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.

Slides:

Advertisements

Similar presentations

Artesunate Rectal Capsules For the initial management of acute malaria in patients who cannot take medication by mouth and for whom parenteral treatment.

Advertisements

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

429 pharmaceutical care Plan Refa’a AlAjmi. Goal of therpay A goal of therapy is the desired response or endpoint that you and your patient want to achieve.

© Safeguarding public health Innovation; issues for regulators, society and industry. Overview of Conference topics Alasdair Breckenridge Medicines and.

The Cochrane Reviews of Acupuncture Doris Hubbs, MD, FACP April 26, 2013.

Overview of Irritable Bowel Syndrome

1 Risks and Benefits of Home-Use HIV Test Kits Richard Forshee, Ph.D. U.S. Food and Drug Administration Center for Biologics Evaluation and Research Office.

1 The Chemoprevention of Sporadic Colorectal Cancer Issues Surrounding a Benefit/Risk Analysis in Clinical Trials Mark Avigan MD CM Medical Officer Division.

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

1 Informative Studies of New Therapeutic Agents in Major Depression, GAD & Panic W Z Potter, M.D., PhD. Merck Research Laboratories.

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

Accutane FDA (Section Name - Saver’s Initials) 3/9/00 12:50 PM 1 Introduction Russell Ellison, MD Chief Medical Officer Vice President, Medical Affairs.

Accutane FDA (Section Name - Saver’s Initials) 3/9/00 12:50 PM 1 Introduction Russell Ellison, MD Chief Medical Officer Vice President, Medical Affairs.

Published in Circulation 2005 Percutaneous Coronary Intervention Versus Conservative Therapy in Nonacute Coronary Artery Disease: A Meta-Analysis Demosthenes.

1 ZELMAC (tegaserod) Presentation to GI Advisory Committee June 26, 2000 Raymond E. Joseph MD Medical Officer HFD-180.

First In Human Pediatric Trials and Safety Assessment for Rare and Orphan Diseases Andrew E. Mulberg, MD, FAAP Division Deputy Director OND/ODE3/DGIEP.

Postmarketing Safety Assessment of Osteonecrosis of the Jaw Pamidronate & Zoledronic Acid Division of Drug Risk Evaluation Office of Drug Safety FDA Carol.

Reproductive Health Drugs, Pregnancy Labeling Subcommittee Meeting March 28-29, 2000 Holli A. Hamilton, M.D., M.P.H. Pregnancy Labeling Team Office of.

RTI Health Solutions Research Triangle Park North Carolina, US US Manchester, UK UK 44(0) LEADING RESEARCH… MEASURES.

Joint Meeting of Anti-Infective Drugs & Drug Safety and Risk Management Advisory Committees December 14-15, 2006 Ketek  (telithromycin) Regulatory History.

Risk Management in premarketing phase Anshu Vashishtha MD PhD (in individual capacity employer : Watson Pharmaceuticals)

Concept Paper #3: Risk Assessment of Observational Data Session 1: Good Pharmacovigilance Practices Linda S. Hostelley on behalf of PhRMA.

1 ENTEREG ® (Alvimopan) Special Safety Section Marjorie Dannis, M.D. Division of Gastroenterology Products Office of Drug Evaluation III CDER, FDA The.

Raymond F. Anton, MD for The COMBINE Study Research Group

1 Lotronex Postmarketing Experience Ann Corken Mackey, R.Ph., M.P.H. Allen Brinker, M.D., M.S. Zili Li, M.D., M.P.H., formerly of ODS Office of Drug Safety.

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

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

Cardiovascular Risk and NSAIDs Arthritis Advisory Committee Meeting November 29, 2006 Sharon Hertz, M.D. Deputy Director Division of Analgesia, Anesthesia,

Sidney M. Wolfe M.D and Sherri Shubin M.D., M.P.H. Public Citizen’s Health Research Group FDA Drug Safety and Risk Management and Dermatologic and Ophthalmic.

