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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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.

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Limited published non-clinical studies report of teratogenicity in rodents however, in company sponsored studies no teratogenicity was reported in rodents and rabbits at plasma concentrations far exceeding human therapeutic doses. In considering the conflicting data regarding the teratogenic potential of pregabalin, no firm conclusions can be drawn of its potential teratogenic effect. Prescribing trend data show that prescribing prevalence rates for pregabalin are high and have been increasing over cerebrumiq time but this is reflective of the increasing use in the pain and anxiety indications. In June 2019, the rate was 75.94 prescriptions per 10,000 eligible women of childbearing age women (CPRD GOLD), making pregabalin the second most frequently prescribed antiepileptic drug in women of childbearing age among the drugs which have been prioritised for review.

Lists of linear words does not engage the intuitive, right side of our brain. A much more effective way to do this is to use a technique called Mind Mapping®. Regular use of such visual, organic, branching techniques is brain-friendly, and encourages learning through visualisation and realisation of the interconnectedness of our internal and external worlds.

Key findings for phenytoin

It is the most common facial birth defect in the UK affecting around 1 in every 700 babies. The corporate world for example could optimise its training budgets much more effectively if trainers and employees utilised this knowledge, and students studying could spend less time on revision yet achieve far better results in their examinations. Finally the lowest brain frequency is the «delta» wave state (equivalent to sleep) which also has importance in learning but will not be covered here. Christopher Bergland is a retired ultra-endurance athlete turned science writer, public health advocate, and promoter of cerebellum («little brain») optimization.