Terbinafina en embarazo

Published in Dermatology

Journal Scan / Research · March 17, 2020

Oral and Topical Terbinafine Use in Pregnancy and Risk of Major Malformations and Spontaneous Abortion

JAMA Dermatology

TAKE-HOME MESSAGE

• Data from 1997 to 2016 from the Danish Medical Birth Registry and National Patient Registry were analyzed for this cohort study. Rates of major birth malformations were similar between pregnancies exposed to oral terbinafine (3.8%) vs matched unexposed pregnancies (3.8%) as well as between those exposed to topical terbinafine (3.6%) and matched unexposed pregnancies (3.3%). Findings were similar when comparing spontaneous abortion rates between oral terbinafine exposed pregnancies (10.4%) with matched controls (10.3%) and topical terbinafine exposed pregnancies (5.2%) with matched controls (5.1%).

• Current guidelines state that only topical terbinafine can be used safely during pregnancy. This study suggests that oral terbinafine during pregnancy is not associated with an increased risk of major birth malformations or spontaneous abortion.

– Caitlyn T. Reed MD

Abstract

IMPORTANCE

Terbinafine is a commonly used antifungal agent, but safety data of its use in pregnancy are limited.

OBJECTIVE

To examine the association between oral and topical terbinafine exposure in pregnancy and the risk of major malformations and spontaneous abortion.

DESIGN, SETTING, AND PARTICIPANTS

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).

EXPOSURES

Filled prescriptions for oral or topical terbinafine.

MAIN OUTCOMES AND MEASURES

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.

RESULTS

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 the matched outcome analyses. In propensity-matched comparisons of the risk of major malformations, the prevalence odds ratios were 1.01 (95% CI, 0.63-1.62) for oral terbinafine-exposed vs unexposed pregnancies (absolute risk difference [ARD], 0.04%; 95% CI, -1.69% to 1.76%), 1.08 (95% CI, 0.81-1.44) for topical terbinafine-exposed vs unexposed pregnancies (ARD, 0.26%; 95% CI, -0.73% to 1.26%), and 1.18 (95% CI, 0.61-2.29) for oral vs topical terbinafine-exposed pregnancies (ARD, 0.59%; 95% CI, -1.71% to 2.88%). For the risk of spontaneous abortion, the hazard ratios were 1.06 (95% CI, 0.86-1.32) for oral terbinafine-exposed vs unexposed pregnancies (ARD, 0.13%; 95% CI, -1.97% to 2.24%), 1.04 (95% CI, 0.88-1.21) for topical terbinafine-exposed vs unexposed pregnancies (ARD, 0.17%; 95% CI, -0.64% to 0.98%), and 1.19 (95% CI, 0.84-1.70) for oral vs topical terbinafine-exposed (ARD, 1.13%; 95% CI, -2.23% to 4.50%) pregnancies.

CONCLUSIONS AND RELEVANCE

Among pregnancies exposed to oral or topical terbinafine, no increased risk of major malformations or spontaneous abortion was identified

JAMA Dermatology

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

JAMA Dermatol 2020 Mar 04;[EPub Ahead of Print], NW Andersson, SF Thomsen, JT Andersen 

Sent from my iPhone

Benjamin Hidalgo-Matlock
Skin Care Physicians of Costa Rica

Clinica Victoria en San Pedro: 4000-1054
Momentum Escazu: 2101-9574

Please excuse the shortness of this message, as it has been sent from
a mobile device.