USE OF ADAPALENE IN PREGNANCY

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(Date of issue: February 2017, Version: 2)

This is a UKTIS monograph for use by health care professionals. For case-specific advice please contact UKTIS on 0344 892 0909. To report an exposure please download and complete a pregnancy reporting form. Please encourage all women to complete an online reporting form.

Summary

Adapalene is a retinoid-like compound used topically for the treatment of mild to moderate acne.

There are very limited data on the use adapalene in pregnancy, therefore it is not currently possible to provide a fetal risk assessment following exposure. Systemic adapalene is teratogenic in animal models, however topical application is not believed to result in systemic absorption; therefore the risk of malformation following topical exposure is hypothesized to be low.  There is one case report of anophthalmia following exposure to topical adapalene.

An increased risk of malformation is unlikely where topical adapalene is used at therapeutic doses during pregnancy.  Other risk factors may, however, be present in individual cases which may independently increase the risk of adverse pregnancy outcomes.  Clinicians are reminded of the importance of consideration of such factors when performing case-specific risk assessments.  Due to the known teratogenicity of retinoids, enhanced fetal monitoring may be warranted in certain cases following exposure to topical adapalene in pregnancy.  Discussion with UKTIS is recommended. 
                    
This document is regularly reviewed and updated. Only use full UKTIS monographs downloaded directly from TOXBASE.org to be sure you are using the most up-to-date version. The summaries of these monographs are openly available on UKTIS.org.

This is a summary of the full UKTIS monograph for health care professionals and should not be used in isolation. The full UKTIS monograph and access to any hyperlinked related documents is available to health care professionals at www.toxbase.org.

If you have a patient with exposure to a drug or chemical and require assistance in making a patient-specific risk assessment, please telephone UKTIS on 0344 892 0909 to discuss the case with a teratology specialist.

If you would like to report a pregnancy to UKTIS please click here to download our pregnancy reporting form. Please encourage all women to complete an online reporting form.

Disclaimer: Every effort has been made to ensure that this monograph was accurate and up-to-date at the time of writing, however it cannot cover every eventuality and the information providers cannot be held responsible for any adverse outcomes of the measures recommended. The final decision regarding which treatment is used for an individual patient remains the clinical responsibility of the prescriber. This material may be freely reproduced for education and not for profit purposes within the UK National Health Service, however no linking to this website or reproduction by or for commercial organisations is permitted without the express written permission of this service. This document is regularly reviewed and updated. Only use UKTIS monographs downloaded directly from TOXBASE.org or UKTIS.org to ensure you are using the most up-to-date version.