What are the effects of Escitalopram (Cipralex) during pregnancy?

From the Guidelines

Cipralex (escitalopram) can be used during pregnancy when the benefits outweigh the risks, but should be discussed with a healthcare provider. It's generally considered one of the safer antidepressants for pregnant women, with relatively low risk to the developing baby. The typical dose ranges from 10-20mg daily, taken consistently throughout pregnancy if needed. Women already on Cipralex who become pregnant should not stop suddenly as this can cause withdrawal symptoms and depression relapse. Some studies suggest a small increased risk of persistent pulmonary hypertension in newborns when SSRIs like Cipralex are used in late pregnancy, and mild, temporary withdrawal symptoms may occur in newborns.

The decision to use Cipralex during pregnancy should balance the mother's mental health needs against potential risks, as untreated depression itself poses risks to both mother and baby. Regular prenatal care is essential, and breastfeeding while on Cipralex is generally considered acceptable as minimal amounts pass into breast milk. According to a study published in the Journal of Child Psychology and Psychiatry and Allied Disciplines 1, the research to date should provide women considering antidepressant use during pregnancy reassurance because it suggests intrauterine antidepressant exposure does not substantially increase the risk for two concerning neurodevelopmental problems -- ASD and ADHD.

Key points to consider:

• Cipralex is considered one of the safer antidepressants for pregnant women
• The typical dose ranges from 10-20mg daily
• Women already on Cipralex should not stop suddenly
• Regular prenatal care is essential
• Breastfeeding while on Cipralex is generally considered acceptable
• The decision to use Cipralex during pregnancy should balance the mother's mental health needs against potential risks, as untreated depression itself poses risks to both mother and baby, as noted in a study published in Pediatrics 1.

It is also important to note that some studies have suggested that the risks associated with prenatal antidepressant exposure may be due to confounding factors, such as maternal underlying conditions, rather than a causal effect of the exposure itself, as discussed in a study published in the Journal of Child Psychology and Psychiatry and Allied Disciplines 1.

From the FDA Drug Label

There are risks of persistent pulmonary hypertension of the newborn (PPHN) (see Data) and poor neonatal adaptation (see Clinical Considerations) with exposure to selective serotonin reuptake inhibitors (SSRIs), including Escitalopram, during pregnancy. In animal reproduction studies, both escitalopram and racemic citalopram have been shown to have adverse effects on embryo/fetal and postnatal development, including fetal structural abnormalities, when administered at doses greater than human therapeutic doses (see Data).

Cipralex (Escitalopram) in Pregnancy:

• The use of Escitalopram during pregnancy has been associated with risks of persistent pulmonary hypertension of the newborn (PPHN) and poor neonatal adaptation.
• Animal studies have shown adverse effects on embryo/fetal and postnatal development, including fetal structural abnormalities, at doses greater than human therapeutic doses.
• The estimated background risk of major birth defects and miscarriage for the indicated population is unknown, but in the U.S. general population, it is 2 to 4% and 15 to 20%, respectively.
• Women who discontinue antidepressants are more likely to experience a relapse of major depression than women who continue antidepressants.
• Key Considerations:
  • Risk of untreated depression when discontinuing or changing treatment with antidepressant medication during pregnancy and postpartum.
  • Fetal/Neonatal adverse reactions, including respiratory distress, cyanosis, apnea, seizures, and temperature instability, have been reported in neonates exposed to SSRIs, including Escitalopram, late in the third trimester.
  • The clinical picture is consistent with either a direct toxic effect of SSRIs and SNRIs or, possibly, a drug discontinuation syndrome. 2

From the Research

Cipralex in Pregnancy

• Cipralex, also known as escitalopram, is a selective serotonin reuptake inhibitor (SSRI) used to treat depression and anxiety disorders.
• The safety of Cipralex during pregnancy has been evaluated in several studies, with mixed results 3, 4, 5.
• A literature review found that paroxetine and fluoxetine have the strongest association with negative outcomes, while the associations between sertraline and citalopram with negative outcomes remain mixed and generally unsubstantiated 3.
• Escitalopram, the active ingredient in Cipralex, has been found to have a relatively safe profile during pregnancy, with some cases of major malformations reported, but at a rate substantially in the range of those reported in unexposed women 4, 5.
• Exposure to escitalopram during pregnancy may be associated with an increased risk of perinatal complications, such as lower rates of live births and higher rates of newborns with low birth weight 4, 5.
• The safety of Cipralex during breastfeeding has also been evaluated, with no adverse effects reported in the few studies published 4, 5.

Key Findings

• A study found that escitalopram is at least as effective in the treatment of depression and anxiety as other SSRIs, and has a relatively fast onset of action and minimal interactions with other drugs 6.
• Another study found that escitalopram is generally better tolerated than other antidepressants, and may have cost-effectiveness and cost-utility advantages 6.
• The available data seem to support the notion that escitalopram might be considered safe during pregnancy and breastfeeding, particularly as far as major malformations are concerned 4, 5.

Studies

• A prospective clinical trial found that citalopram, the racemic mixture of which escitalopram is a part, resulted in low maternal trough plasma concentrations and minimal exposure of infants to citalopram during lactation 7.
• A literature review found that sertraline and citalopram should be first-line drug treatments for anxiety and depression in pregnant women in the SSRI class 3.