From the Research
Agomelatine is not recommended during pregnancy due to insufficient safety data. While it is not absolutely contraindicated, healthcare providers generally avoid prescribing agomelatine to pregnant women because there are limited human studies evaluating its safety in pregnancy. The most recent and highest quality study on the topic of antidepressants during pregnancy is from 2023 1, which provides a systematic review of meta-analyses assessing the benefits and risks of antidepressant drug use during pregnancy. Although this study does not specifically focus on agomelatine, it highlights the importance of considering the safety profiles of various antidepressants during pregnancy.
Key Considerations
- Animal studies have not shown direct harmful effects on pregnancy, but the lack of adequate human data makes agomelatine a higher-risk choice compared to better-studied antidepressants.
- If antidepressant treatment is necessary during pregnancy, medications with more established safety profiles such as certain SSRIs (like sertraline or citalopram) are typically preferred.
- The concern with agomelatine stems from its mechanism as a melatonin receptor agonist and serotonin antagonist, with unknown effects on fetal development.
- A study from 2021 2 discusses the use of agomelatine in a breastfeeding woman with postpartum depression, suggesting its safety in breastfeeding, but this does not directly address its safety during pregnancy.
Clinical Implications
- Any woman who becomes pregnant while taking agomelatine should consult her healthcare provider immediately to discuss the risks and benefits of continuing treatment versus switching to an alternative medication with better-established safety data in pregnancy.
- The decision to use agomelatine during pregnancy should be made on a case-by-case basis, considering the severity of the depression and the potential risks and benefits of treatment.
- Healthcare providers should be aware of the latest evidence and guidelines when making decisions about antidepressant use during pregnancy.