Antipsychotic use in pregnancy and congenital malformation risk

Researchers from Aarhus University in Denmark have published an updated analysis of linked data collected from Danish population-based healthcare registers, investigating major malformation risks among pregnancies exposed to antipsychotics in the first trimester in comparison with unexposed pregnancies. Robust sensitivity analyses were also conducted, including comparisons formed between exposed pregnancies, and pregnancies among women who only used antipsychotics prior to […]

» Read more

ConcePTION Webinar Invite: Using real word data for research on medication safety during pregnancy and breastfeeding

On 20 April 2023, 1400-1500 CEST, experts from Work Package 7 of the ConcePTION project will present a discussion of the opportunities and challenges of using real-world data to study medicine safety during pregnancy and breastfeeding. You can register to join this free and open-access webinar to learn more about how real-world data can inform clinical and regulatory decision-making, and […]

» Read more

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.

» Read more

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 […]

» Read more

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

» Read more

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 […]

» Read more
1 3 4 5 6 7 23