Indication for Chronic Idiopathic Urticaria慢性特发性荨麻疹指示的OTC（PPT86）课件.ppt

CLARITIN? (10 mg loratadine)OTC Indication for Chronic Idiopathic Urticaria Schering Corporation April 22, 2002 Background Joint Non-Prescription Drug and Pulmonary-Allergy Advisory Committees review on May 11, 2001: Loratadine (10 mg daily) is safe for OTC treatment of allergic rhinitis Objective To consider loratadine for treating episodes of chronic idiopathic urticaria (CIU) OTC following an initial physician diagnosis Agenda Overview John M. Clayton, Ph.D. Clinical Overview of Urticaria Eugene W. Monroe, M.D. Schering Studies on CIU Stephen Neumann Risk/Benefit Analysis and Conclusions John M. Clayton, Ph.D. CIU as an OTC Indication In-depth Review of CIU Indication New Studies CIU Patient Study Physician Practices Consumer Self-Recognition Label Comprehension Claritin? Worldwide Safety Review Expert Panel Review Findings CIU is generally not associated or confused with more serious conditions CIU is currently managed by consumers as a self-treated condition Physicians and consumers are comfortable with consumers’ ability to self-recognize recurring episodes of CIU Findings Consumers already self-treat with OTC sedating antihistamines Claritin? is safe for OTC treatment of CIU and provides a better risk/benefit alternative Adequate labeling can be developed for Claritin? OTC for safe and effective OTC use in CIU following an initial physician diagnosis URTICARIA (Hives) Eugene W. Monroe, M.D. Department of Dermatology, Advanced Healthcare Assistant Clinical Professor, Medical College of Wisconsin Objectives of Presentation Overview of Urticaria (Hives) Classification Diagnostic Evaluation Management Consequences of (consumer/patient) misdiagnosis? Differentiating Acute from Chronic Urticaria (Hives)  Acute Urticaria (Hives) Duration of few days to few weeks Incidence of 15-20% of population Etiology usually detect