A study that involves looking at data from a population at one specific point in time. This type of study can be used to describe the characteristics that exist in a population and gather preliminary data to support further research but cannot be used to determine cause and effect. ADHD is a mental health condition that is defined through analysis of behaviour. People with ADHD show a persistent pattern of inattention and/or hyperactivity–impulsivity that interferes with day-to-day functioning and/or development. Singh M, Mishra A. Prenatal topiramate exposure induced developmental changes in rat brain. For both clobazam and clonazepam, there are data on approximately 300 and 1,000 exposed pregnancies respectively; however, this is still a relatively moderate number and the findings are inconsistent.

However, the number of exposures in the available clinical studies remains very limited and suggests that this is an area where further study would be very important. For the outcome of autism spectrum disorders, the data for lamotrigine were not completely consistent, with some studies reporting increases in the risk of autism spectrum disorders and similar outcomes, but with different estimates of the size of the increase. The prevalence of major congenital malformations varies between 1.17% and 8% in the studies, likely reflecting the different study methodologies and populations studied. However, they generally appear to support a prevalence of around 4–5% and a risk of major congenital malformations following in-utero exposure to carbamazepine monotherapy that is higher than in the general population (2–3%) and higher than that seen in women with epilepsy who are untreated. Congenital malformations reported include cleft lip or palate, cardiac malformations, neural tube defects, hypospadias, genitourinary tract defects, skeletal malformations including club foot and polydactyly and respiratory and gastrointestinal malformations.

Epilepsy medicines and the risks to the unborn baby

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.

A group of disorders in which the development of the central nervous system is disturbed. The disorders can affect emotion, learning ability, self-control and memory. They can also manifest as conditions such as attention deficit hyperactivity disorder or autism spectrum disorder. NICE guidance recommends that pregabalin may be considered by the tertiary epilepsy specialist in the treatment of focal seizures if adjunctive treatment is not effective or not tolerated. Therefore, its use in epilepsy is likely limited and the product information reflects that the available data on pregnancy outcomes is also limited. A regulatory-compliant company-sponsored study in pregnant rats reported an increased incidence of fetal malformations at human therapeutic doses (approximately 1.2 to 4 times the maximum human recommended dose).

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The increased malformations observed in mice occurred at plasma concentrations relevant to the human therapeutic dose. Therefore, based on the currently available non-clinical data the risk of a teratogenic effect following therapeutic use in humans cannot be excluded. Based on the pooled data from this study the prevalence of major malformations (any type) for children exposed to zonisamide was calculated to be 0.28% (95% CI 0.25–2.39) in the meta-analysis by Weston et al 2016. The preliminary conclusion from review of emerging unpublished clinical data is that there was no evidence of an increased risk for attention deficit hyperactivity disorder, autism spectrum disorders and learning disabilities in pregabalin-exposed children. The findings from clinical studies with regards to the risk of fetal death in association with in-utero exposure to oxcarbazepine are inconsistent.

• However, these studies suffer from some limitations that preclude firm conclusions being reached.
• The available clinical data on the risk of neurodevelopmental disorders with levetiracetam is extremely limited and involves data on around 100 children (Shallcross et al 2011, Bech et al 2018, Huber-Mollema et al 2019 and 2020).
• 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.

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.

Prescription cost analysis data show that 164,243 prescription items for zonisamide were dispensed in England in cerebrumiq 2019 and data from the CPRD suggest that its use in women of childbearing age is limited. Where clinical studies have examined a dose-response, the findings are mixed; the larger studies are more supportive of an increased risk with increasing doses of carbamazepine (Tomson et al 2018, UKEPR) but other smaller studies are not (Hernandez Diaz et al 2012, Samren et al 1997). The possibility of a dose-dependent risk is already reflected in the carbamazepine Summary of Product Characteristics.