A CASE OF BV DURING PREGNANCY: BEST MANAGEMENT APPROACH
CALLIE FOX REEDER, MD, AND PATRICK DUFF, MD (ID CONSULT; FEBRUARY 2021)
Secnidazole for treatment of BV
The article by Drs. Reeder and Duff incorrectly states that there are no single-dose therapeutic options for bacterial vaginosis (BV) in the United States. Secnidazole 2 g single oral dose was approved by the US Food and Drug Administration (FDA) in 2017, and it is now included in the American College of Obstetricians and Gynecologists' (ACOG) clinical management guidelines for the treatment of BV in nonpregnant patients.
Secnidazole is not contraindicated in pregnancy. In a poster presented at the 2020 ACOG annual clinical meeting, we summarized results of the preclinical studies that were part of the FDA submission.1 There was no evidence of secnidazole toxicity in fertility and pre- and postnatal reproductive toxicology studies. In addition, there were no adverse developmental outcomes when secnidazole was administered orally to pregnant rats and rabbits during organogenesis at doses up to 4 times the clinical dose. These findings are consistent with the observation that no other preclinical studies, or experience from postmarketing use of secnidazole for approved indications, have suggested a risk of adverse effects when using secnidazole in pregnancy.
Steven E. Chavoustie, MD
North Miami, Florida
Reference
1. Pentikis H, Eder S, Kaufman G, Chavoustie S. Secnidazole, an approved single dose drug for bacterial vaginosis, does not cause reproductive toxicity in animals [16A]. Obstet Gynecol. 2020;135:12S.
Drs. Reeder and Duff respond
We are very appreciative of Dr. Chavoustie's interest in our article and for his thoughtful assessment of the role of single-dose secnidazole for the treatment of BV. As we noted in our article, this drug has been used extensively in Europe and Asia, but there is much less published experience with the drug in the United States. We pointed out the excellent results reported by Hillier and colleagues with 1-g and 2-g doses of this medication.1 Dr. Chavoustie is correct in stating that there is no risk of fetal harm based on animal data at up to 4 times the recommended human dose, although the manufacturer recommends discontinuing breastfeeding during, and for 96 hours after, treatment. According to www.goodrx.com, the cost of a single 2-g dose of secnidazole is $325; the cost of a 7-day course of metronidazole is approximately $16.
Reference
1. Hillier SL, Nyirjesy P, Waldbaum AS, et al. Secnidazole treatment of bacterial vaginosis: a randomized controlled trial. Obstet Gynecol. 2017;130:379-386.
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