: An average, healthy person has anywhere from three bowel movements a day to three a week, depending on that.

1 Lotronex ® Presentation to GI Advisory Committee June 27, 2000 Hugo E. Gallo-Torres MD, PHD Medical Team Leader DGICDP CDER, FDA.

Irritable Bowel Syndrome 1481 Nadeem Khan March 2, 2015.

Management of Constipation in Adults Stephen Aglubat, MD May 2012.

Constipation. Different definitions of constipation have been used in clinical studies → difficulty in characterizing the problem. –< 3 stools / week.

Irritable Bowel Syndrome By: Rocco Paolino. Definition A combination of intermittent abdominal pain, constipation and/or diarrhea.

Causes of Constipation. Main Point Constipation is a SYMPTOM Constipation is not a diagnosis.

An Objective Study of Fatigue in Parkinson’s Disease Benzi Kluger M.D.

1 Ellora Islam Jodie Ly Tony Davi Sonaiya Kelley.

Prevalence of chronic constipation in general population Dr. Vicente Garrigues Gastroenterology Unit Hospital Universitario LA FE Valencia - Spain.

CI-1 Zelnorm ® (tegaserod maleate) Gastrointestinal Drugs Advisory Committee Meeting July 14, 2004 Gastrointestinal Drugs Advisory Committee Meeting July.

ADSORBENTS & LAXATIVE By Wiwik Kusumawati. OBJECTIVE At the end of this topic the students will be able to : At the end of this topic the students will.

1 1 Zelnorm ® (tegaserod maleate) Advisory Committee Presentation Gastrointestinal Drugs July 14, 2004.

Diarrhea. Defined as bowel movements which are excessive in volume, frequency, or liquidity. Frequency & consistency of fecal discharge are variable among.

Treatment Arvin M. Aningalan. Treatment Options Patient counseling and dietary alterations Diarrhea – Stool-bulking agents – Antidiarrheal Agents – Serotonin.

A 1 FDA Advisory Committee for Lotronex Jeffrey D. Roberts, B.Sc. President & Founder Irritable Bowel Syndrome Self Help Group, Irritable Bowel Syndrome.

A 2 Alosetron /26 Allen Mangel, M.D., Ph.D. International Director Gastroenterology International Product Development Leader, Alosetron Safety &

IN 1 NDA Gastrointestinal Advisory Committee Meeting Gaithersburg, Maryland June 26, 2000 Gastrointestinal Advisory Committee Meeting Gaithersburg,

Management of Constipation in Family Medicine Meera Kaur, PhD, RD, CDE Assistant Professor, Family Medicine University of Manitoba, Canada

Habit disorders Dr. Ibrahim Khasraw Lecturer in Pediatrics School of Medicine Sulaimani University of.

1 Lotronex: Clinical Trials Thomas Permutt Division of Biometrics II with David Hoberman, Ph.D. Zili Li, M.D.

Conclusions Sidney Cohen, MD Chairman, Department of Medicine Temple University School of Medicine Philadelphia, Pennsylvania Sidney Cohen, MD Chairman,

27 June 2000Victor F. C. Raczkowski, M.D.1 Benefit-Risk Reevaluation of Marketed Drugs Victor F. C. Raczkowski, M.D., M.S. Gastrointestinal Drugs Advisory.

Zelnorm ® (tegaserod) Division of Gastrointestinal and Coagulation Drug Products Division of Drug Risk Evaluation Gary Della’Zanna, D.O., M.Sc., F.A.C.O.S.

A Placebo-Controlled Trial of Prucalopride for Severe Chronic Constipation Michael Camilleri, M.D., Rene Kerstens, M.Sc., An Rykx, Ph.D., and Lieve Vandeplassche,

1. Skin And Nail Fungal Infections (Such As Athlete’s Foot Or Toenail Fungus) 2. Vaginal Infections, Urinary Tract Infections, Rectal Itching Or Vaginal.

Ulcerative colitis. This image from the colon shows edematous and inflamed mucosa indicative of severe inflammation. Although this patient has ulcerative.

Focus on Irritable Bowel Syndrome (IBS)

Volume 115, Issue 3, Pages (September 1998)

IRRITABLE BOWEL SYNDROME

ODS & STARR Procedure Brij B. Agarwal

AGA technical review on irritable bowel syndrome

Effect of alosetron on bowel urgency and global symptoms in women with severe, diarrhea-predominant irritable bowel syndrome: Analysis of two controlled.

