The following report discusses our review of the non-clinical and clinical data relating to the safety of antiepileptic drugs during pregnancy. A study in the nationwide Swedish Medical birth register (Margulis et al 2019) reported on the outcomes for 562 pregabalin exposed infants compared to those exposed to lamotrigine. However, it is considered there is a strong possibility that residual confounding may have had an effect on the pregabalin analyses given the distinct profile of pregabalin users (younger, less well-educated and more likely to be obese or smokers). Non-clinical studies report on neurobehavioral effects in the offspring of rats given pregabalin during gestation and lactation but at doses which generated plasma concentrations higher than human therapeutic doses. Non-clinical studies also suggest that neurobehavioural effects can occur following dosing of juvenile rats at doses relevant to human therapeutic doses, however, reversibility has been observed upon discontinuation of dosing. Published scientific literature has reported that phenytoin exposure during pregnancy can induce behavioural abnormalities in animal offspring at plasma concentrations relevant to human therapeutic doses.
- Given the frontal projections of the genu, it is not surprising that executive functions mediated by these areas could be correlated with microstructural abnormalities as detected by DTI in our study.
- The left side of the brain specialises in logical, linear, analytical processes and the right side specialises in intuitive, holistic, imaginative processes (gross simplification).
- Non-clinical studies report reduced fetal body weights in rats and rabbits following exposure to pregabalin during pregnancy but this occurred at plasma concentrations sufficiently higher than human therapeutic concentrations.
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- They also provide clinical guidance on how to manage specific conditions in England.
Key findings for phenytoin
Click here for more information on PMLD from UKs NHS.See also Developmental Delay and Global Developmental Delay, above. Obsessive Compulsive Disorder (OCD) / Obsessive BehavioursOCD is a diagnosable medical condition where a person feels unable to control a compulsion to do things repeatedly or organise things is a very rigid way. There are many on-line resources about OCD including from the UKs NHS Website, click here.Many with CVI struggle to find things. To help people with CVI find things, they need them to stay where they are, so they can remember where to find them (because looking is difficult). This can lead to the person becoming very particular about things not being moved, to the point where the behaviour may be considered obsessive. This is different from the condition OCD, although potentially could lead to it over time, however we are unaware of any such recorded cases at present.
Human therapeutic dose
Consequently, the available non-clinical and clinical data has been reviewed in order to determine whether the accumulating data raises any new safety concerns or changes the current understanding about the safety of use during pregnancy of these prioritised antiepileptic drugs. The risk to the unborn baby depends on many different things, including which epilepsy medicines are used during pregnancy. Some epilepsy medicines have a higher risk of harming a baby during pregnancy than others. The risk of harm to the baby may also be increased if a woman is taking a high dose of an epilepsy medicines or she is taking more than one epilepsy medicine, especially if this includes valproate or valproic acid. These clinical studies, involving around 1800 pregnancies exposed to phenobarbital (including 600 pregnancies exposed in the first trimester), show an increased risk of major congenital malformations following phenobarbital exposure compared with either unexposed women without epilepsy or unexposed women with epilepsy. While there is some variation in incidence rates with the largest meta-analysis by Weston et al 2016 showing a prevalence of 7.1%, other studies broadly support incidence rates of malformations in offspring of phenobarbital exposed women of around 5–6%).
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There are extremely limited clinical data available to inform on the effect of topiramate exposure during pregnancy and the risk of neurodevelopmental disorders in the offspring. Data from a very small study by Rihtman et al (2012), that involved only 9 children whose mothers had taken topiramate during pregnancy suggested that, compared with control children, topiramate had an adverse effect on cognitive, motor, and behavioural outcomes, as well as on IQ score, and motor and visual spatial skills. In contrast, a retrospective observational study in the UK Epilepsy and Pregnancy Registry (Bromley et al 2016b) reported on data for 27 children who had prenatal exposure to topiramate and the findings did not suggest reductions in the cognitive abilities of the children.
The conclusions of this assessment are based on an evaluation of the available non-clinical and clinical data. The assessment takes into account the methodology, including the quality of data, how it was collected, the existence of a non-exposed group or control group, the type of controls, and if possible, the inclusion of foetuses aborted due to malformation, and so on. To allow a cerebrumiq proper evaluation of the reliability of the data, the available studies must be of adequate scientific quality. This public assessment report summarises the main evidence and key findings for the antiepileptic drugs considered in this review. It also presents the conclusions of the Commission on Human Medicines and its Neurology, Pain and Psychiatry Expert Advisory Group (NPPEAG). The epilepsy medicine, valproate or valproic acid (▼; brand names Epilim, Depakote, Convulex, Episenta, Epival, Kentlim, Syonell, Orlept, Valpal) can seriously harm an unborn baby if taken by the mother during pregnancy.