Evaluation of Association Between Oral and Topical Terbinafine Use in Pregnancy and Risk of Major Malformations and Spontaneous Abortion.

JAMA Dermatology
Niklas Worm AnderssonJon Trærup Andersen

Abstract

Terbinafine is a commonly used antifungal agent, but safety data of its use in pregnancy are limited. To examine the association between oral and topical terbinafine exposure in pregnancy and the risk of major malformations and spontaneous abortion. A nationwide, registry-based cohort study was conducted in Denmark from January 1, 1997, to December 31, 2016, in a cohort of 1 650 649 pregnancies. Data analysis was performed from July 11 to October 20, 2019. Pregnancies were matched on propensity scores comparing oral terbinafine exposed vs unexposed (1:10 ratio), topical terbinafine exposed vs unexposed (1:10), and oral vs topical terbinafine exposed (1:1). Filled prescriptions for oral or topical terbinafine. Logistic regression was used to compute prevalence odds ratios for the primary outcome of major malformations and Cox proportional hazards regression was used to compute hazard ratios for the secondary outcome of spontaneous abortion. Based on a cohort of 1 650 649 pregnancies, oral terbinafine-exposed (n = 891 pregnancies; mean [SD] age, 30.4 [6] years) and topical terbinafine-exposed (n = 3174; mean [SD] age, 29.5 [5.4] years) pregnancies were identified; up to a total of 40 650 unexposed pregnancies were included for th...Continue Reading

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Citations

Sep 30, 2020·Expert Opinion on Drug Safety·Jose W Ricardo, Shari R Lipner
Jan 16, 2021·Journal of the American Academy of Dermatology·Niklas Worm AnderssonJon Trærup Andersen
Oct 24, 2020·Drug and Therapeutics Bulletin
Aug 1, 2020·Annales de dermatologie et de vénéréologie·J-L Schmutz
Jul 6, 2021·Indian Journal of Dermatology, Venereology and Leprology·Shyam B VermaResham Vasani

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