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31-03-2010 | Article

Safety of topical corticosteroids in pregnancy remains undecided

Abstract

Free abstract

MedWire News: The current evidence concerning the safety of topical corticosteroids in pregnancy is limited and inconclusive, say researchers.

This makes it impossible to determine whether or not maternal exposure to topical corticosteroids is associated with congenital abnormality, preterm delivery, and still birth.

“Topical corticosteroids are usually labeled ‘use in pregnancy is not recommended unless the potential benefit justifies the potential risk to the fetus,’” note Shu-Hui Wang, from Buddhist Tzu Chi General Hospital in Taiwan, and colleagues, who add that this labeling is confusing and non-informative.

The researchers therefore evaluated the available evidence concerning the safety of topical corticosteroids in pregnancy by conducting a Cochrane systematic review.

They searched 17 databases and trial registers, and contacted pharmaceutical companies, identifying seven studies, including two cohort and five case-control studies, which compared maternal exposure to topical corticosteroids between patients and controls.

The overall quality of the studies was generally low, as determined by the Newcastle-Ottawa Scale, and the data were limited, with most studies focusing on orofacial cleft.

The researchers also note that considerable clinical and logical heterogeneity among the studies made conducting a meta-analysis neither possible nor appropriate.

Nevertheless, they report in the Journal of the American Academy of Dermatology that most studies did not find significant associations of topical corticosteroid use with adverse outcomes.

One case-control study found a 1.07-fold increased risk for congenital abnormality with maternal topical corticosteroid use, compared with no exposure, whereas a cohort study found no association. Stratified analysis according to corticosteroid potency showed no increased risk for congenital abnormality in women receiving mild/moderate or potent/very potent corticosteroids compared with unexposed women.

The risks for orofacial cleft, cleft lip and/or cleft palate, and cleft palate alone were each found to be increased about 13 fold in women using topical corticosteroids during the first trimester in one case-control study, but no similar associations were found in another four case-control studies.

Of two cohort studies investigating a potential risk for low birthweight (<2500 g) with maternal use of very potent topical corticosteroids, only one found a significantly increased risk, at a relative risk of 2.84.

Other birth and fetal outcomes studied included preterm delivery, fetal death, low Apgar score, and mode of delivery, but none of these studies showed a significant association between these outcomes and topical corticosteroid use during pregnancy.

Given the lack of conclusive data on the safety of topical corticosteroid use during pregnancy, the researchers say “further cohort studies with comprehensive outcome measures, consideration of corticosteroid potency dosage and indications, and a large sample size are needed.”

MedWire (www.medwire-news.md) is an independent clinical news service provided by Current Medicine Group, a trading division of Springer Healthcare Limited. © Springer Healthcare Ltd; 2010

By Lucy Piper