Australian Registry (Monotherapy) |
Valproate = 16.8%, Carbamazepine = 3.8%, Lamotrigine = 0%, Phenytoin = 5.9% |
RR = 5.6 (2.42–12.92) for valproate vs other AEDs |
Reference: Vajda et al. (11) |
Finnish Birth Registry (Monotherapy) |
Valproate = 10.7%; OR = 4.18 (2.31–7.57) vs controls |
Carbamazepine = 3.5% |
Reference: Artama et al. (12) |
European Surveillance of Congenital Anomalies (EUROCAT) (Monotherapy) |
No evidence of increased isolated orofacial clefts relative to other malformations for lamotrigine monotherapy. |
Reference: Dolk et al. (22) |
International Lamotrigine Registry (Polytherapy) |
12.5% with valproate vs 2.7% no valproate |
RR = 4.55 (1.63–12.69) |
Reference: Cunnington et al. (13) |
Neurodevelopmental Effects of Antiepileptic Drugs (NEAD Study) (Monotherapy: major malformations and fetal deaths) |
Valproate = 20.3%, Carbamazepine = 8.2%, Lamotrigine = 1.0%, Phenytoin = 10.7% |
RR = 4.59 (2.07–10.18) for valproate vs other AEDs |
Reference: Meador et al. (14) |
North America Registry (Monotherapy) |
Phenobarbital = 6.5%; RR = 2 (0.9–4.5) vs other AEDs |
Valproate = 10.7%, OR = 4.0 (2.1–7.4) vs other AEDs |
Other AEDs = 2.9% |
General population = 1.62% |
Lamotrigine 2.7% (cleft lip/palate 0.73%) |
Carbamazepine 2.6% (cleft lip/palate 0.023%; neural tube 0.014%) |
Reference: Wyszynski et al., Holmes et al., Holmes et al., Hernandez-Diaz et al. (15,19,22,23) |
Swedish Birth Registry (Monotherapy) |
Valproate = 9.7%, Carbamazepine = 4.0% |
OR = 2.51 (1.43–4.86) for valproate vs carbamazepine |
Reference: Wide et al. (16) |
UK Registry (Monotherapy) |
Valproate = 6.2%, Carbamazepine = 2.2%, Lamotrigine = 3.2% |
OR = 2.97 (1.65–5.35) for valproate vs carbamazepine |
Reference: Morrow et al. (17) |