Clarinex carcinogenesis, mutagenesis, impairment of fertility precautions
The carcinogenic potential of Clarinex was assessed using a loratadine study in rats and a Clarinex study in mice. In a 2-year study in rats, loratadine was administered in the diet at doses up to 25 mg/kg/day (estimated Clarinex and Clarinex metabolite exposures were approximately 30 times the AUC in humans at the recommended daily oral dose). A significantly higher incidence of hepatocellular tumors (combined adenomas and carcinomas) was observed in males given 10 mg/kg/day of loratadine and in males and females given 25 mg/kg/day of loratadine. The estimated Clarinex and Clarinex metabolite exposures in rats given 10 mg/kg of loratadine were approximately 7 times the AUC in humans at the recommended daily oral dose. The clinical significance of these findings during long-term use of Clarinex is not known.
In a 2-year dietary study in mice, males and females given up to 16 mg/kg/day and 32 mg/kg/day Clarinex, respectively, did not show significant increases in the incidence of any tumors. The estimated Clarinex and metabolite exposures in mice at these doses were 12 and 27 times, respectively, the AUC in humans at the recommended daily oral dose.
In genotoxicity studies with Clarinex, there was no evidence of genotoxic potential in a reverse mutation assay (Salmonella/E. coli mammalian microsome bacterial mutagenicity assay) or in two assays for chromosomal aberrations (human peripheral blood lymphocyte clastogenicity assay and mouse bone marrow micronucleus assay).
There was no effect on female fertility in rats at Clarinex doses up to 24 mg/kg/day (estimated Clarinex and Clarinex metabolite exposures were approximately 130 times the AUC in humans at the recommended daily oral dose). A male specific decrease in fertility, demonstrated by reduced female conception rates, decreased sperm numbers and motility, and histopathologic testicular changes, occurred at an oral Clarinex dose of 12 mg/kg in rats (estimated Clarinex exposures were approximately 45 times the AUC in humans at the recommended daily oral dose). Clarinex had no effect on fertility in rats at an oral dose of 3 mg/kg/day (estimated Clarinex and Clarinex metabolite exposures were approximately 8 times the AUC in humans at the recommended daily oral dose).
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