Is Cymbalta (duloxetine) safe to use during pregnancy?

Duloxetine (Cymbalta) Use During Pregnancy

Duloxetine (Cymbalta) should be used during pregnancy only if the potential benefits outweigh the risks, as it may be associated with postpartum hemorrhage and neonatal complications when used near delivery.

Safety Profile During Pregnancy

Maternal Risks

• Use of duloxetine in the month before delivery is associated with an increased risk of postpartum hemorrhage (adjusted relative risk: 1.53; 95% CI: 1.08 to 2.18) 1
• Women who discontinue antidepressants during pregnancy are more likely to experience a relapse of major depression than those who continue treatment 1

Fetal/Neonatal Risks

• Current data have not identified a clear drug-associated risk of major birth defects or other adverse developmental outcomes 1
• Late trimester exposure to duloxetine and other SNRIs/SSRIs can lead to neonatal complications requiring:
  • Prolonged hospitalization
  • Respiratory support
  • Tube feeding 1
• Neonatal complications may include:
  • Respiratory distress
  • Cyanosis
  • Apnea
  • Seizures
  • Temperature instability
  • Feeding difficulties
  • Hypoglycemia
  • Hypertonia/hypotonia
  • Tremor and irritability 1

Animal Studies

• In animal studies, duloxetine showed:
  • No evidence of malformations at doses up to 3-6 times the maximum recommended human dose
  • Decreased fetal weights
  • Decreased pup survival and weight at birth
  • Increased reactivity behaviors in pups 1

Decision-Making Algorithm

1. Assess severity of maternal depression

   • Untreated depression carries significant risks to both mother and fetus
   • Consider non-pharmacological approaches first for mild depression

2. Evaluate trimester-specific risks

   • First trimester: Limited data suggest no significant increase in major malformations
   • Third trimester: Higher risk of neonatal complications and postpartum hemorrhage

3. Consider alternative medications with better established safety profiles

   • SSRIs like sertraline may have more safety data in pregnancy

4. If duloxetine is continued:

   • Use lowest effective dose
   • Consider gradual discontinuation 2-4 weeks before delivery to minimize neonatal effects
   • Plan for close monitoring of the neonate after birth

Breastfeeding Considerations

• Duloxetine is present in breast milk but in small amounts (less than 1% of maternal dose) 1, 2
• Monitor breastfed infants for:
  • Sedation
  • Poor feeding
  • Poor weight gain 1

Clinical Monitoring Recommendations

• For women taking duloxetine during pregnancy:

  • Regular assessment of maternal mental health
  • Fetal growth monitoring
  • Plan for neonatal observation if used near delivery

• For women discontinuing duloxetine during pregnancy:

  • Close monitoring for depression relapse
  • Have a treatment plan ready if symptoms worsen

Common Pitfalls to Avoid

1. Abrupt discontinuation: Can lead to withdrawal symptoms and depression relapse
2. Ignoring maternal depression: Untreated depression carries significant risks to both mother and fetus
3. Failure to plan for neonatal monitoring: If duloxetine is used in late pregnancy, the neonate should be observed for poor neonatal adaptation syndrome
4. Overlooking postpartum hemorrhage risk: Women using duloxetine near delivery should be monitored for excessive bleeding

The decision to use duloxetine during pregnancy requires careful weighing of maternal mental health needs against potential risks, with consideration of alternative treatments when possible.