USE OF COLCHICINE IN PREGNANCY

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(Date of issue: September 2021, Version: 1)

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

Colchicine is licensed for the treatment of acute gout and prophylaxis of gout attack, but is also used off-licence for the prophylaxis of familial Mediterranean fever (FMF; recurrent polyserositis). Colchicine is a mitotic spindle fibre inhibitor which induces metaphase arrest in cells undergoing mitosis.

Data regarding exposure to colchicine during pregnancy are mainly derived from its use to treat familial Mediterranean fever (FMF) and Behçet’s disease (BD), and consist of approximately 1,000 colchicine-exposed pregnancies described in controlled studies and larger case series.

The available data do not provide evidence of an increased risk of congenital malformation, miscarriage or stillbirth. One of two studies investigating karyotype anomaly described a 2.2-fold increased risk in abnormal fetal karyotype in infants exposed to colchicine during pregnancy (combined maternal and paternal exposures) compared to unexposed controls. However, the authors emphasised that the absolute risk of fetal aneuploidy was low in the colchicine-exposed group (0.66% vs. 0.15% in the control group). No adjustment for co-variable risk factors, other than maternal age, was performed, therefore data confounding cannot be excluded. Additionally, maternal and paternal exposures were not analysed separately, so it is difficult to determine whether maternal exposure during early pregnancy/pre-conception is a risk (in contrast to paternal exposure). Another three studies investigating karyotype anomaly rates (one also combined maternal and paternal exposures, two investigated maternal exposure only) did not identify an association. The evidence for an increased risk of karyotype anomaly following maternal and/or paternal exposure is unclear.

Data regarding the risk of low birth weight (LBW)/small for gestational age (SGA) infants and preterm delivery following colchicine exposure in pregnancy are limited and conflicting. However, FMF and BD are both independent risk factors for these outcomes, therefore confounding by indication is possible. Further studies controlling for indication are required. There are no data on which to assess the risk of neonatal complications or neurodevelopmental impairment.

Exposure to colchicine at any stage in pregnancy would not usually be regarded as medical grounds for termination of pregnancy. However, 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.