Oral retinoids and their metabolites are associated with a significant teratogenic risk and should only be prescribed and dispensed to women under a Pregnancy Prevention Programme (PPP).
Acitretin (a metabolite of etretinate) is a second-generation oral retinoid licensed for the treatment of severe psoriasis, palmoplantar pustular 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 miscarriage, 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 advise that women should wait an interval of three years before conceiving after exposure to acitretin. If conception occurs within three years of exposure, women should be especially encouraged to attend their fetal anomaly scan (at 18-20 weeks) and focussed scans could be considered.
Other risk factors may also 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 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 NHS health care professionals who are logged in.
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.