title: Effect of dose on the frequency of major birth defects following fetal exposure to lamotrigine monotherapy in an international observational study.
abstract: Data from the International Lamotrigine Pregnancy Registry were analyzed to examine the effect of maximal first-trimester maternal dose of lamotrigine monotherapy on the risk of major birth defects (MBDs). Among 802 exposures, the frequency of MBDs was 2.7% (95% confidence interval [CI] 1.8-4.2%). The distribution of dose did not differ between infants with and those without MBDs (mean 248.3 milligrams per day [mg/day] and 278.9 mg/day, respectively, median 200 mg/day for both groups). A logistic regression analysis showed no difference in the risk of MBDs as a continuous function of dose (summary odds ratio [OR] per 100 mg increase =0.999, 95% CI 0.996-1.001). There was also no effect of dose, up to 400 mg/day, on the frequency of MBDs.
authors: GlaxoSmithKline, Harlow, Essex, United Kingdom. Marianne.C.Cunnington@gsk.com
authors: Marianne
authors: M
authors: Cunnington
authors: Sandy
authors: S
authors: Ferber
authors: George
authors: G
authors: Quartey
mesh_terms: D000014:Abnormalities, Drug-Induced / Q000453:epidemiology; D000927:Anticonvulsants / Q000009:adverse effects* / Q000627:therapeutic use; D000013:Congenital Abnormalities / Q000453:epidemiology* / Q000209:etiology; D019992:Databases as Topic / Q000706:statistics & numerical data; D004305:Dose-Response Relationship, Drug; D004827:Epilepsy / Q000188:drug therapy*; D005260:Female; D006801:Humans; D007391:International Cooperation; D000077213:Lamotrigine; D016015:Logistic Models; D008431:Maternal-Fetal Exchange; D011247:Pregnancy; D011248:Pregnancy Complications / Q000188:drug therapy*; D011261:Pregnancy Trimester, First; D011446:Prospective Studies; D012042:Registries / Q000706:statistics & numerical data; D012307:Risk Factors; D014227:Triazines / Q000009:adverse effects* / Q000627:therapeutic use
chemical_list: D000927:Anticonvulsants; D014227:Triazines; D000077213:Lamotrigine