Observational study of newer anti-seizure medication use in pregnancy; focus on lacosamide

Researchers and ENTIS members from the Embryotox Center of Clinical Teratology and Drug Safety in Pregnancy, in Berlin, have published an observational study of newer anti-seizure medication use in pregnancy. The study has a focus on lacosamide, describing 55 prospective and 10 retrospective exposures. More information is available here, where the paper is openly available until 19th May 2023.

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IMI ConcePTION recommendations published on the data fields needed for pregnancy pharmacovigilance

Researchers from the Innovative Medicines Initiative (IMI) ConcePTION project have published a set of recommendations about the core data elements which should be collected when performing studies of medication use in pregnancy. These recommendations include all the key variables that are required in studies assessing both immediate pregnancy/infant outcomes, and longer-term childhood outcomes following maternal medication use in pregnancy. Each […]

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Study of adverse pregnancy outcome risks following treatment of CMV with ganciclovir or valganciclovir

Researchers with access to the VigiBase database of adverse drug reactions have conducted a disproportionality analysis of adverse pregnancy outcomes to identify safety signals associated with ganciclovir or valganciclovir use in pregnancy. More information can be found here. The authors of the study have also provided ENTIS with a visual abstract of their study: Photo by Wengang Zhai on Unsplash

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Neurodevelopmental outcome of children exposed to pravastatin in utero

Researchers from the Eunice Kennedy Shriver National Institute of Child Health and Human Development-Obstetrics Fetal Pharmacology Research Centers Network have conducted a long-term follow-up study to determine the impact pravastatin treatment in pregnant women at high risk of preeclampsia may have on child health, growth, and neurodevelopment. The results of this small study, although limited by the trial’s sample size […]

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ConcePTION Project: Communication toolkit launch – 15th March

Communication experts from the IMI ConcePTION project have produced a toolkit will allow organisations with limited resources to design communication campaigns to stimulate reporting of medicine use during pregnancy and breastfeeding to appropriate organisations. ENTIS members are invited to join the online launch of this toolkit on 15th March, 1500-1600 Central European Time (CET). For more information about the toolkit, […]

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Limited evidence of a link between acetaminophen (paracetamol) and autism or ADHD

FactCheck.org have published an article on the interpretation of the available evidence surrounding autism and ADHD risks in children exposed to acetaminophen (paracetamol) in utero. The article concludes that there is currently no strong evidence that acetaminophen use during pregnancy causes autism or ADHD in children, and that experts continue to recommend use of the drug during pregnancy when necessary […]

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