ENTIS official response to the EMA recommendations concerning ondansetron use by pregnant women

On the 18th September 2019, ENTIS issued an official response to the European Medicines Agency (EMA) Pharmacovigilance Risk Assessement Committee (PRAC) concerning the recommendations which were made about ondansetron use by pregnant women, as detailed in the minutes of their meeting held from the 8th to 11th July. The official ENTIS response statement can be read here.

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Most common birth defects among the infants of women with diabetes in pregnancy

A collaboration of researchers from the Centers for Disease Control and Prevention’s National Center on Birth Defects and Developmental Disabilities, the University of Texas, Emory Univeristy and the University of Utah have published an analysis of data collected by the National Birth Defects Prevention Study (1997-2011) to describe the defects most commonly observed among the infants of women with pregestational […]

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Consensus statement on the management of individuals with fetal valproate spectrum disorder

The European Referece Network for Congenital Malformations and Intellectual Disability have conducted a review of published and unpublished evidence relating to the diagnosis and management of fetal valproate spectrum disorder, and subsequently issued management recommendations based on the evidence from their review in combination with expert and patient opinion. More information can be found here. Photo by Samuel Zeller on […]

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Study of male genital anomalies following maternal oral contraceptive use in pregnancy

A collaboration of researchers from Aarhus University and the University of Copenhagen have performed an analysis of the Danish National Birth Cohort to investigate the risk of cryptorchidism (undescended testicles) and hypospadias (abnormal positioning of the urethral opening) following the maternal use of oral contraceptives. More information can be found here. Image by mmmCCC from Pixabay

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Literature review: Risk of adverse fetal effects following short-term second trimester NSAID use

Researchers from Embryotox, the Berlin TIS, have recently published the results of their systematic review focussing on the risk of prenatal ductus arteriosus constriction, oligohydramnios, neonatal renal failure and primary pulmonary hypertension following maternal short-term use of NSAIDs in the second trimester of pregnancy. More information can be found here.

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