USE OF ACAMPROSATE IN PREGNANCY

Acamprosate is thought to modulate NMDA and GABA-A receptors to reduce alcohol cravings. It is licensed for maintaining abstinence in people who are alcohol-dependent, in conjunction with counselling.

Animal reproductive toxicity studies have provided evidence of fetal malformation following in utero acamprosate exposure but effects were inconsistent between species.

Published human data are 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Unpublished human exposure data consist of a small uncontrolled case series and reports collected prospectively by UKTIS.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 altered neurodevelopment. However, the total number of exposed pregnancies is small (n=32) and data are heavily confounded by maternal alcohol use. It is therefore not possible to accurately assess any risk posed to the fetus following acamprosate exposure.

While the routine use of acamprosate during pregnancy is not recommended due to a lack of safety data, alcohol is a confirmed human teratogen and, as such, acamprosate 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 alcohol misuse 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.