Background: Despite the increasing prevalence of fetal alcohol spectrum disorders, very little is known about the prevalence and safety of pharmacotherapies for alcohol dependence during pregnancy.
Aims: To determine the prevalence of exposure to acamprosate in pregnancy in New South Wales (NSW), Australia, and to assess maternal and neonatal outcomes associated with the use of acamprosate during pregnancy.
Methods: Pharmaceutical dispensing data were linked with NSW perinatal records to identify pregnancies between 2003 and 2012 in which neonates were exposed to acamprosate (n=52). Exposed pregnancies were matched with two comparison groups; women with a recent history of problematic alcohol use (alcohol control group) and women from the general community (community control group). Perinatal records of identified women and their children were linked to NSW hospital, mortality and birth anomaly records to examine health events during pregnancy, labour and delivery, and infancy.
Results: Exposure to acamprosate occurred in 7.7 in every 100,000 pregnancies. Rates of hospital admissions during pregnancy and 42 days post-partum in acamprosate treated women were not significantly different to women in the community control group, but was significantly lower compared with the alcohol control group. Acamprosate-exposed neonates were not significantly different from the alcohol control group or the community control group in terms of birth weight. The incidence of congenital abnormalities were not significantly different to the two control groups.
Conclusion: The prevalence of acamprosate use in pregnancy in NSW is low. Acamprosate exposure in utero was not associated with poor maternal or neonatal health outcomes.