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Second-generation antihistamines: the OTC debate
1Rose Medical Center, Denver, CO 80220, USA. sampey1@msn.com
Journal of the American Pharmaceutical Association (Washington, D.C. : 1996)
|May 25, 2001
Summary
Second-generation antihistamines (SGAs) demonstrate favorable safety profiles, meeting criteria for over-the-counter (OTC) availability. Consumers can safely self-treat allergic rhinitis with these newer, less sedating options.
Area of Science:
- Pharmacology
- Drug Safety
- Regulatory Science
Background:
- First-generation antihistamines (FGAs) are widely used OTC for allergic rhinitis but pose risks.
- FGAs are associated with central nervous system (CNS) adverse effects, increasing accident risks and impacting children's learning.
- Second-generation antihistamines (SGAs) offer improved safety profiles with fewer CNS effects.
Purpose of the Study:
- To evaluate the safety profiles of second-generation antihistamines (SGAs).
- To determine if SGAs meet Food and Drug Administration (FDA) criteria for over-the-counter (OTC) status.
Main Methods:
- A comprehensive MEDLINE literature search was conducted.
- Articles published between 1970 and 2000 were reviewed.
- Safety data and FDA regulatory criteria were analyzed.
Main Results:
- SGAs exhibit significantly fewer CNS adverse effects compared to FGAs.
- SGAs do not appear to impair learning in children or cause significant drug interactions.
- Several countries have already approved SGAs for OTC use.
Conclusions:
- The established safety and efficacy of SGAs support their switch to OTC status.
- Consumers should have access to SGAs for self-treatment of mild allergic rhinitis.
- Regulatory bodies should consider SGAs for OTC availability based on safety data.