Antiepileptic drugs in women with epilepsy during pregnancy

Gedzelman, Evan; Meador, Kimford J.

doi:10.1177/2042098611433192

Cited by 41 publications

(27 citation statements)

References 114 publications

(346 reference statements)

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“…The most common medical conditions in women of reproductive age include epilepsy and depression. In the US, approximately 0.4% of pregnant women take an anti-epileptic medication [27], and almost 7% take an anti-depressant around the time of conception (though many stop after the pregnancy is discovered) [28]. In Europe, 3% of pregnant women report anti-depressant use [29] while in India, 8% of women take medication for any indication during pregnancy [30].…”

Section: In-utero Antiretroviral Therapy Exposurementioning

confidence: 99%

Surveillance monitoring for safety of in utero antiretroviral therapy exposures: current strategies and challenges

Zash

Williams

Sibiude

et al. 2016

Expert Opinion on Drug Safety

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Introduction The use of antiretroviral therapy (ART) in pregnancy to prevent vertical HIV transmission has been one of the most successful public health programs in the last decade. As a result, an unprecedented number of women are taking ART at conception and during pregnancy. Given few randomized studies evaluating safety of different ART regimens in pregnancy, ongoing drug safety surveillance is critical. Areas Covered This review aims to provide a rationale for ART drug safety surveillance, describe changing patterns of ART use and summarize current surveillance efforts in both low-resource and high-resource settings. Additionally, biostatistical approaches to and challenges in analysis of observational surveillance data are discussed. Expert Opinion The global landscape of ART use in pregnancy is rapidly increasing and evolving. Any increase in adverse effects of in-utero exposure to ART has the potential to reduce the impact of improvements in infant morbidity and mortality gained from decreased vertical HIV transmission. ART drug safety surveillance should therefore be a critical piece of programs to prevent mother to child transmission in both high- and low-resource settings. Current surveillance efforts could be strengthened with long-term follow-up of exposed children, pooling of data across cohorts and standardized approaches to analysis.

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Section: In-utero Antiretroviral Therapy Exposurementioning

confidence: 99%

Surveillance monitoring for safety of in utero antiretroviral therapy exposures: current strategies and challenges

Zash

Williams

Sibiude

et al. 2016

Expert Opinion on Drug Safety

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“…Lamotrigine (LTG) is a clinically viable option to treat epilepsy and bipolar disorder in pregnant women 1,2 in large part due to low relative risks of teratogenic complications and adverse neurodevelopmental effects compared to other medication options. [3][4][5][6][7][8] However, LTG pharmacokinetics markedly change during pregnancy [9][10][11][12][13][14][15][16][17][18] and if a woman with epilepsy remains on her pre-pregnancy LTG dose, concentrations may decrease significantly and lead to an increase in seizure frequency for some women. 10,13,19 The clinical impact of declining LTG concentrations during pregnancy in women with bipolar disorder is less clear.…”

Section: Introductionmentioning

confidence: 99%

Model‐based lamotrigine clearance changes during pregnancy: clinical implication

Polepally

Pennell

Brundage

et al. 2014

Ann Clin Transl Neurol

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Objective The objective of the study was to characterize changes in the oral clearance (CL/F) of lamotrigine (LTG) over the course of pregnancy and the postpartum period through a model-based approach incorporating clinical characteristics that may influence CL/F, in support of developing clinical management guidelines. Methods Women receiving LTG therapy who were pregnant or planning pregnancy were enrolled. Maternal blood samples were collected at each visit. A pharmacokinetic analysis was performed using a population-based, nonlinear, mixed-effects model. Results A total of 600 LTG concentrations from 60 women (64 pregnancies) were included. The baseline LTG CL/F was 2.16 L/h with a between-subject variability of 40.6%. The influence of pregnancy on CL/F was described by gestational week. Two subpopulations of women emerged based on the rate of increase of LTG CL/F during pregnancy. The gestational age-associated increase in CL/F displayed a ten-fold higher rate in 77% of the women (0.118 L/h/week) compared to 23% (0.0115 L/h/week). The between-subject variability in these slopes was 43.0%. The increased CL/F at delivery declined to baseline values with a half-life of 0.55 weeks. Interpretation The majority of women had a substantial increase in CL/F from 2.16 to 6.88 L/h by the end of pregnancy, whereas 23% of women had a minimal increase. An increase in CL/F may correspond to decreases in LTG blood concentrations necessitating the need for more frequent dosage adjustments and closer monitoring in some pregnant women with epilepsy. Postpartum doses should be tapered to preconception dose ranges within 3 weeks of delivery.

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“…A prime example is the use of antiepileptic drugs (AEDs) [42]. For women with seizure disorders, many questions must be addressed even prior to conception.…”

Section: Discussionmentioning

confidence: 99%

Translational toxicology: a developmental focus for integrated research strategies

Hughes

Waters

Allen

et al. 2013

BMC Pharmacol Toxicol

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BackgroundGiven that toxicology studies the potential adverse effects of environmental exposures on various forms of life and that clinical toxicology typically focuses on human health effects, what can and should the relatively new term of "translational toxicology" be taken to mean?DiscussionOur assertion is that the core concept of translational toxicology must incorporate existing principles of toxicology and epidemiology, but be driven by the aim of developing safe and effective interventions beyond simple reduction or avoidance of exposure to prevent, mitigate or reverse adverse human health effects of exposures.The field of toxicology has now reached a point where advances in multiple areas of biomedical research and information technologies empower us to make fundamental transitions in directly impacting human health. Translational toxicology must encompass four action elements as follows:1) Assessing human exposures in critical windows across the lifespan2) Defining modes of action and relevance of data from animal models3) Use of mathematical models to develop plausible predictions as the basis for4) Protective and restorative human health interventions.The discussion focuses on the critical window of in-utero development.SummaryExposure assessment, basic toxicology and development of certain categories of mathematical models are not new areas of research; however overtly integrating these in order to conceive, assess and validate effective interventions to mitigate or reverse adverse effects of environmental exposures is our novel opportunity. This is what we should do in translational toxicology so that we have a portfolio of interventional options to improve human health that include both minimizing exposures and specific preventative/restorative/mitigative therapeutics.

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Antiepileptic drugs in women with epilepsy during pregnancy

Cited by 41 publications

References 114 publications

Surveillance monitoring for safety of in utero antiretroviral therapy exposures: current strategies and challenges

Surveillance monitoring for safety of in utero antiretroviral therapy exposures: current strategies and challenges

Model‐based lamotrigine clearance changes during pregnancy: clinical implication

Translational toxicology: a developmental focus for integrated research strategies

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