Second-generation antihistamines: the OTC debate

To demonstrate that the safety profiles of second-generation antihistamines (SGAs) meet the criteria set by the Food and Drug Administration (FDA) for switching these products to over-the-counter (OTC) status.

MEDLINE search of articles published from 1970 through 2000.

Most patients with allergic rhinitis treat their symptoms with first-generation antihistamines (FGAs), which are available over-the-counter (OTC). Yet FGAs are generally considered less safe than the newer drugs. FGAs cause central nervous system (CNS) adverse effects and may increase users' risk for work-related injuries and motor vehicle accidents and, in children, for learning impairment. SGAs cause fewer CNS effects, do not appear to affect learning in children, and do not have significant drug interactions. Several other countries have made SGAs available OTC. Blue Cross of California petitioned FDA in July 1998 to make this class of drugs available OTC in the United States. This petition will finally be heard in May 2001. The 1951 Durham-Humphrey amendment to the original Federal Food, Drug and Cosmetic Act of 1938 requires that "a drug be made available without a prescription if, by following the labeling, consumers can use it safely and effectively without professional guidance." If judged according to this and other criteria promulgated by FDA, SGAs should be strongly considered for being switched to OTC status.

The safety and efficacy of SGAs have been adequately established. Consumers should have the option of self-treating mild allergic rhinitis symptoms with these products.