title: Pregnancy outcomes following gabapentin use: results of a prospective comparative cohort study.
abstract: OBJECTIVE
  Our objectives were to 1) determine whether first-trimester use of gabapentin is associated with an increased risk for major malformations; 2) examine rates of spontaneous abortions, therapeutic abortions, stillbirths, mean birth weight and gestational age at delivery; and 3) examine rates of poor neonatal adaptation syndrome following late pregnancy exposure.
  
  
  METHODS
  The study design was prospective. Women were included who initially contacted the services between 5 and 8 weeks with a comparison group of women exposed to nonteratogens, collected in a similar manner.
  
  
  RESULTS
  We have data on 223 pregnancy outcomes exposed to gabapentin and 223 unexposed pregnancies. The rates of major malformations were similar in both groups (p = 0.845). There was a higher rate of preterm births (p = 0.019) and low birth weight <2,500 g (p = 0.033) in the gabapentin group. Among infants who were exposed to gabapentin up until delivery, 23 of 61 (38%) were admitted to either the neonatal intensive care unit or special care nursery for observation and/or treatment, vs 6 of 201 (2.9%) live births in the comparison group (p < 0.001). There were 2 cases of possible poor neonatal adaptation syndrome in neonates exposed to gabapentin close to delivery, compared with none in the comparison group, although it must be noted that these infants were concomitantly exposed to other psychotropic drugs. Among the women who took gabapentin, the major indications were pain (n = 90; 43%) and epilepsy (n = 71; 34%); the remainder were for other indications, mostly psychiatric.
  
  
  CONCLUSIONS
  Our results suggest that although this sample size is not large enough to make any definitive conclusions, and there was no comparator group treated with other antiepileptic drugs, gabapentin use in pregnancy does not appear to increase the risk for major malformations. This finding and the increased risk for low birth weight and preterm birth require further investigation.
authors.affiliation: Motherisk Program, Department of Pediatrics, The Hospital for Sick Children, The University of Toronto, Canada.
authors.forename: Hisaki
authors.initials: H
authors.lastname: Fujii
authors.forename: Akash
authors.initials: A
authors.lastname: Goel
authors.forename: Nathalie
authors.initials: N
authors.lastname: Bernard
authors.forename: Alessandra
authors.initials: A
authors.lastname: Pistelli
authors.forename: Laura M
authors.initials: LM
authors.lastname: Yates
authors.forename: Sally
authors.initials: S
authors.lastname: Stephens
authors.forename: Jungyeol Y
authors.initials: JY
authors.lastname: Han
authors.forename: Doreen
authors.initials: D
authors.lastname: Matsui
authors.forename: Fatwa
authors.initials: F
authors.lastname: Etwell
authors.forename: Thomas R
authors.initials: TR
authors.lastname: Einarson
authors.forename: Gideon
authors.initials: G
authors.lastname: Koren
authors.forename: Adrienne
authors.initials: A
authors.lastname: Einarson
mesh_terms: D000014:Abnormalities, Drug-Induced / Q000453:epidemiology* / Q000209:etiology; D000328:Adult; D000588:Amines / Q000009:adverse effects*; D000927:Anticonvulsants / Q000009:adverse effects*; D003509:Cyclohexanecarboxylic Acids / Q000009:adverse effects*; D005260:Female; D000077206:Gabapentin; D006801:Humans; D011247:Pregnancy; D011256:Pregnancy Outcome; D011446:Prospective Studies; D005680:gamma-Aminobutyric Acid / Q000009:adverse effects*
chemical_list: D000588:Amines; D000927:Anticonvulsants; D003509:Cyclohexanecarboxylic Acids; D005680:gamma-Aminobutyric Acid; D000077206:Gabapentin
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