title: Topiramate use during pregnancy and major congenital malformations in multiple populations.
abstract: BACKGROUND
  We measured birth prevalence of major congenital malformations (MCMs) after topiramate use during pregnancy to screen for a possible signal of increased risk.
  
  
  METHODS
  Using four healthcare databases, we identified three cohorts of pregnant women: cohort 1, used topiramate during the first trimester; cohort 2, used topiramate or another antiepileptic drug previously but not during pregnancy; and cohort 3, were pregnant and did not use topiramate but had indications for use individually matched to those of users. Cohort 1 was compared with cohorts 2 and 3. MCMs were a code for any major congenital malformation dated within 30 days of the delivery date on the mother's claims or within 365 days after infant birth date, excluding a genetic or syndromic basis, and with procedure or healthcare usage consistent with the MCM diagnosis code in the 365 days after infant birth.
  
  
  RESULTS
  Of the 10 specific common MCMs evaluated, 1 (conotruncal heart defects) had a prevalence ratio greater than 1.5 for both primary comparisons, and 4 (ventricular septal defect, atrial septal defect, hypospadias, coarctation of the aorta) had a prevalence ratio greater than 1.5 for one of the two comparisons. Following screening of organ systems with elevated MCMs, the prevalence ratio was greater than 1.5 for patent ductus arteriosus in both comparisons and for obstructive genitourinary defects in one comparison.
  
  
  CONCLUSIONS
  To evaluate a large number of MCMs across many pregnancies, we used crude methods for detecting potential signals. Therefore, these results should be seen as potential signals, not causal.
authors.affiliation: Pharmacoepidemiology and Risk Management, RTI Health Solutions, RTI International, Research Triangle Park, North Carolina.
authors.forename: Patricia
authors.initials: P
authors.lastname: Tennis
authors.forename: K Arnold
authors.initials: KA
authors.lastname: Chan
authors.forename: Suellen M
authors.initials: SM
authors.lastname: Curkendall
authors.forename: De-Kun
authors.initials: DK
authors.lastname: Li
authors.forename: Daniel
authors.initials: D
authors.lastname: Mines
authors.forename: Craig
authors.initials: C
authors.lastname: Peterson
authors.forename: Elizabeth B
authors.initials: EB
authors.lastname: Andrews
authors.forename: Brian
authors.initials: B
authors.lastname: Calingaert
authors.forename: Hong Y
authors.initials: HY
authors.lastname: Chen
authors.forename: Gaurav
authors.initials: G
authors.lastname: Deshpande
authors.forename: Nicholas
authors.initials: N
authors.lastname: Everage
authors.forename: Crystal N
authors.initials: CN
authors.lastname: Holick
authors.forename: Nicole M
authors.initials: NM
authors.lastname: Meyer
authors.forename: Ella T
authors.initials: ET
authors.lastname: Nkhoma
authors.forename: Sherry
authors.initials: S
authors.lastname: Quinn
authors.forename: Kenneth J
authors.initials: KJ
authors.lastname: Rothman
authors.forename: Daina B
authors.initials: DB
authors.lastname: Esposito
mesh_terms: D000014:Abnormalities, Drug-Induced / Q000453:epidemiology*; D015331:Cohort Studies; D005260:Female; D005632:Fructose / Q000009:adverse effects / Q000031:analogs & derivatives*; D006801:Humans; D011247:Pregnancy; D015995:Prevalence; D018570:Risk Assessment; D000077236:Topiramate; D014481:United States / Q000453:epidemiology
chemical_list: D000077236:Topiramate; D005632:Fructose
keywords: FORTRESS; cardiac malformations; epidemiology; major malformations; topiramate