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Date of issue: September 2021, Version: 1

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 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.

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