Category: ENTIS News

Researchers affiliated to the ENTIS network, led by Professor Hedvig Nordeng (University of Oslo) and Dr Michael Ceulemans (KU Leuven and Teratology Information Service Lareb), have published the results of a pan-European online questionnaire investigating pregnancy and birth related experiences of women during the third wave of the COVID-19 pandemic. More information can be found here. Photo by Alexander Grey […]

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Chair of the ENTIS Scientific Committee, Prof Per Damkier, and the Head of UKTIS, Dr Ken Hodson, have published an opinion piece in the Obstetric Medicine journal challenging the findings of a 2021 consensus statement published in Nature Reviews Endocrinology. More information can be found here. Photo by James Yarema on Unsplash

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In March 2022 the European Medicines Agency’s (EMA) published a direct healthcare professional communication (DHPC) regarding the use of live vaccines in infants exposed to infliximab in utero or during breastfeeding. The DHPC stated that live vaccines (e.g. BCG vaccine) should not be given to infants less than 12 months after birth following in utero infliximab exposure, and that administration […]

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ENTIS affiliated researchers from the Department of Pharmaceutical and Pharmacological Sciences, KU Leuven have published a case report of bosentan and sildenafil use in lactation. This report, from the IMI ConcePTION project, presents the clinical and pharmacokinetic data of a single mother-infant pair exposed to bosentan and sildenafil for the treatment of pulmonary arterial hypertension (PAH) during lactation. More information […]

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The ENTIS Board and Scientific Committee have submitted an official communication to the EMA Pharmacovigilance and Risk Assessment Committee (PRAC) to highlight their concerns with recent updates to the Lyrica SmPC. The submitted letter can be read here. Photo by Scott Graham on Unsplash

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ENTIS affiliate member Dr Michael Ceulemans and colleagues from the Department of Pharmaceutical and Pharmacological Sciences at KU Leuven, Belgium, have published their informative results from a qualitative study investigating the experiences and perspectives of pharmacovigilance specialists at Marketing Authorisation Holders (pharmaceutical companies) towards the safety monitoring of medication exposures in pregnancy. More information can be found here. Photo by Antenna on Unsplash

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