What we need to know and do on sugammadex usage in pregnant and lactating women and those on hormonal contraceptives

Abstract

Sugammadex is a chemically modified γ-cyclodextrin that is used as a selective reversal agent for steroidal neuromuscular blockade. The use of sugammadex has greatly increased globally; however, little is known about its potential adverse effects in pregnant and lactating women or those using hormonal contraceptives. There are three important theoretical assumptions. Firstly, pregnancy-related physiological changes involve most organs and affect the pharmacokinetic profiles of medications. Considering the physiological changes in pregnant women and the pharmacokinetic properties of sugammadex, alterations in the dosage and safety profiles of sugammadex may occur during pregnancy. Secondly, very large and polarized sugammadex molecules are expected to have limited placental transfer to the fetus and excretion into breast milk. Finally, sugammadex can bind to steroidal neuromuscular blocking agents as well as other substances with similar structures, such as progesterone. As a result of using sugammadex, progesterone levels can be reduced, causing adverse effects such as early pregnancy cessation and failure of hormonal contraceptives. This narrative review aims to demonstrate the correlations between sugammadex and pregnancy, lactation, and reproductive potential based on previously published preclinical and clinical studies. This will bridge the gap between theoretical assumptions and currently unknown clinical facts. Moreover, this review highlights what anesthesia providers should be aware of and what actions to take while administering sugammadex to such patients.

Fetal Outcomes With and Without the Use of Sugammadex in Pregnant Patients Undergoing Nonobstetric Surgery: A Multicenter Retrospective Study

“…Do and Cho, 7 recently addressed three potential adverse effects of SGX in pregnant and lactating women, and in patients using hormonal contraceptives: (a) pregnancy-related physiologic changes affecting the pharmacokinetic profile of drugs and alterations in dosage and safety profile of SGX; (b) the large polarized SGX is expected to have limited placental transfer to the fetus and limited excretion in breast milk; and (c) cyclodextrins are known to form inclusion complexes with other compounds, such as progesterone, potentially reducing progesterone levels and influencing reproductive potential, such as early cessation of pregnancy and failure of hormonal contraception. Their narrative review confirmed that preterm births and miscarriages within four weeks of the administration of SGX during non-obstetric interventions, were not significantly different between patients with or without SGX exposure and no patient experienced preterm delivery or labor induced by SGX administration 7 . Awaiting further evidence, it may be acceptable to use SGX during lactation and breastfeeding, although the infants’ immature metabolism and renal function may delay SGX clearance and warrants its cautious use.…”