Abstract
Objective: To systematically review the available published evidence on the fetal safety of Levetiracetam with focus on birth defects. Results: Eight studies met the inclusion criteria; five pregnancy registries and one population based cohort study. A total of 27 major congenital malformations were reported among 1213 Levetiracetam monotherapy - exposed pregnant women, yielding an overall major malformation rate of 2.2% (27/1213) [95% confidence interval of 1.53-3.22]. In contrast, Levetiracetam polytherapy was associated with significantly higher malformation rate of 6.3% (34/541) [95% CI of 4.53-8.65] ( P<. 0.001). Additionally 2 studies investigating child neurodevelopment in Levetiracetam - exposed children revealed that the measured achievements were well above those children exposed to valproic acid, and similar to unexposed controls. Conclusions: The current evidence suggests that the overall risk of major malformation after first trimester exposure to Levetiracetam is within the population baseline risk of 1-3%, with no apparent adverse effects on long term child development.
| Original language | English |
|---|---|
| Pages (from-to) | 40-45 |
| Number of pages | 6 |
| Journal | Reproductive Toxicology |
| Volume | 46 |
| DOIs | |
| State | Published - Jul 2014 |
| Externally published | Yes |
Keywords
- Adverse outcome
- Birth defects
- Levetiracetam
- Pregnancy
- Safety