levetiracetam and Abortion--Spontaneous

To evaluate pregnancy outcomes among women participating in the antiepileptic drug (AED) Levetiracetam Registry (LEV-Registry), and to review the impact of using two other registries' outcome definitions on the number of major congenital malformations (MCMs).. This US-based prospective study (ClinicalTrials.gov NCT00345475) was overseen by an independent Expert Panel. Women exposed to levetiracetam at any time during pregnancy enrolled, directly, or via their healthcare provider. The primary outcome was prevalence of MCMs, defined according to a modified version of the Metropolitan Atlanta Congenital Defects Program criteria.. Of 491 women enrolled, 465 (94.7%) had a documented outcome. Most (92.3%) received levetiracetam for epilepsy; 323 (69.4%) as monotherapy and 142 (30.5%) as polytherapy. With three twin pregnancies, there were 468 outcomes-444 livebirths, 3 stillbirths, 19 miscarriages, and 2 terminations. Based on the MCM definition used by LEV-Registry, 46 infants among 444 livebirths had MCMs resulting in 10.4% (95% CI 7.7, 13.6) for overall prevalence, 9.4% (95% CI 6.4, 13.2) with monotherapy, and 12.6% (95% CI 7.5, 19.4) with polytherapy. When MCM reports were reviewed independently by staff at EURAP (International Registry of AEDs) and North American AED Pregnancy Registry according to their respective criteria, only 22 and 7 infants of the 46, respectively, were classified as having MCMs.. The LEV-Registry Expert Panel did not find evidence suggestive of teratogenic association with prenatal exposure to levetiracetam. The substantial differences in which physical findings were considered MCMs highlight the major impact of pregnancy registry methodology on MCM prevalence estimates.

Topics: Abnormalities, Drug-Induced; Abortion, Spontaneous; Adult; Anticonvulsants; Congenital Abnormalities; Epilepsy; Female; Humans; Levetiracetam; Pregnancy; Pregnancy Complications; Pregnancy Outcome; Prevalence; Prospective Studies; Registries; Stillbirth; United States

To ascertain the risk of spontaneous fetal loss (SPFL) in women with epilepsy (WWE) on antiepileptic drugs (AED), and explore the association between specific AED usage and risk of SPFL.. We identified all SPFL (including stillbirths) among pregnancies registered at Kerala Registry for Epilepsy and Pregnancy between 1998 and 2015. Rates of SPFL were compared between the AED exposed and unexposed groups.. There were 139 SPFL out of 1987 eligible pregnancies. The AED exposed had excess SPFL (7.4%, 134 out of 1809, Odds Ratio [OR] 2.77, 95% Confidence Interval [CI] 1.17-6.39) than AED unexposed (2.8%, 5 out of 178). The adjusted OR (95% CI) for SPFL for monotherapies with levetiracetam, phenobarbitone and clobazam were comparable to unexposed, while it was significantly higher for topiramate (OR 38.86, CI 5.02-301.19), lamotrigine (OR 13.33, CI 1.41-125.78), oxcarbazepine (OR 7.53, CI 1.54-36.89), valproate (OR 6.92, CI 1.70-28.18), phenytoin (OR 5.82, CI 1.43-23.73) and carbamazepine (OR 3.53, CI 1.15-10.90). With reference to levetiracetam, only topiramate had significantly higher SPFL (OR 11.14, CI 1.56-79.55).. SPFL risk is increased in pregnancies with AED exposure, being least with levetiracetam and highest with topiramate.

Topics: Abortion, Spontaneous; Adult; Anticonvulsants; Epilepsy; Female; Humans; India; Levetiracetam; Prospective Studies; Registries; Risk Factors; Topiramate