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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
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April 22, 2002
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
To consider loratadine for treating episodes of chronic idiopathic urticaria (CIU) OTC following an initial physician diagnosis
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.
Eugene W. Monroe, M.D.
Department of Dermatology, Advanced Healthcare
Assistant Clinical Professor, Medical College of Wisconsin
Acute Urticaria (Hives)
1. Yocum, Rochester Epidemologic Study - Journ Allergy Clin Immuno 104:452-6, 1999
2. Neugut, Arch. Int. Med. Vol.161, Jan 8, 2001
3. Winbery, Lieberman, Immun Clinic North America Vol 15 no 3 Aug ‘95
Consumer Habits and Practices Study (N=388)
Understand how patients with CIU recognize and treat their symptoms
Physician Practices Study
Understand physician practices and perceptions regarding CIU among a representative sample of key specialties
Consumer Self-Recognition Study
Label Comprehension Study
Learn how well CIU patients self-recognize CIU and its symptoms and self-manage after initial physician diagnosisSchering Conducted Four Studies
Understand consumer’s ability to
comprehend certain communications
points on the draft label
Screening of Subjects
Re-screening/Validation of Subjects
US Adult (18+) Population
52Consumer Study Design
Note: Responses do not equal 100
due to multiple responses
(Question context is prior to diagnosis of CIU)
Total (N=388)Used any OTC- topical or systemic (Net) 70 %
Took an OTC antihistamine such as Benadryl or Chlor-Trimeton62 %
Used a topical anti-itch cream such as Benadryl 36 %
Used a topical anti-itch lotion such ascalamine lotion 46 %
Note: Multiple Mentions
Use prescribed medication already on hand 52%
Use OTC medication 43
Call/visit physician 20
Take bath/soothing bath/soak wash areas 3
Nothing/wait it out/no longer have problem 8
Go to emergency room 1
All other mentions 5
Note: Multiple Mentions
Subjects Who Call/Visit
Physician 20 %
When Contact Physician
Every time 4 %
Sometimes 4 %
Only when symptoms don’t respond
to current treatments/medication(s) 7 %
Only when a more serious symptom
such as swelling of face/mouth occurs 2 %
No answer 3 %Physician Contact
Ease of Recognition
Very easy 80 %
Somewhat easy 14 %
Very/Somewhat Easy94 %
Neither easy nor difficult 6 %
Somewhat difficult -
Very difficult -
Q. After receiving a diagnosis of chronic idiopathic urticaria from a physician, howlikely do you feel a sufferer is ableto self-identify or recognize recurrent episodes of this condition?
Perceived Likelihood to Identify
Recurrent Episodes: After
(N=359) Very/Somewhat Likely96 %
Very Likely 60 %
Somewhat Likely 36 %
Q. Thinking of all the patients you have counseled for chronic idiopathic urticariawhat percentage do you recommend keep medicine on hand in anticipation of a recurrent episode ?
Study Method (Cont’d)
Agreement Between Patient
Study Population (N=565)
% - Percent of General Population
Toxic Exposure Surveillance System Database 1997-2001
Australia “chronic urticaria (hives), itchy rash”
Canada “allergic skin conditions, hives”
Germany “chronic urticaria (hives) with itching”
Switzerland “chronic hives (urticaria)”
United Kingdom “allergic skin conditions, rash, itching,
and urticaria (hives)”
Based on total of 38 million patient days of exposure
contact with physician
Potential Delivery Platforms
Health Professional Support
Ask a doctor before use if you have never had migraines diagnosed by a health professional
1. Is urticaria a disease process appropriate for an OTC indication?
If yes, should the indication be for chronic idiopathic urticaria (CIU)/hives or should it be broader such that it includes acute urticaria/hives?
2. If your answer to Question 1 is “yes,” are there sufficient data to support an OTC switch of loratadine for CIU or a more general urticaria claim.
If not, what other types of data are needed (such as clinical trial(s) for efficacy, safety label comprehension, or actual use)?
3. If your answer to Question 2 is “yes,” what are your recommendations for appropriate labeling of loratadine, with regard to indications, warnings, and directions.
Claritin® is an appropriate, safe and effective therapy for treating symptoms of previously diagnosed chronic idiopathic urticaria in an OTC setting.