Use of Topical Tazarotene for the Treatment of Acne Vulgaris in Pregnancy: A Literature Review

Abstract

A concern with the increasing use of prescription drugs during pregnancy is teratogenic risk. This risk is undetermined for most drugs approved in the United States (US) from 2000 to 2010. Acne and psoriasis are chronic diseases that typically occur during the child-bearing years, and as topical retinoids are recommended for both acne and psoriasis treatment, is it possible for women to be exposed to a topical retinoid during pregnancy. Pharmacokinetic studies show relatively low systemic exposure from topical retinoids, but the exposure levels that could lead to teratogenicity in humans are unknown. Tazarotene, a topical retinoid, was US Food and Drug Administration (FDA) approved for both acne and psoriasis using pharmacokinetic data from psoriasis studies, which estimated the data based on use of tazarotene on up to 20% body surface area. As such, under both the previous and current FDA pregnancy labeling, tazarotene is not recommended for use during pregnancy. The goal of this literature review was to provide historical context for the pregnancy labeling rule for tazarotene compared with other approved retinoids and gather available data on tazarotene- and retinoid-related pregnancy outcomes. While there are case reports of topical tretinoin and adapalene exposure in utero, it is unclear if either affected fetal development. In terms of topical tazarotene, there are currently limited data regarding pregnancy outcomes after in-utero exposure. Additional case reports and outcomes studies are needed to further explore the safety of topical tazarotene in pregnancy.

Keywords: Retinoids; labeling; pregnancy; review; tazarotene; topical.

FIGURE 1.

Pregnancy and lactation labeling changes.,

FIGURE 2.

Distribution of tazarotene-treated patients by tazarotenic acid plasma concentrations; adapted from Tang-Liu et al. Data shown for the distribution of tazarotenic acid plasma concentration (ng/mL) in 601 patients with psoriasis treated with tazarotene 0.05% and 0.1% gel once daily for up to one year. BLQ: below the limit of quantitation

FIGURE 3.

Maximum plasma concentrations^a from topical tazarotene, oral vitamin A, no treatment (endogenous levels) or oral isotretinoin.,,,, Tazarotenic acid is a metabolite of tazarotene; trans-retinoic acid is a metabolite of vitamin A. Oral isotretinoin was provided under fed conditions (high fat standardized meals). ^aData for endogenous and oral vitamin A were provided as “plasma concentrations” and did not specify mean maximum plasma concentrations. ^bStudy protocol dictated exaggerated and precise dosage condition. BSA: body surface area; NR: not reported