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Sugammadex and Hormonal Contraceptives: How Many Are At Risk?
Abstract Number: SAT-51
Abstract Type: Original Research
Introduction: Sugammadex is newly approved by the US Food and Drug Administration (FDA) for rapid reversal of steroidal neuromuscular blockade, however has not been assigned a pregnancy category. Although a low side effect profile, sugammadex interacts with other steroids(1, 2). The manufacturer recommends patients on hormonal contraceptives use an additional non-hormonal contraceptive for seven days after receiving sugammadex.
Methods: Three months (10/8/2016-1/20/2017) of intraoperative sugammadex administration were retrospectively reviewed for a total of 184 patients. Patient demographic data, neuromuscular drug dosing, sugammadex dosing, train of four data, and hormonal contraceptive use were gathered from the anesthesia record. Exclusion criteria were deceased patients and those with restricted access records.
Results: Of 184 sugammadex administrations, 117 (63.5%) were to women, and 53 (28.8%) were to women between the ages of 18-59. Eleven (6.1%) were to women with hormonal contraceptives listed as home medications: 9 were on oral contraceptives, one had a hormonal intrauterine device, and one was on injections for In Vitro Fertilization. No postoperative counseling regarding contraception was noted in the anesthesia records.
The majority of the total sugammadex administrations were after rocuronium with only 11 after vecuronium. Fifty seven records indicated a train-of-four (TOF) of 0 prior to sugammadex administration, 53 with TOF of 1 and 14 with TOF of 2. Of those with TOF 0-1, 57 were dosed with sugammadex 3.5-4.5 mg/kg, (manufacturer's guideline= 4 mg/kg), 44 were underdosed, and 6 were dosed >4.5 mg/kg. For those with TOF 2-4; 39 were dosed between 1.5-2.5 mg/kg, close to the guideline of 2 mg/kg. One was underdosed and twenty four were dosed greater than 2.5 mg/kg. Only 68 patients had documented recovery of TOF to 4 after the administration of sugammadex, and many records were missing TOF documentation.
Conclusion: This retrospective review demonstrated that sugammadex was frequently given to women of childbearing age including some using hormonal contraceptives. It is imperative that these patients are counseled so they are aware of the potential reproductive sequelae. Further investigation is needed on the effect of sugammadex on infertility treatments and on breastfeeding as animal studies have shown a 1:1 milk to plasma ratio (2). We advocate for documentation of TOF prior to sugammadex and adhering to the drug dosing presented by the product label.
1. Carron M, Zarantonello F, Tellaroli P, Ori C. Efficacy and safety of sugammadex compared to neostigmine for reversal of neuromuscular blockade: a meta-analysis of randomized controlled trials. J Clin Anesth 2016;35:1-12.
2. Package insert Bridion. 2015. https://www.merck.com/product/usa/pi_circulars/b/bridion/bridion_pi.pdf . Manufactured by Patheon Manufacturing Services LLC, NC 27834. Manufactured for Merck Sharpe & Dohme