Annotation of U.S. Food and Drug Administration (FDA) label information
for desloratadine
Summary
Desloratadine and psuedoephidrine is used to treat nasal congestion and other symptoms of seasonal allergic rhinitis. The label does not specify any protein or gene names associated with variation in metabolism. This drug-biomarker pair was previously in the FDA's "Table of Pharmacogenomic Biomarkers in Drug Labels" but has subsequently been removed.
Annotation
The FDA-approved drug label for desloratadine and psuedoephedrine (Clarinex-D) highlighted information regarding variation in the metabolism of desloratadine. This drug-biomarker pair was previously in the FDA's "Table of Pharmacogenomic Biomarkers in Drug Labels" but has subsequently been removed.
The label mentioned that "poor metabolizers" had a decreased ability to form 3-hydroxydesloratadine and a 6-fold greater median exposure (AUC) to desloratadine. Though no overall differences in safety were observed between poor metabolizers and normal metabolizers, the label noted that an increased risk of exposure-related adverse events in poor metabolizers cannot be ruled out. However, the label did not specify any protein or gene names associated with the variation in metabolism efficacy, therefore it is unclear from the label which enzyme has these "poor metabolizers" of desloratidine.
For the complete drug label text with sections containing pharmacogenetic information highlighted, see the desloratadine and pseudoephedrine drug label.
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