From the Guidelines
Agomelatine is not absolutely contraindicated in pregnancy, but its use should be approached with caution due to limited safety data. The medication should be avoided during pregnancy unless the potential benefit clearly outweighs the unknown risks. Animal studies have not shown direct harmful effects on pregnancy, but human data is insufficient to establish safety 1. If a woman becomes pregnant while taking agomelatine, treatment should be carefully reconsidered, and alternatives with better established safety profiles during pregnancy (such as certain SSRIs like sertraline) should be discussed.
Key Considerations
- The decision to use agomelatine during pregnancy requires individualized risk-benefit assessment with healthcare provider involvement 1.
- Women of childbearing potential taking agomelatine should use effective contraception.
- The mechanism of concern relates to agomelatine's effects on melatonin receptors and serotonergic activity, which have unknown consequences on fetal development.
- Any woman who has taken agomelatine during pregnancy should inform her obstetrician to ensure appropriate monitoring 1.
Classification of Risk
The US Food and Drug Administration classification system categorizes drugs based on their safety during pregnancy, ranging from Category A (safest) to Category X (known danger—do not use!) 1. Agomelatine's classification is not explicitly stated in the provided evidence, but its use is generally considered to be possibly safe or of uncertain risk due to the lack of human data.
Clinical Implications
In clinical practice, the use of agomelatine during pregnancy should be carefully evaluated, considering the potential benefits and risks. Alternative treatments with established safety profiles should be preferred, and women taking agomelatine should be closely monitored if they become pregnant. Effective contraception is essential for women of childbearing potential taking agomelatine.
From the Research
Agomelatine Use in Pregnancy
- There is limited information available on the use of agomelatine during pregnancy, and it is not explicitly stated as being absolutely contraindicated in pregnancy in the provided studies 2, 3, 4, 5, 6.
- A study on agomelatine for postpartum depression and breastfeeding suggests that agomelatine may be safe for use during breastfeeding, but it does not provide direct information on its use during pregnancy 2.
- Another study discusses the safety of biologic agents during pregnancy, but it does not mention agomelatine specifically 3.
- Studies on agomelatine's efficacy and safety as an antidepressant do not provide clear guidance on its use during pregnancy 4, 5.
- A study on birth outcomes after inadvertent use of category X drugs contraindicated in pregnancy suggests that the risk of adverse outcomes may be lower than perceived, but it does not specifically address agomelatine 6.
Key Findings
- Agomelatine's safety and efficacy during pregnancy are not well-established in the provided studies.
- The available information on agomelatine's use during breastfeeding suggests that it may be safe, but this does not necessarily apply to its use during pregnancy 2.
- More research is needed to determine the safety and efficacy of agomelatine during pregnancy.