Drug Safety and Risk Management Advisory Committee May 18-19, Overview of Drug Safety Challenges Gerald J. Dal Pan, MD, MHS Director Division of.

CHAPTER 21: The Psychology of Irritable Bowel Syndrome.

DIVISION OF REPRODUCTIVE AND UROLOGIC PRODUCTS Physician Labeling Rule Lisa Soule, M.D.

DHHS / FDA / CDRH 1 FDA Summary CardioSEAL® STARFlex™ Septal Occlusion System with Qwik Load NMT Medical P000049/S3.

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 &

History of Pediatric Labeling

Sertraline Use in Pediatric Population: A Risk Benefit Discussion Steven J. Romano, MD September 13, 2004 Steven J. Romano, MD September 13, 2004 Joint.

Chapter 71 Data Ethics. Chapter 72 Thought Question 1 Many new treatments for rapidly lethal diseases offer very little or no benefit to patients. Thus,

1 PHOTOFRIN® PDT for High-grade Dysplasia in Barrett’s Esophagus Edvardas Kaminskas, M.D. Medical Officer, CDER, ODE III, DGCDP Milton Fan, Ph.D. Statistical.

How To Design a Clinical Trial

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

July 15, Postmarketing Safety Evaluation of Approved Drugs and Risk Management Victor F. C. Raczkowski, MD, MS Director, Office of Drug Safety July.

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

Signal identification and development I.Ralph Edwards.

1 One Year Post Exclusivity Adverse Event Review: Sumatriptan Pediatric Advisory Committee Meeting November 18, 2005 Susan McCune, M.D. Medical Officer.

CV-1 Trial 709 The ISEL Study (IRESSA ® Survival Evaluation in Lung Cancer) Summary of Data as of December 16, 2004 Kevin Carroll, MSc Summary of Data.

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

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.

Value of Pharmacy Services January 31 st (A), 2011 J. Hirsch, Ph.D. SSPPS – 207 Introduction to Health Care Systems and Policy.

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

27 June 2000Victor F. C. Raczkowski, M.D.1 Risk-Management Options Victor F. C. Raczkowski, M.D., M.S. Gastrointestinal Drugs Advisory Committee 27 June.

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,

Date of download: 9/18/2016 Copyright © 2016 American Medical Association. All rights reserved. From: A Randomized Controlled Clinical Trial of the Serotonin.

Psych Therapies have long-term benefits for Irritable Bowel sufferers.

How To Design a Clinical Trial

Patient Focused Drug Development An FDA Perspective

Focus on Irritable Bowel Syndrome (IBS)

Martha Carvour, MD, PhD March 2, 2017

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

Incorporating New Therapies in IBS-C

Management of the irritable bowel syndrome

Volume 150, Issue 2, Pages e8 (February 2016)

FDA Advisory Committee for Lotronex

Charles D. Gerson, Mary-Joan Gerson

PCORI Research Priorities and Relevant Examples

Osteoarthritis – a case for personalized health care?

Volume 150, Issue 2, Pages e8 (February 2016)

Statement on Concerta and Methylphenidate for the June 30, 2005 Pediatric Advisory Committee The FDA has identified two possible safety concerns with.

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

Gregory Levin, FDA/CDER/OTS/OB/DBIII

Presentation transcript:

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 Committee 27 June 2000

Victor F. C. Raczkowski, M.D.2 FDA Presentations: Themes Benefit-Risk Evaluation of Lotronex –Potential Benefits of Lotronex –Potential Risks of Lotronex –Benefit-Risk Balance for Lotronex Risk-Management Options Assessing the Impact of Risk-Management Interventions

27 June 2000Victor F. C. Raczkowski, M.D.3 FDA Presentations Introduction and Benefit-Risk Reevaluation of Marketed Drugs –V Raczkowski, MD, MSc Lotronex and Serious Adverse Events of the GI Tract –H Gallo-Torres, MD, PhD

