Carbinoxamine shares the actions and uses of other antihistamines.
Regulations Governing Carbinoxamine-containing Preparations
Carbinoxamine maleate was initially introduced to the US market in the early 1950s under the Federal Food, Drug, and Cosmetic Act of 1938, which required that new drugs be proven safe for use. After 1962, when Congress amended the Act to require that new drugs be proven effective (as well as safe), carbinoxamine maleate was subject to the Drug Efficacy Study Implementation (DESI) review process and subsequently, in 1973, found to be effective for nasal allergies and other allergic conditions. To legally market carbinoxamine maleate preparations, McNeil Laboratories submitted new drug applications (NDAs) for carbinoxamine maleate oral solution and tablets; however, these NDAs were later withdrawn (in 1985 and 1994, respectively) at the request of the manufacturer because the preparations were no longer marketed. As of June 2006, only one manufacturer (Mikart) had approved abbreviated new drug applications (ANDAs) for carbinoxamine maleate tablets (4 mg) and oral solution (4 mg/5 mL).
Although Mikart preparations were the only carbinoxamine-containing preparations with approved applications as of June 2006, numerous unapproved carbinoxamine-containing preparations (single-entity or fixed-combination preparations) remained on the US market. Many of these unapproved preparations contained inappropriate labeling that promoted unapproved uses (including management of congestion, cough, or the common cold, and use in children younger than 2 years of age), which may pose serious health risks. Since 1983, there have been 21 reported deaths in children younger than 2 years of age receiving carbinoxamine-containing preparations. Although a causal relationship to carbinoxamine has not been established, some data indicate that infants and young children may be more susceptible to drug-related adverse effects, partly due to the normal immaturity of their metabolic pathways. Furthermore, parents or caregivers of infants or young children receiving carbinoxamine-containing preparations may have difficulty identifying potentially serious or life-threatening adverse events associated with the drug.
Because of the potentially serious health risks associated with use of unapproved carbinoxamine-containing preparations, and because approved carbinoxamine maleate preparations were available on the US market (i.e., tablets and oral solution manufactured by Mikart), FDA announced on June 8, 2006 that it would take enforcement action (e.g., seizure, injunction, other judicial proceeding) against all firms attempting to manufacture carbinoxamine-containing preparations after September 7, 2006 without an approved application. Manufacturers who wished to continue marketing preparations containing carbinoxamine were required to submit an ANDA for such preparations. Following this announcement, several other manufacturers submitted ANDAs and received marketing approval for carbinoxamine maleate preparations.