From: Titus, Sandra L
Sent: Monday, April 23, 2001 9:37 AM
To: Butler, Jennie C
Subject: FW: antihistamines OTC - Doctet for NDAC May 11



-----Original Message-----
From: JPKarpel@aol.com [mailto:JPKarpel@aol.com]
Sent: Friday, April 20, 2001 4:19 PM
To: tituss@cder.fda.gov
Subject: antihistamines OTC


Dear Ms. Tituss,

I am writing to you to express my conderns over the proposal to allow the current anti-histamines to go OTC.

As a board certified pulmonologist my concerns are as follows:

1. Many patients with allergic symptoms do not realize that their symptoms represent more serious conditions such as asthma. If they are not evaluated by a physician this diagnosis could be missed. This is potentially quite dangerous to the patient and could result in significant morbidity and mortality. 

2. Those patients who are medically under-served, such as those in the Bronx where, I practice are at the greatest risk for suffering an complicating event because of poor access to medical care. Being able to buy these drugs OTC will futher aggrevate this situation and make it even more unlikely that these patients will
seek appropriate medical care.

3. The overall cost of medical care may be increased due 
to the potential complications of missing the appropriate diagnosis of asthma and/or sinusitis.

4. In addition to asthma, sinusitis may be missed as well if patients take OTC antihistamines to cover up signifinciant symptoms.

5. Patients may overuse their antihistamines and suffer unecessary adverse effects.

6. If patients overuse sedating antihistamines, their quality of life is interfered with and this also has potential adverse effects. For example, studies have demonstrated that the ability to drive an automobile is
adversely affected by sedating antihistamines.

7. Patients may have other systemic diseases which 
allergic type symptoms may mask. These diseases are again best diagnosed by a physician who will pick-up the
unusual diagnsois that requires other treatment.

  In summary, I do not believe that it is a safe idea to allow antihistamines to go OTC. These medications are not benign and indiscriminate use of them could lead to the masking of more serious disease. Physcians should continue to prescribe antihistamines as prescription drugs for the safety of the patients.

   If I can be of any assistance in this matter, please
do not hesitate to contact me.

Jill Karpel, MD
Professor of Medicine
Albaert Einstein Colleg of Medecine




 






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