New OTC Drugs and Devices 2001: A Selective Review

Newton GD, Benninghoff AJ, Pray WS, et al.

This annual review focuses on the debate over the proposed switch of common allergy drugs from prescription to nonprescription status, herbal remedies, and new over-the-counter (OTC) products and diagnostic tools of which pharmacists need to be aware. Non-Sedating Second-Generation Antihistamines In an unusual move, an insurance company has recommended that the prescription non-sedating antihistamines (i.e., Claritin, Allegra, and Zyrtec) be recategorized as nonprescription products. Blue Cross of California claims that patients are able to self-treat these conditions and advocates making these products OTC to improve their affordability. However, drug manufacturers, with the support of the American Academy of Asthma, Allergy, and Immunology, point out that allergies are complex and require long-term management, not episodic symptom treatment. Additionally, drug manufacturers assert that many consumers will still be unable to afford these products, making this a cost-shifting maneuver. The May 11, 2001, recommendation of the Food and Drug Administration (FDA) Nonprescription Drugs Advisory Panel was to switch second-generation antihistamines to nonprescription status. Presently, research is continuing on the issue. Herbal Remedies Another issue of concern for pharmacists is the growing use of herbal remedies. While pharmacists are charged with the task of educating consumers about the potential risks of these products, their task is made more difficult because so few adverse events associated with supplements are reported to the FDA. In addition, patients are misguided about the fact that supplements behave as traditional drugs, they often fail to report supplement use to their physicians, and they mistakenly believe that these products are more stringently monitored by a regulatory agency. Pharmacists must guide consumers in their usage of these products, assist them in separating fact from fiction, and vigilantly report adverse events and drug interactions to the FDA at www.cfsan.fda.gov/~dms/supplmnt.html. New OTC Drugs and Devices In this section of the review, new available products are presented. Some products included are:

A wound dressing that forms a gel and assists in stopping bleeding twice as rapidly as regular gauze pads
An antacid chewing gum that's noted for its convenience and ability to stimulate salvia production, which is also beneficial in alleviating indigestion
An early result pregnancy test that can be used before a missed period
A cold sore product that is designed as a patch and thus is unique in its ability to deliver anesthetic ingredients directly to the site

For other products and the full text of the article, visit http://www.aphanet.org/. J Am Pharm Assoc 2002;42:267-77 Return to Top