Is gabapentin (Neurontin) safe to use during pregnancy?

Gabapentin Safety During Pregnancy

Gabapentin should be avoided during pregnancy unless the potential benefit clearly justifies the potential risk to the fetus, as there is evidence of developmental toxicity in animal studies and emerging concerns in human data. 1

Risk Assessment

FDA Classification and Animal Studies

• Gabapentin is classified as Pregnancy Category C by the FDA 1
• Animal studies show concerning findings:
  • In mice: Embryo-fetal toxicity (skeletal variations) at doses similar to clinical doses 1
  • In rats: Adverse effects on offspring development (hydroureter/hydronephrosis) at all tested doses 1
  • In rabbits: Increased embryo-fetal mortality at all tested doses 1
  • Marked decrease in neuronal synapse formation in neonatal mice, corresponding to third trimester exposure in humans 1

Human Data

• Recent systematic review (2024) found gabapentin exposure during pregnancy associated with:

  • Increased risk of preeclampsia
  • Increased risk of preterm birth
  • Increased risk of small-for-gestational age infants
  • Increased NICU admission rates 2

• Concerns have been raised about neonatal withdrawal syndrome following in utero gabapentin exposure 3, 4

  • Case reports document withdrawal symptoms in neonates requiring gradual tapering of the drug 4

Clinical Considerations

Maternal Benefits vs. Fetal Risks

• Use of gabapentin should be limited to situations where:
  1. Alternative safer medications have failed or are contraindicated
  2. The condition being treated poses greater risk to maternal and fetal health than the medication itself
  3. The lowest effective dose is used

Breastfeeding Considerations

• Gabapentin is secreted into human milk with a maximum infant dose of approximately 1 mg/kg/day 1
• The FDA states: "Because the effect on the nursing infant is unknown, Gabapentin should be used in women who are nursing only if the benefits clearly outweigh the risks" 1

Management Recommendations

Pre-pregnancy Planning

• Women with epilepsy or chronic pain conditions should discuss medication options before conception
• Consider transitioning to medications with better established safety profiles during pregnancy when possible

During Pregnancy

• If gabapentin must be used during pregnancy:
  • Use the lowest effective dose
  • Monitor closely for maternal complications (preeclampsia)
  • Increase fetal surveillance for growth restriction
  • Prepare for potential preterm birth and NICU admission

Postpartum Period

• Monitor newborns for signs of withdrawal:
  • Irritability
  • Tremors
  • Feeding difficulties
  • Respiratory distress
• Consider gradual tapering rather than abrupt discontinuation if withdrawal symptoms occur 4
• Weigh risks and benefits of breastfeeding based on maternal dose and infant condition

Alternative Approaches

For women requiring treatment during pregnancy:

• For epilepsy: Consider lamotrigine or levetiracetam, which have better established safety profiles
• For neuropathic pain: Consider non-pharmacological approaches first (physical therapy, acupuncture)
• For anxiety disorders: Consider psychotherapy and safer medication options

Important Caveat

The North American Antiepileptic Drug (NAAED) Pregnancy Registry provides ongoing monitoring of outcomes for women taking antiepileptic drugs during pregnancy. Physicians should recommend enrollment for pregnant patients taking gabapentin 1.

Human Medical Genetics