From: Titus, Sandra L
Sent: Monday, April 23, 2001 9:38 AM
To: Butler, Jennie C
Subject: FW: Claritin Docket May 11


-----Original Message-----
From: IFinegold@aol.com [mailto:IFinegold@aol.com]
Sent: Saturday, April 21, 2001 9:44 PM
To: tituss@cder.fda.gov
Subject: Claritin


Sandra Titus 
CDER 
FDA 


Dear Ms. Titus: 

I am sending you this letter as a response to the contemplated change from 
prescription drug to over the counter status for Claritin. 

I am a physician and Board Certified in Allergy and Immunology. I have 
practiced allergy for over 30 years. I am currently Chief of the Division of 
Allergy at St. Luke's-Roosevelt Hospital in New York City and a Past 
President of the American College of Allergy, Asthma and Immunology.   

I am opposed to making the switch from prescription to O-T-C status for 
Claritin for the following reasons: 
1) while allergic disease is very prevalent in the population, 
self-medication with antihistamines will lead to inappropriate therapy for 
those patients with non allergic conditions such as common colds, or non 
allergic rhinitis 
2) self medication will either delay or eliminate the physician's role in 
taking a full history and performing an appropriate physical examination in 
order to make the correct diagnosis 
3)self medication for allergic diseases will delay appropriate allergic 
therapy such as removing pets and delay or eliminate more effective therapy 
4) some allergic diseases such as asthma may be fatal, and inadequate 
treatment with antihistamines may delay appropriate diagnosis and treatment 
and thereby add to the morbidity and mortality of that disease 


Yours truly, 

Ira Finegold, MD