Pregabalin Safety During Pregnancy
Pregabalin should be avoided during pregnancy due to potential risks of fetal structural abnormalities and developmental toxicity observed in animal studies, with no adequate well-controlled studies in pregnant women to confirm safety. 1
Evidence on Pregabalin in Pregnancy
- FDA labeling indicates pregabalin has shown increased incidences of fetal structural abnormalities and developmental toxicity in animal reproduction studies, including skeletal malformations, retarded ossification, and decreased fetal body weight 1
- Animal studies demonstrated lethality, growth retardation, and nervous and reproductive system functional impairment in offspring of rats given pregabalin during gestation and lactation 1
- The FDA requires pregnant patients taking pregabalin to enroll in the North American Antiepileptic Drug (NAAED) Pregnancy Registry to monitor outcomes 1
Research Findings
- A 2023 Nordic population-based cohort study found adjusted prevalence ratios of 1.14 (0.98-1.34) for major congenital malformations and 1.72 (1.02-2.91) for stillbirth when comparing pregabalin exposure versus no exposure 2
- The same study found an adjusted hazard ratio of 1.29 (1.03-1.63) for ADHD in children with prenatal pregabalin exposure, though this attenuated when using active comparators 2
- A 2018 review of four studies on pregabalin in pregnancy found mixed results but was limited by underpowered analyses 3
- Animal studies in mice have shown potential teratogenic effects of pregabalin even at lower doses, with limb deformities being the most common abnormality 4
Clinical Decision Making
- When considering medication for pregnant patients:
- Antiepileptic drugs should be avoided in the first trimester when risk of congenital malformations is greatest 5
- The use of newer medications during pregnancy may be justified only if benefits clearly outweigh risks 5
- The lowest recommended dose should be used initially with adjustments based on clinical response 5
Recommendations for Practice
- For pregnant patients requiring pregabalin:
- Consider alternative medications with better established safety profiles during pregnancy
- If pregabalin must be used, ensure enrollment in the NAAED Pregnancy Registry 1
- Inform patients about potential risks including increased risk of major congenital malformations and possible neurodevelopmental effects 2
- Monitor pregnancies closely with appropriate prenatal screening 1
Breastfeeding Considerations
- FDA labeling states that pregabalin passes into breast milk, but it is unknown if it can harm the baby 1
- Breastfeeding is not recommended while taking pregabalin according to FDA guidance 1
Common Pitfalls
- Failing to discuss alternative treatment options with better established safety profiles
- Not enrolling pregnant patients taking pregabalin in the pregnancy registry
- Continuing pregabalin during pregnancy without clear documentation of risk-benefit assessment
- Overlooking the need for enhanced fetal monitoring when pregabalin is deemed necessary during pregnancy