Visual spatial skills help individuals find their orientation in space through taking in information from the world around them and organizing that visual information to create an understanding of meaningful patterns. It is one of a number of cognitive functions that also include perception, attention, memory, motor skills and language. These are population-based registers that collect data from medical records about the prenatal, delivery and neonatal care of pregnant women and their offspring. Such registers support the monitoring of the health of pregnant women and their offspring and are used for research purposes.

Intelligence Quotient (IQ)

That means around 1 in every 100 people in the UK has seizures or needs epilepsy medicines. In our public assessment reports, we discuss evidence-based reviews of safety issues linked with a particular medicine or group of medicines. The Medicines and Healthcare products Regulatory Agency (MHRA) is the government agency responsible for regulating medicines and medical devices in the UK and ensuring their safety, quality and effectiveness. We continually review the safety of all medicines in the UK and inform healthcare professionals and the public of the latest updates.

• Studies which assess trends in the occurrence, distribution or control of diseases or medical conditions in defined populations.
• 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.
• Dyspraxia, also known as developmental co-ordination disorder (DCD), is a common disorder that affects movement and co-ordination.

Systematic review

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 5–۶%).

Epidemiological studies

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).

Scientists are able to use the database to identify genes and proteins which are implicated in disease. This information can then be used to create new drugs to target those proteins. Genome sequencing has also identified tiny genetic variations between people where just one nucleotide differs – the fancy term for this is single nucleotide polymorphisms (SNPs). Some of these genetic variations are known to make some drugs less effective. This has resulted in a new area of healthcare called personalised medicine where doctors can prescribe a unique treatment plan depending on the genetic variations found in each individual patient.

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 cerebrumiq 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.

• It was whether raw intelligence, as defined by a test, should outweigh empathy, preparation, or communication – the real skills of an effective educator.
• The MHRA will continue to monitor the safety of all medicines, however the information in this report will not be actively updated with new data or studies.
• It is measured in weeks, from the first day of the woman’s last menstrual cycle (period) to the current date.
• Equally there are other prospective studies in pregnancy registries that do not support an increased risk of fetal loss (Bech et al 2014, Vajda et al 2018).