Title: Outcomes following exposure to the antiepileptic drug lacosamide during pregnancy – results from a global safety database (P5.231)
Abstract: Objective: To evaluate pregnancy outcomes in women exposed to lacosamide during pregnancy using data from the UCB global safety database. Background: Lacosamide has been approved as adjunctive therapy in focal epilepsy since 2008; however, data on pregnancy outcomes remain limited. Design/Methods: Prospective reports (defined as ongoing pregnancies with no abnormal findings when first reported) up to Oct 2015 were included. Retrospective reports are not presented given the well-established bias toward adverse outcomes. Results: Of 250 maternal exposure pregnancies, outcomes were known for 154 (61.6%); 101 (65.5%) were prospective. Mean age of women at estimated delivery date was 30.1±5 years. Lacosamide was used as monotherapy by 16 (15.8%) and as adjunctive therapy by 84 (83.2%) women during pregnancy (1% unknown). Among women on polytherapy, 16.8%, 47.5% and 35.6% were taking 1, 2 and ≥3 concomitant AEDs, respectively; the most common were levetiracetam (38.0%), lamotrigine (34.5%) and carbamazepine (21.4%). Most pregnancies resulted in live births (75/101, 74.2%), including 14 of the 16 (87.5%) monotherapy cases. Other outcomes included 11 spontaneous and 15 induced abortions. Most neonates had normal gestational age at outcome (86.7%) and birth weight (80.9%). Of 69 live births with detailed exposure data, 66 pregnancies were exposed during the first trimester, including the 14 monotherapy live births. Six cases of malformation with no discernible patterns were identified; five occurred with polytherapy exposure. Conclusions: Most reports resulted in healthy live births. Interpretation of malformation results is limited by the lack of comparator group, and confounded by the use of concomitant AEDs. Direct comparisons with malformation rates in other populations cannot be made due to the nature of safety reporting. Furthermore, given the small sample size, conclusions on the potential risk of malformation due to lacosamide exposure during pregnancy cannot be drawn, and further monotherapy data are required. Study Supported by: UCB Pharma Disclosure: Employee of UCB Pharma,,,,I have stock or stock options as a full time employee of UCB Pharma,, Dr. Cooney has received personal compensation for activities with UCB Pharma as a consultant. Dr. Craig has received personal compensation for activities with UCB-Pharma and Eisai. Dr. Taeter has received personal compensation for activities with UCB Pharma as an employee. Dr. Tofighy has received personal compensation for activities with UCB Pharma as a consultant. Dr. Dedeken has received personal compensation for activities with UCB Pharma as an employee.
Publication Year: 2017
Publication Date: 2017-04-18
Language: en
Type: article
Indexed In: ['crossref']
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Cited By Count: 6
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