A multi-centre observational study of vedolizumab use in pregnancy has been published in the Journal of Crohn’s and Colitis which provides a small amount of additional safety information. Photo by John Looy on Unsplash
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A collaborative of researchers from the University of York, AbbVie Biopharmaceuticals and the University of Pennsylvania have published an interesting feasibility study into the use of social media data for the purposes of pregnancy pharmacovigilance in Drug Safety. Photo by William Iven on Unsplash
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Researchers from the University of Montreal have published a methodological paper describing analytical techniques which may be useful for assessing the extent and impact of selection bias which may arise as a consequence of delayed cohort inclusion. The study demonstrates three analytical approaches utilising a regional administrative dataset; full details are published in Pharmacology Research and Perspectives. Photo by freestocks.org on Unsplash
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US National Birth Defects Study data has been analysed to investigate malformation risks following maternal antihypertensive medication use in pregnancy. Although the authors report some statistically significant associations with specific anomalies, these findings were not related to any particular class of medications. Furthermore, associations were seemingly based on small numbers of exposed and affected infants, and the impact of the […]
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A collaboration of researchers from the Netherlands Pharmacovigilance Centre (Lareb), Radboud University Medical Centre and the University of Groningen, have published details of their national pregnancy and medication exposure register pREGnant in Drug Safety. Photo by Ian on Unsplash
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Collaborators from the International Clearinghouse for Birth Defects Surveillance and Research have published an interesting commentary on the value of data sharing and networking between birth defects surveillance programs in the Journal of Community Genetics. Photo by Kelsey Knight on Unsplash
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A collaborative ENTIS study recently published in Reproductive Toxicology (Volume 67, Pages 26-34) has provided no signal that varenicline is a major human teratogen. This collaborative ENTIS study was undertaken by researchers based at teratology information services in the United Kingdom, Israel, France (Paris), Germany (Berlin), Australia, the Netherlands, Finland and Turkey (Izmir), who collectively joined data from over 400 […]
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In August 2016 JAMA Psychiatry published the results of a large pharmacoepidemiological cohort study by Krista Huybrechts et al., examining the risk for congenital malformations overall as well as cardiac malformations associated with first-trimester exposure to antipsychotics. While previous studies documented the outcome of several hundred exposed pregnancies at most, this study cohort included a nationwide sample of more than […]
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Changing of the Guards: EMA Warning on Paternal Use of Mycophenolate Mofetil: An Unnecessary and Insufficiently Substantiated Precaution. Damkier P, Passier A, Petersen LB, Havnen G, Petersen AJT. Birth Defects Res A Clin Mol Teratol. 2016 Sep 28. doi: 10.1002/bdra.23556 In this commentary, we strongly argue against the changes to the Summary of Product Characteristics (SmPC) made by European Medicines […]
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Zika virus and microcephaly in Brazil The Zika virus epidemic started in Brazil in May 2015, and by end of November more than 1,200 cases of microcephaly have been reported in Brazil during 2015, reaching a prevalence of 99.7:100,000 in live born infants, compared to the background annual prevalence of 5.5:100,000. The Zika virus disease is a mosquito-borne (Aedes species) […]
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