27 June 2000Victor F. C. Raczkowski, M.D.4 FDA Presentations Risk-Management Options –V Raczkowski, MD, MSc Medication Guides –N Ostrove, PhD

27 June 2000Victor F. C. Raczkowski, M.D.5 FDA Presentations Risk-Intervention Studies –E Rodriguez, MD, MPH Summary of Issues –V Raczkowski, MD, MSc

27 June 2000Victor F. C. Raczkowski, M.D.6 Benefits of Lotronex Lotronex is indicated for the treatment of irritable bowel syndrome (IBS) in women whose predominant bowel symptom is diarrhea The safety and effectiveness of Lotronex in men have not been established.

27 June 2000Victor F. C. Raczkowski, M.D.7 Benefits of Lotronex: Issues Limit administration of Lotronex to target population Limit administration of Lotronex to responders

27 June 2000Victor F. C. Raczkowski, M.D.8 Benefits of Lotronex: Issues If a drug is not effective in a population taking a drug, those patients experience risk without benefit If a drug is not effective in an individual taking a drug (i.e., the patient is a non- responder), that patient experiences risk without benefit

27 June 2000Victor F. C. Raczkowski, M.D.9 Limit Lotronex Administration to Target Population

27 June 2000Victor F. C. Raczkowski, M.D.10 What is the Target Population? Target population for Lotronex is women with diarrhea-predominant IBS Not indicated for women with other subtypes of IBS Example: Subgroup analyses suggest Lotronex may not be effective in women with IBS who have alternating diarrhea and constipation

27 June 2000Victor F. C. Raczkowski, M.D.11 Need for Legitimate Diagnosis of Irritable Bowel Syndrome Lotronex should be used only in women with a genuine diagnosis of diarrhea- predominant irritable bowel syndrome –Not a casual diagnosis of IBS –Not a misdiagnosis of IBS Identify specific criteria or tests needed for selection of women who might benefit from use?

27 June 2000Victor F. C. Raczkowski, M.D.12 Other Populations Not indicated for men: Data suggest Lotronex is not effective in men even at dosages eight times that used in women Not indicated for pediatric use: Lack of data

27 June 2000Victor F. C. Raczkowski, M.D.13 Limit Administration of Lotronex to Responders

27 June 2000Victor F. C. Raczkowski, M.D.14 Lotronex Responders: The Issue 40% of women with diarrhea-predominant IBS did not improve 40-50% improved spontaneously or due to other factors (e.g., placebo effect) Only in 10-20% improvement attributable to Lotronex

27 June 2000Victor F. C. Raczkowski, M.D.15 Study 3001: Diarrhea-Predominant Subgroup: Monthly Relief of IBS Pain/Discomfort: LOCF

27 June 2000Victor F. C. Raczkowski, M.D.16 Study 3002: Diarrhea-Predominant Subgroup: Monthly Relief of IBS Pain/Discomfort: LOCF

27 June 2000Victor F. C. Raczkowski, M.D.17 Responders: Conclusions Of women with diarrhea-predominant IBS who take Lotronex and improve, 68-80% improve spontaneously or due to other factors not attributable to Lotronex Many may continue to take Lotronex because of false belief that improvement is due to drug

27 June 2000Victor F. C. Raczkowski, M.D.18 Responders: Conclusions These patients are exposed, possibly chronically, to risk without benefit Terminate treatment in patients who fail to respond to Lotronex? Identify specific conditions that should be met before drug is used on a long-term basis (e.g., identify responders)?

27 June 2000Victor F. C. Raczkowski, M.D.19 Benefit: Overall Conclusions Lotronex is a palliative (not curative) treatment for IBS Lotronex has not been shown to prevent progression of IBS symptoms Proportion of women who have benefit attributable to Lotronex is modest

27 June 2000Victor F. C. Raczkowski, M.D.20 Benefit: Overall Conclusions Administration of Lotronex only to target population would help optimize benefit-risk ratio Administration of Lotronex only to true responders would help optimize benefit-risk ratio