Malformation risk of new anti-epileptic drugs in women with epilepsy; observational data from the Kerala registry of epilepsy and pregnancy (KREP)

Thomas, Sanjeev V; Jeemon, Panniyammakal; Pillai, Rajit; Jose, Manna; Lalithakumari, Arya M; Murali, Sruthy; Sanalkumar, Arjun; Salini, Reshma A; Pavithran, Veena

doi:10.1016/j.seizure.2021.10.015

Cited by 15 publications

(13 citation statements)

References 21 publications

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“…1). [33][34][35][36][37][38][39][40] When considering the results of each of the pregnancy registries (►Table 3) and in turn making comparisons, it is important to remember each registry study has its own strengths and weaknesses (►Table 4). 41 The key concerns are possible enrolment bias and representativeness of real life, but other concerns include nonstandardized data collection across different studies (epilepsy cause, epilepsy syndrome, seizure types); lack of drug concentration measurements as part of the protocols; certain confounders not being assessed; and different approaches to determining outcomes in nonblinded studies.…”

Section: Global Pregnancy Registries and Post-marketing Surveillancementioning

confidence: 99%

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Preventing Teratogenicity in Women with Epilepsy

2022

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Over the last 50 years there has been a significant increase in our understanding of the issues faced by women with epilepsy, in both planning and undertaking pregnancy. The risks of teratogenicity associated with antiseizure medications have emerged slowly. The major pregnancy registers have substantially contributed to our knowledge about teratogenic risk associated with the commonly used antiseizure medications. However, there are substantial gaps in our knowledge about the potential risks associated with many third-generation drugs. The remit of the pregnancy registers and the wider research focus has moved beyond anatomical major congenital malformations. Increasingly neurodevelopmental and behavioral abnormalities have been investigated after in utero exposure to antiseizure medications. Public health approaches can help reduce the risk of teratogenicity. However, neurologists still have a vital role in reducing the risk of teratogenicity at an individual level for women attending their clinic. They also have responsibility to ensure that women with epilepsy are aware of the rationale for the different available options.

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Section: Global Pregnancy Registries and Post-marketing Surveillancementioning

confidence: 99%

“…No studies have looked at dose response. Since the 2016 meta-analysis, the Kerala registry 40 published a concerning signal of possible MCM risk.…”

Section: Monotherapymentioning

confidence: 99%

Preventing Teratogenicity in Women with Epilepsy

2022

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“…Valproate and carbamazepine have been independently associated with development of neural tube defects such as spina bifida, with prevalence of spina bifida with valproate estimated at 1–2%, 10–20 times the baseline rate, and 0.5% with carbamazepine [20]. Polytherapy, particularly with valproate, also had a significantly increased risk of overall MCM [1 ▪▪ ,4,19 ▪ ,21 ▪ ]. Due to significant risks with valproate, this should be avoided in pregnancy if possible.…”

Section: Anti-seizure Medications During Pregnancymentioning

confidence: 99%

Contemporary management of epilepsy in pregnancy

Darmawan¹,

Panelli

2022

Current Opinion in Obstetrics &Amp; Gynecology

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Purpose of reviewThe number of reproductive aged people with epilepsy in the United States is increasing, making epilepsy during pregnancy more prevalent. Simultaneously, more people are using newer generations of antiseizure medications before, during and after pregnancy. Here, we review current evidence on contemporary management and outcomes of pregnancies among people with epilepsy. Recent findingsThis review evaluates recent literature to summarize current practices in preconception counselling, contraception, antiseizure medications before, during and after pregnancy, and peri-partum and postpartum risks in people with epilepsy.

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“…In this study, multiscale modeling methods are being used at the molecular level to assist in excipient design, which is primarily based on the drug and polymeric excipient materials' hydrogen bonds and their strength and content. The antiepileptic medication phenytoin (PNT), whose chemical structure is depicted in Figure 1, 27 was chosen as the hydrophobic drug for this study. The drug molecule contains cyclic amide groups, which are prone to form hydrogen bonds that induce crystallization without the addition of excipients for modification.…”

Section: Introductionmentioning

confidence: 99%

Hydrogen Bonding Principle-Based Molecular Design of a Polymer Excipient and Impacts on Hydrophobic Drug Properties: Molecular Simulation and Experiment

et al. 2023

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Although some commercial excipients for improving the solubility of highly crystalline drugs are widely used, they still cannot cover all types of hydrophobic drugs. In this regard, with phenytoin as the target drug, related molecular structures of polymer excipients were designed. The optimal repeating units of NiPAm and HEAm were screened out through quantum mechanical simulation and Monte Carlo simulation methods, and the copolymerization ratio was also determined. Using molecular dynamics simulation technology, it was confirmed that the dispersibility and intermolecular hydrogen bonds of phenytoin in the designed copolymer were better than those in the commercial PVP materials. At the same time, the designed copolymers and solid dispersions were also prepared during the experiment, and the improvement of their solubility was confirmed, which is in accordance with the simulation predictions. The new ideas and simulation technology may be used for drug modification and development.

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Malformation risk of new anti-epileptic drugs in women with epilepsy; observational data from the Kerala registry of epilepsy and pregnancy (KREP)

Cited by 15 publications

References 21 publications

Preventing Teratogenicity in Women with Epilepsy

Preventing Teratogenicity in Women with Epilepsy

Contemporary management of epilepsy in pregnancy

Hydrogen Bonding Principle-Based Molecular Design of a Polymer Excipient and Impacts on Hydrophobic Drug Properties: Molecular Simulation and Experiment

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