USE OF ACITRETIN/ETRETINATE 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

Oral retinoids and their metabolites are associated with a significant teratogenic risk and should only be prescribed and dispensed to women under the Pregnancy Prevention Program (PPP).

Acitretin (a metabolite of etretinate) is a second generation oral retinoid, licensed for the treatment of severe psoriasis, congenital ichthyosis and keratosis follicularis (Darier’s disease). Concurrent exposure to alcohol may induce reverse metabolism to etretinate, which is stored in the liver and has a much longer half-life. Effective contraception (ideally two complimentary forms) is therefore recommended for four weeks prior to commencing treatment, during and for three years after treatment with acitretin.

Multiple malformations, including facial dysmorphia, cleft palate, cardiovascular malformations, and limb and skeletal defects have been reported following in utero exposure to acitretin. The available data are, however, limited and the risk of malformation following acitretin exposure in utero remains unquantified, although experience from other retinoids suggests that it is likely to be high.

An increased risk of spontaneous abortion and impaired neurodevelopment in the absence of malformation have been observed following in utero exposure to isotretinoin and exposure to acitretin may carry similar risks.

Guidelines suggest that women should wait an interval of three years before conceiving after exposure to acitretin. If conception occurs within this period a detailed fetal anomaly scan should be considered.

Other risk factors may be present in individual cases which may independently increase the risk of adverse pregnancy outcome. Clinicians are reminded of the importance of consideration of such factors when performing case specific risk assessments.
                      
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.