USE OF ACAMPROSATE IN PREGNANCY

Acamprosate is a synthetic amino acid neuromediator analogue that is similar in structure to taurine and gamma-amino-butyric acid (GABA), and which inhibits excitatory neurotransmission. It is licensed for use in conjunction with counselling for maintaining abstinence in alcohol-dependent patients.

Animal reproductive toxicity studies have provided evidence of fetal malformation and increased rates of stillbirth. However, these effects were only observed following administration of doses much greater than those used in human therapy.

Published human data is limited to one population-based retrospective cohort study of 54 acamprosate-exposed pregnancies.  This study does not provide evidence of an increased rate of congenital malformation, preterm delivery, low birth weight or neonatal complications following in utero acamprosate exposure. Rate of miscarriage was not studied.

Unpublished human exposure data consist of a small uncontrolled case series and reports collected prospectively by UKTIS.  These data include cases of miscarriage, congenital malformation, and adverse neurodevelopmental effects.  However, the total number of exposed pregnancies is small (n=32) and data are heavily confounded, in most cases by maternal alcohol use.  It is therefore not possible to reliably comment on the risk posed to the developing fetus following intrauterine acamprosate exposure.

While it is not currently possible to recommend the routine use of acamprosate during pregnancy, alcohol is a confirmed human teratogen, and as such, maternal acamprosate use may be considered beneficial in some cases. Where gestational acamprosate use is considered, the potential risks to the fetus should be weighed against the known risks to both mother and fetus of excessive alcohol exposure, on a case-by-case basis.

Exposure to acamprosate 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. As there are extremely limited data to predict the fetal effects of maternal acamprosate use in pregnancy, particularly following use in the first trimester, additional fetal monitoring may be warranted. Due to the limited amount of data currently available, the reporting of exposures to UKTIS is encouraged.