The studies contain limited numbers of exposed pregnancies and for the studies that suggest an increased risk it is considered that the results may be affected by confounding. Clinical studies examining the effect of polytherapy are more limited and are restricted to data from the UK Epilepsy and Pregnancy Registry and the Australian Pregnancy Registry, involving more than 300 exposed pregnancies. Non-clinical studies in the published scientific literature in rodents showed neurodegenerative changes in the cerebral cortex and hippocampus of fetuses exposed to gabapentin during early and mid-pregnancy (Prakash et al 2008 and Badawy et al 2019). However, limitations in the design of these studies make them insufficient to determine the effects of gabapentin on the developing nervous system. An unpublished Good Laboratory Practice compliant study in pregnant rats showed non-dose-related behavioural changes in the performance of the offspring during tests of activity and emotionality but the changes were not statistically significantly different from those of the control animals. Overall, the non-clinical data does not provide clear evidence that exposure to gabapentin during pregnancy adversely affects the development of the central nervous system.

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It’s what happens if you live close to a hospital and start to blank out the sound of sirens, for example. It’s important because it means that organisms don’t waste time and energy by responding to stimuli that do not pose a danger to them. The cerebellum is a leaf-shaped structure found towards the back of the brain. Things like learning to ride a bike or the movement involved in writing will involve a large input from the cerebellum. Below the cerebrum is a structure called the hypothalamus, which is involved in homeostatic responses such as maintaining body temperature (thermoregulation). It also produces hormones that control the pituitary gland, which is found just beneath the hypothalamus.

• 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.
• These studies include low numbers of oxcarbazepine exposed pregnancies – less than 50 pregnancies exposed to monotherapy in the first trimester.
• Gradual loss of structure or function of nerve cells in the brain (neurons), including death of the nerve cells.
• Each “intelligence” can be thought of as a separate “microprocessor” inside our head.

A drug used to treat epilepsy, mainly by controlling or managing the occurrence of seizures in a patient with epilepsy. An absence seizure, which used to be called a “petit mal” seizure, is where the person loses awareness of their surroundings for a short time. Pregabalin (brand name Lyrica) is indicated as adjunctive therapy in adults with partial seizures with or without secondary generalisation. It is also indicated in adults for the treatment of peripheral and central neuropathic pain and the treatment of generalised anxiety disorder (GAD).

First, the brain has constraints on how much information can be processed simultaneously, and when the Body-Mind is on full alert (e.g. flight, fright or fight) the functioning of the lower (reptilian) brain and mid (mammalian) brain take precedence. This means that as the amount of “stress” in the moment increases so more of our thinking is suppressed. This happens probably because, in evolutionary terms, it was more important when being chased by the dinosaur to operate on cerebrumiq “automatic response” mode, than to spend time thinking about it. Of course, today, the stress generated by a situation is not indicative of an immediate threat to life and limb and it is better often to think a solution (using alpha and theta states) than to fire-fight it. We can, in fact, learn to stay calm in volatile or distressing circumstances in which case we retain full ability to use the complete range of logical or intuitive power. When we “have a go” at something new, we step to the edge of our existing frame of reference and we take risks (for example of looking foolish) and we may “fail”.

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 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.

As they tire, their visual processing capacity can rapidly and markedly diminish, in severe cases leaving the person functionally blind. This is not just visual fatigue, but is something we believe needs more research and understanding. StimmingStimming is short for self-stimulating behaviour, and is commonly seen in autistic people who may repeatedly make the same movement, like waving a hand or tapping something over and over. The cause is not known, the purpose is not known, and whether the person has any control over the behaviour is not known. This means the view that it is a ‘self-stimulation behaviour’ is not correct, and for this reason the term ‘stimming’ is not widely used. It is an observation of repetitive body movements, that is all we really know at present, although there are many theories.

The data for diazepam, fosphenytoin, lorazepam, midazolam, thiopental sodium and stiripentol have not been reviewed given that the authorised indications for these antiepileptic drugs include status epilepticus, acute convulsions, refractory convulsive disorders or Dravet’s syndrome. For completeness, clinical data in relation to a number of other antiepileptic drugs less commonly used in the UK has also been reviewed; these include brivaracetam, clobazam, clonazepam, eslicarbazepine, ethosuximide, lacosamide, perampanel, primidone, rufinamide, tiagabine and vigabatrin. The restrictions to the use of valproate in girls or women followed a review of the available safety data including studies in animals and women who are pregnant.

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Other clinical studies by Veiby et al 2014 and Mostacci et al 2017 contain less than 30 pregnancies exposed to pregabalin in the first trimester and provide very little data to inform our understanding. Emerging unpublished data from a clinical study provide some suggestion of a slight increased overall risk of congenital malformations. However, at the time of publication of this report the study data are currently undergoing further evaluation at a European level.

National Institute for Health and Care Excellence

Epilepsy is a long-term condition and so people can be on medicines for a long time. Understandably there are many concerns that a woman will have when she begins to plan a pregnancy. These include how her epilepsy might affect her chance of becoming pregnant, how the pregnancy might affect her epilepsy, and also how her epilepsy medicine(s) may affect her unborn baby. In drug development, preclinical development, also named preclinical studies and non-clinical studies, is a stage of research that begins before clinical trials (testing in humans) can begin, and during which important feasibility, iterative testing and drug safety data are collected. Used interchangeably with the term ‘pre-clinical studies’ within this report. The available non-clinical data are very limited and focus on an identified neuroprotective property of zonisamide in different settings, such as during ischaemic damage.