Can I take levosalbutamol (levalbuterol) while pregnant or breastfeeding?

8.1 Pregnancy Teratogenic Effects: Pregnancy Category C. There are no adequate and well-controlled studies of Levalbuterol Inhalation Solution, USP in pregnant women. Because animal reproduction studies are not always predictive of human response, Levalbuterol Inhalation Solution, USP should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. During worldwide marketing experience, various congenital anomalies, including cleft palate and limb defects, have been reported in newborns of women treated with racemic albuterol which contains the levalbuterol isomer (active drug substance of Levalbuterol Inhalation Solution, USP). However, since multiple medications were taken during some of the pregnancies and there was no consistent pattern of anomalies, it was not possible to establish a relationship between racemic albuterol use and the occurrence of these congenital anomalies.

Prescribing label, section “8.1 Pregnancy” (opening excerpt): Levalbuterol (respiratory (inhalation)), Bryant Ranch Prepack. Read the full section on DailyMed. Quoted verbatim; US labels are written for US prescribers and patients.

This quote is from the respiratory (inhalation) formulation label.

Levalbuterol is the R-enantiomer of the beta-2 adrenergic agonist, albuterol (salbutamol). Although no published data exist on the use of levalbuterol by mouth or inhaler during lactation, data from the related drug, terbutaline, indicate that very little is expected to be excreted into breastmilk.[1] The authors of several reviews and expert guidelines agree that use of inhaled bronchodilators is acceptable during breastfeeding because of the low bioavailability and maternal serum levels after use.[2-5]

“Summary of Use during Lactation”, LactMed record “Levalbuterol” (LM155), quoted verbatim. Everything LactMed reports about Levalbuterol while breastfeeding.

Nursing Mothers Plasma concentrations of levalbuterol after inhalation of therapeutic doses are very low in humans. It is not known whether levalbuterol is excreted in human milk. Because of the potential for tumorigenicity shown for racemic albuterol in animal studies and the lack of experience with the use of Levalbuterol Inhalation Solution, USP by nursing mothers, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother. Caution should be exercised when Levalbuterol Inhalation Solution, USP is administered to a nursing woman.

Prescribing label, section “Nursing Mothers”: Levalbuterol (respiratory (inhalation)), Bryant Ranch Prepack. Label on DailyMed. Quoted verbatim; US labels are written for US prescribers and patients.

This quote is from the respiratory (inhalation) formulation label.