Methods for assessing selection bias in pregnancy pharmacovigilance studies

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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Birth defect risks following maternal antihypertensive use

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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Collaborative ENTIS study into the risk of adverse pregnancy outcomes following maternal varenicline use

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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Antipsychotics in Pregnancy: Large Cohort Study from the US Investigates Risk for Congenital Malformations

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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Recent letter by ENTIS members question the EMA warning on Paternal Use of Mycophenolate Mofetil

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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