EXAMINATION OF PROPOSED OTC STATUS FOR NONSEDATING ANTIHISTAMINES*

ABSTRACT

Loratadine, fexofenadine, and cetirizine are orally active H₁-receptor antagonists that do not have the sedating side effects of earlier antihistamines like chlorpheniramine. In 1998, Wellpoint Health Networks filed a citizen petition with the FDA to request the reclassification of certain marketed products containing these second generation antihistamines to over-the-counter (OTC) status in the United States. Contrary to common practice, this switch request did not originate from the manufacturers of these drugs. This remarkable departure from conventional practice related to the switch process makes this citizen switch petition unprecedented in nature. The unparalleled nature of this case raises many significant regulatory, safety, and legal issues related to the OTC switch process in the United States. This article aims to present an objective and detailed examination of the regulatory and safety issues related to this OTC switch petition.