Symptoms & Treatment of Irritable Bowel Syndrome (IBS)

Incorporating New Therapies in IBS-C

Barriers to communication

OIC and opioid adherence

Digestive Diseases & Disorders

Best Clinic For Painless Piles Treatment in Telangana.

Get best treatment for Constipation in Navi Mumbai|Healing Hands Clinic

Pathophysiology of Irritable Bowel Syndrome

Drugs for the treatment of irritable bowel syndrome (IBS)

Volume 134, Issue 7, Pages (June 2008)

שימוש בביופידבק לסיוע בטיפול בתסמונת המעי הרגיז IBS

Common Functional Gastroenterological Disorders Associated With Abdominal Pain Adil E. Bharucha, MBBS, MD, Subhankar Chakraborty, MBBS, PhD, Christopher.

Management of the irritable bowel syndrome

Prevalence, Characteristics, and Impact of Bloating Symptoms in Patients With Irritable Bowel Syndrome Yehuda Ringel, Rachel E. Williams, Linda Kalilani,

IRRITABLE BOWEL SYNDROME

FDA Advisory Committee for Lotronex

Charles D. Gerson, Mary-Joan Gerson

Volume 145, Issue 2, Pages e1 (August 2013)

Management of Constipation in Adults

Eluxadoline Demonstrates a Lack of Abuse Potential in Phase 2 and 3 Studies of Patients With Irritable Bowel Syndrome With Diarrhea Reginald V. Fant,

Volume 134, Issue 7, Pages (June 2008)

Volume 115, Issue 3, Pages (September 1998)

Effects of Different Coping Strategies on Physical and Mental Health of Patients With Irritable Bowel Syndrome Lilian Dindo, PhD Clinical Gastroenterology.

Figure 1. Changes of Clinical Symptoms Severity in patients on multi-strain probioticFlorasan-D or Placebo Ivashkin V. et al. The Effect of a Multi-strain.

OIC and opioid adherence

Barriers to communication

Presentation transcript:

A 1 FDA Advisory Committee for Zelnorm Jeffrey D. Roberts, B.Sc. President & Founder Irritable Bowel Syndrome Self Help Group, Irritable Bowel Syndrome Association, Irritable Bowel Syndrome Association, Founder Zelnorm Action Group

A 2 Prevalence of Chronic Constipation Chronic Constipation 2-28% Functional Disorders References: References: Definitions, Epidemiology, and Impact of Chronic Constipation, Nicholas J. Talley, MD, PhD, FRACP, Vol. 4 Suppl Reviews In Gastroenterological Disorders

A 3 How does a Chronic Constipated sufferer feel? UnwellUnwell AloneAlone WorriedWorried FrustratedFrustrated DesperateDesperate HelplessHelpless Poor quality of lifePoor quality of life

A 4 What are the symptoms? May not have a bowel movement for up to 21 daysMay not have a bowel movement for up to 21 days Pass hard stoolsPass hard stools Lack the ability to defecate on demandLack the ability to defecate on demand Strain at every bowel movementStrain at every bowel movement

A 5 Quality of Life with Zelnorm Better83% No Change 17% References: Electronic survey conducted by the Irritable Bowel Syndrome Self Help Group June 2004 – July 2004 of some current Zelnorm users. Patients’ Perspective

A 6 Diarrhea16% Patients’ Perspective Side Effects while taking Zelnorm References: Electronic survey conducted by the Irritable Bowel Syndrome Self Help Group June 2004 – July 2004 of some current Zelnorm users. None79% Diarrhea16% Nothing Significant 79% Rectal Bleeding 5% Ischemic Colitis 0%

A 7 Conclusion Chronic constipation sufferer’s quality of life is dramatically improved with access to Zelnorm.Chronic constipation sufferer’s quality of life is dramatically improved with access to Zelnorm. Adverse events should not deter either the pharmaceutical or the FDA from maintaining the drugs availability.Adverse events should not deter either the pharmaceutical or the FDA from maintaining the drugs availability. The medical community must be informed through an additional indication that Zelnorm is an effective treatment for chronic constipation.The medical community must be informed through an additional indication that Zelnorm is an effective treatment for chronic constipation.