Evaluation of US Food and Drug Administration Drug Label Recommendations for Coadministration of Antivirals and Acid-Reducing Agents.

ABSTRACT: Coadministration with acid-reducing agents (ARAs), including proton pump inhibitors (PPIs), histamine H₂ -receptor antagonists (H₂ blockers), and antacids has been demonstrated to reduce antiviral exposure and efficacy. Therefore, it is essential that US Food and Drug Administration (FDA) drug labels include recommendations to manage these drug-drug interactions (DDIs). This investigation analyzed information in FDA drug labels to manage DDIs between ARAs and antivirals approved from 1998 to 2019. To ascertain clinical adoption, we assessed whether FDA label recommendations were incorporated into current antiviral clinical practice guidelines. We identified 82 label recommendations for 43 antiviral approvals. Overall, 56.1% of recommendations were deemed clinically ac

SUBMITTER: Shugg T 

PROVIDER: S-EPMC10080725 | biostudies-literature | 2022 Nov

REPOSITORIES: biostudies-literature