Congenital malformation risks following integrase inhibitor use in pregnancy

Utilising data from the Colorado-based Children’s Hospital Immunodeficiency Program (CHIP), a team of researchers have published a retrospective comparative cohort study of pregnancy and fetal outcomes following first trimester integrase inhibitor use (dolutegravir, elvitegravir or raltegravir). The study describes increased risks of congenital anomalies among the first trimester integrase inhibitor exposed in comparison with those born to women with HIV […]

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Expert consensus published focusing on the study of neurodevelopmental outcomes in pregnancy drug safety studies

Experts from 13 countries and professionally diverse backgrounds took part in the development of a series of recommendations focusing on the importance of including the study of infant neurodevelopment as a core feature of pregnancy drug safety studies. These recommendations outline the core neurodevelopmental outcomes, optimization of methodological approaches and barriers to conducting pregnancy drug safety studies including neurodevelopmental outcomes. […]

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Cardiac malformation risk following first trimester methylphenidate use in pregnancy

Researchers from the UK Teratology Information Service have published an updated meta-analysis of studies investigating the risk of cardiac malformation following maternal first trimester methylphenidate use in pregnancy. The findings indicated a small statistically significant increased risk, but the authors advised caution in the interpretation of this finding given that the primary source studies are likely confounded. The brief report […]

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Comment on the latest meta-analysis investigating childhood neurodevelopment outcomes following acetaminophen (paracetamol) use in pregnancy

Professor Per Damkier (University of Southern Denmark), Chair of the ENTIS Scientific committee, has provided a comment on the most recent meta-analysis investigating in utero exposure to acetaminophen and childhood neurodevelopment (Ricci et al., 2023). In this comment, published in Paediatric and Perinatal Epidemiology, Prof Damkier highlights important key methodological limitations and notable conflicting findings in the primary source literature. […]

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In utero antiseizure medication exposure and the risk of psychiatric disorders

A collaborative of Scandinavian researchers led from Aarhus University in Denmark have published a large prospective, population-based register study including over 4.5 million study subjects which investigated the risk of psychiatric disorders following in utero ASM exposure. The study findings indicate that n utero valproate, topiramate and levetiracetam exposure may be associated with increased risks of neurodevelopmental impairment, ADHD and/or […]

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