What is the pregnancy category of Cipralex (escitalopram)?

Pregnancy Category of Cipralex (Escitalopram)

Cipralex (escitalopram) is classified as FDA Pregnancy Category C, which means that animal studies have shown adverse effects on the fetus, but there are no adequate and well-controlled studies in pregnant women.

Understanding FDA Pregnancy Categories

The FDA pregnancy classification system (used until 2015) categorizes medications based on their potential risk during pregnancy:

• Category A: Safest, controlled studies show no risk
• Category B: Animal studies show no risk, but no adequate human studies
• Category C: Animal studies show adverse effects, no adequate human studies
• Category D: Evidence of human fetal risk exists
• Category X: Contraindicated in pregnancy due to proven fetal risk

Risk Assessment for Escitalopram in Pregnancy

Safety Data

• The FDA classifies escitalopram as Category C 1
• Available data from epidemiologic studies and postmarketing reports have not established an increased risk of major birth defects or miscarriage 2
• Although some cases of major malformations have been reported after maternal exposure to escitalopram during early pregnancy, the rate is substantially in the range of those reported in unexposed women 3

Potential Risks

• There are risks of persistent pulmonary hypertension of the newborn (PPHN) and poor neonatal adaptation with exposure to SSRIs, including escitalopram, during pregnancy 2
• Late pregnancy use of SSRIs may lead to increased risk for neonatal complications requiring prolonged hospitalization, respiratory support, and tube feeding 2
• Neonatal symptoms may include respiratory distress, cyanosis, apnea, seizures, temperature instability, feeding difficulty, hypoglycemia, and irritability 2

Pregnancy Registry

Healthcare providers are encouraged to register pregnant patients taking escitalopram in the National Pregnancy Registry for Antidepressants by calling 1-844-405-6185 or visiting online at womensmentalhealth.org/clinical-and-research-programs/pregnancyregistry/antidepressants/ 2

Clinical Decision-Making Algorithm

1. For women planning pregnancy:

   • Evaluate risk-benefit ratio of continuing escitalopram
   • Consider alternative treatments with better established safety profiles if appropriate

2. For pregnant women currently taking escitalopram:

   • Assess severity of maternal depression/anxiety
   • If depression is severe with high risk of relapse:
     • Continue escitalopram if benefits outweigh risks
   • If depression is mild to moderate:
     • Consider tapering medication if clinically appropriate

3. For women in third trimester:

   • Be aware of increased risk of neonatal complications
   • Consider gradual dose reduction before delivery if clinically appropriate
   • Plan for neonatal monitoring after delivery

Monitoring Recommendations

• Monitor for signs of maternal depression throughout pregnancy
• For infants exposed to escitalopram in late pregnancy, monitor for:
  • Respiratory distress
  • Feeding difficulties
  • Irritability
  • Hypotonia or hypertonia
  • Tremor and jitteriness

Important Caveats

• The FDA has replaced the ABCDX pregnancy categories with more descriptive information under the Pregnancy and Lactation Labeling Rule since 2015 1
• Untreated depression during pregnancy carries its own risks to both mother and fetus 2
• Women who discontinue antidepressants during pregnancy are more likely to experience relapse of depression 2
• Individual risk assessment should consider severity of maternal illness and potential consequences of untreated depression

Human Psychopharmacology studies suggest that escitalopram might be considered safe during pregnancy, particularly regarding major malformations, though it could be associated with increased risk of perinatal complications similar to other SSRIs 3, 4.

AI Assistant: I've provided a comprehensive answer about the pregnancy category of Cipralex (escitalopram) and important clinical considerations for its use during pregnancy.