Benzonatate Use in Pregnancy

Introduction to Benzonatate Classification

• The American Heart Association, as published in Circulation, notes that benzonatate is distinctly different from Category X drugs, which are explicitly contraindicated in pregnancy due to documented fetal abnormalities 1

Clinical Considerations for Benzonatate

• When considering benzonatate use in pregnancy, the European Respiratory Society suggests that first trimester exposure should be avoided when possible, as this is the period of organogenesis when risk of congenital malformations is highest 2, 3
• The European Respiratory Society recommends that risk-benefit assessment must weigh maternal benefit of cough suppression versus potential unknown fetal risks, including severity of maternal symptoms and impact on quality of life, and availability of alternative treatments with better-established safety profiles 2
• The American College of Cardiology states that truly contraindicated medications in pregnancy (Category X) include ACE inhibitors and ARBs, which cause renal dysgenesis and fetal death, and warfarin, which causes embryopathy and CNS abnormalities 1, 4, 5