This further information can be collected by a number of means including through spontaneous reporting schemes such as the Yellow Card Scheme in the UK, population-based birth registries of children born with congenital malformations, pregnancy registries and observational studies. The data from the birth registries, pregnancy registries and observational studies are used to determine the association of exposure to antiepileptic drugs during pregnancy and adverse outcomes in infants and children. To support informed decision-making, in July 2019 the Commission on Human Medicines (CHM) endorsed a proposal for a review of data from non-clinical and clinical studies relating to the safety of non-valproate antiepileptic drugs during pregnancy.<\/p>\n
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Although the risk was statistically significantly increased compared to the untreated control group, there was no difference compared with a levetiracetam exposed group and the available data for the latter does not appear to support an increased risk of fetal loss. Non-clinical studies in pregnant rats, rabbits, and mice report that exposure during pregnancy resulted in fetal malformations and these occur at plasma concentrations relevant to human therapeutic doses. The defects observed in animals are similar to those seen with fetal hydantoin syndrome. For topiramate, more recent data suggests the possibility of poorer development outcomes for children exposed during pregnancy and the possibility of a higher incidence of autistic spectrum disorder in children exposed to topiramate.<\/p>\n
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Multiple Disabilities with a Visual Impairment (MDVI)As with Low Vision and Learning Delay, above, the term MDVI is used to separate those with visual impairments with many needs, from those more able. The term is also used to separate those with multiple disabilities with a visual impairment, from those with multiple disabilities but do not have a visual impairment. The term multiple disabilities may be mistakenly understood to mean multiple medical conditions, which may be the case, but the term is typically used to describe a person with a combination of medical and learning \/ developmental challenges.<\/p>\n
The number of exposures in the available clinical studies remains very limited and this is an area where further study would be very important. Overall, very few clinical studies have examined the risk of major congenital malformations in pregnancies exposed to zonisamide and the number of pregnancies exposed to monotherapy is very small (less than 100 pregnancies). Further clinical data are available from a small retrospective questionnaire-based study conducted in Japan cerebrumiq<\/a> (Kondo et al 1996) and the Swedish Medical Birth Register (K\u00e4ll\u00e9n et al., 2013). The study by Kondo et al reported on the outcomes of 26 pregnancies, of which only 4 were pregnancies exposed to zonisamide monotherapy.<\/p>\n 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\u2019s 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.<\/p>\n When this happens, the true link between exposure and outcome is distorted. People may be placed in the wrong groups for different reasons including because of incomplete medical records, recording errors in medical records, or misinterpretation of records. Studies which assess trends in the occurrence, distribution or control of diseases or medical conditions in defined populations. A rare birth defect in where the baby\u2019s skull doesn\u2019t grow properly and their head becomes an unusual shape. A medical condition that is acquired by the fetus during pregnancy and is present at birth.<\/p>\n\n
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