Evidence-based (S3) Guideline on Topical Corticosteroids in Pregnancy

C.-C. Chi; G. Kirtschig; W. Aberer; J.-P. Gabbud; J. Lipozencić; S. Kárpáti; U.-F. Haustein; T. Zuberbier; F. Wojnarowska

Disclosures

The British Journal of Dermatology. 2011;165(5):943-952. 

In This Article

Abstract and Introduction

Abstract

Women with skin conditions may need topical corticosteroids during pregnancy. However, little is known about the effects of topical corticosteroids on the fetus. A guideline subcommittee of the European Dermatology Forum was organized to develop an evidence-based guideline on the use of topical corticosteroids in pregnancy (https://www.euroderm.org/edf/images/stories/guidelines/EDF-Guideline-on-Steroids-in-Pregnancy.pdf). The evidence from a Cochrane Review suggested that the major possible adverse effects on the fetus of topical corticosteroids were orofacial clefts when used preconceptionally and in the first trimester of pregnancy, and fetal growth restriction when very potent topical corticosteroids were used during pregnancy. To obtain robust evidence, a large population-based cohort study (on 84 133 pregnant women from the U.K. General Practice Research Database) was performed, which found a significant association of fetal growth restriction with maternal exposure to potent/very potent topical corticosteroids, but not with mild/moderate topical corticosteroids. No associations of maternal exposure to topical corticosteroids of any potency with orofacial cleft, preterm delivery and fetal death were found. Moreover, another recent Danish cohort study did not support a causal association between topical corticosteroid and orofacial cleft. The current best evidence suggests that mild/moderate topical corticosteroids are preferred to potent/very potent ones in pregnancy, because of the associated risk of fetal growth restriction with the latter.

Introduction

Topical corticosteroids are the principal therapy for eczematous dermatoses[1] and are also effective in treating inflammatory dermatoses such as discoid lupus erythematosus,[2] bullous pemphigoid[3] and chronic palmoplantar pustulosis.[4] Women with these chronic inflammatory dermatoses may continue to need topical corticosteroids during pregnancy. Moreover, women with specific dermatoses of pregnancy, e.g. polymorphic eruption of pregnancy, pemphigoid gestationis and atopic eruption of pregnancy, also require topical corticosteroid treatment.[5] However, little is known about the effects of topical corticosteroids on the fetus. Pharmacology references such as the British National Formulary do not give specific advice on prescribing topical corticosteroids in pregnancy. Topical corticosteroids are often labelled in the prescribing information only as: 'should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus'.

This lack of knowledge may have a negative impact on the wellbeing of the mother and fetus. Treatment decisions are almost always a trade-off between potential benefits and harms. Lack of information and clarity regarding the risk of topical corticosteroids leads to physicians' uncertainty and often results in nonprescribing, and causes pregnant women excessive concerns of possible fetal harm, followed by weakened adherence to the regimen and compromised therapeutic effectiveness. A survey of 250 heads of dermatology departments throughout Europe showed that 30% had concerns about the prescribing of topical corticosteroids in pregnancy and 91% limited their prescribing.[6]

On the other hand, there may be overprescribing of topical corticosteroids with adverse effects on the fetus. A general assumption is that low-potency topical corticosteroids, like hydrocortisone acetate, are safe to be used during pregnancy; however, this might be wrong. Despite the lack of sufficient safety information, many women still use topical corticosteroids during pregnancy; and surveys from Australia, Denmark, Finland, the Netherlands, U.K. and U.S. showed usage of topical corticosteroids by 2–8·6% of pregnant women.[6–13]

The uncertainty of the safety of topical corticosteroids in pregnancy highlights the need for an evidence-based guideline in making an informed clinical decision. In 2008, a guideline subcommittee of the European Dermatology Forum was organized to develop an evidence-based (S3) guideline on the use of topical corticosteroids in pregnancy. An S3 guideline is based on a consensus derived from a systematic search of the literature with critical appraisal of evidence levels and a systematic decision process.[14] Two workshop meetings were held to establish a consensus for the development and implementation of the guideline. At the first meeting it was established that no 'best practices' from national groups existed.

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