Table of Contents
CLARITINŽ (10 mg loratadine) OTC Indication for Chronic Idiopathic Urticaria
Background
Objective
Agenda
CIU as an OTC Indication
Findings
Findings
URTICARIA (Hives)
Objectives of Presentation
PPT Slide
Differentiating Acute from Chronic Urticaria (Hives)
Potential Causes of Urticaria (Hives)
Diagnosing Chronic Idiopathic Urticaria (Chronic Hives of Unknown Cause)
Management of Acute Urticaria (Hives)
Management of Chronic Idiopathic Urticaria
Treatment Algorithm for Chronic Idiopathic Urticaria
Spectrum of Urticaria Patients
Most Likely Conditions Confused or Misdiagnosed for CIU
Consequences of Misdiagnosis
Consequences of Misdiagnosis
Consequences of Misdiagnosis
Consequences of Misdiagnosis
Anaphylaxis
Anaphylaxis (cont.)
Conclusions
Chronic Idiopathic Urticaria: Key Studies Conducted By Schering-Plough
Schering Conducted Four Studies
Consumer Study Design
Consumer Study Design
Consumer Study Design
Q. In a typical year, how many episodes of chronic hives do you experience?
Frequency of Suffering
Q. Please indicate the symptoms you experience when your hives recur.
PPT Slide
Q. Thinking about when the hives appeared prior to seeing a physician, what, if anything, did you do to treat or relieve the condition?
Action at Initial Occurrence
Q. In the past year, how often have you seen a physician for this condition?
Physician Care
Q. When your chronic hives recur, please indicate what you normally do?
Typical Action Upon Recurrence
Physician Contact
Q. Now that your condition has been diagnosed by a physician, how easy is it for you to identify this condition when it reappears?
Ability to Self-Recognize CIU
Q. What would you do if you experienced other symptoms such as difficulty breathing, fever or trouble swallowing with your hives?
Presence of Serious Symptoms
Conclusions: Consumer Study
Physician Practices Study Design
Physician Practices Study Design
Q. What terminology do you typically use when explaining the initial diagnosis to your patients?
Nomenclature Used To Describe CIU
Q. After receiving a diagnosis of chronic idiopathic urticaria from a physician, how likely do you feel a sufferer is able to self-identify or recognize recurrent episodes of this condition?
Likelihood of Recognizing Recurrent Episodes
Q. Thinking of all the patients you have counseled for chronic idiopathic urticaria what percentage do you recommend keep medicine on hand in anticipation of a recurrent episode ?
Physician Encouraged Self-Management Practices
Conclusions: Physician Practices Study
Self Recognition Study
Self Recognition Study
Confirmed Self-Recognition
Conclusions: Self-Recognition Study
Label Comprehension Study
Label Comprehension Study
Label Comprehension Study
Label Comprehension Study
Label Comprehension
Label Comprehension
Conclusions: Label Comprehension Study
Conclusions: Label Comprehension Study
Risk/Benefit of ClaritinŽ OTC
ClaritinŽ Marketing History
ClaritinŽ Patient Exposure
ClaritinŽ Safety
Poison Center Data on Loratadine
ClaritinŽ OTC Examples of Labeled Indications
OTC Marketing Experience Canada and United Kingdom
ClaritinŽ Safety--Conclusion
Risk/Benefit Conclusions
ClaritinŽ OTC Consumer and Health Professional Education Program
ClaritinŽ OTC Consumer and Health Professional Education Program
Response to FDA Questions
PPT Slide
Conclusions
Advisory Committee Questions
Advisory Committee Questions
Advisory Committee Questions
BACK PANEL
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