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Benefit-Risk Reevaluation of Marketed Drugs. Victor F. C. Raczkowski, M.D., M.S. Gastrointestinal Drugs Advisory Committee 27 June 2000. FDA Presentations: Themes. Benefit-Risk Evaluation of Lotronex Potential Benefits of Lotronex Potential Risks of Lotronex

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benefit risk reevaluation of marketed drugs

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.

fda presentations themes
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

Victor F. C. Raczkowski, M.D.

fda presentations
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

Victor F. C. Raczkowski, M.D.

fda presentations4
FDA Presentations
  • Risk-Management Options
    • V Raczkowski, MD, MSc
  • Medication Guides
    • N Ostrove, PhD

Victor F. C. Raczkowski, M.D.

fda presentations5
FDA Presentations
  • Risk-Intervention Studies
    • E Rodriguez, MD, MPH
  • Summary of Issues
    • V Raczkowski, MD, MSc

Victor F. C. Raczkowski, M.D.

benefits of lotronex
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.

Victor F. C. Raczkowski, M.D.

benefits of lotronex issues
Benefits of Lotronex: Issues
  • Limit administration of Lotronex to target population
  • Limit administration of Lotronex to responders

Victor F. C. Raczkowski, M.D.

benefits of lotronex issues8
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

Victor F. C. Raczkowski, M.D.

what is the target population
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

Victor F. C. Raczkowski, M.D.

need for legitimate diagnosis of irritable bowel syndrome
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?

Victor F. C. Raczkowski, M.D.

other populations
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

Victor F. C. Raczkowski, M.D.

lotronex responders the issue
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

Victor F. C. Raczkowski, M.D.

study 3001 diarrhea predominant subgroup monthly relief of ibs pain discomfort locf
Study 3001: Diarrhea-Predominant Subgroup:Monthly Relief of IBS Pain/Discomfort: LOCF

Victor F. C. Raczkowski, M.D.

study 3002 diarrhea predominant subgroup monthly relief of ibs pain discomfort locf
Study 3002: Diarrhea-Predominant Subgroup:Monthly Relief of IBS Pain/Discomfort: LOCF

Victor F. C. Raczkowski, M.D.

responders conclusions
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

Victor F. C. Raczkowski, M.D.

responders conclusions18
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)?

Victor F. C. Raczkowski, M.D.

benefit overall conclusions
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

Victor F. C. Raczkowski, M.D.

benefit overall conclusions20
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

Victor F. C. Raczkowski, M.D.