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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Zika virus, a new infectious teratogen? Alarming observations from Brazil

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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