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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Publication of recent study of pregnancy outcome after methylphenidate exposure

A collaborative study published in J Clin Psychiatry by ENTIS and MotherToBaby affiliated researchers did not suggest that first trimester in utero exposure be associated with increased risk of congenital malformations.   Methylphenidate is a central nervous system stimulant medicinally used in the treatment of attention deficit disorders. Data on its safety in human pregnancy are sparse. A recent prospective, comparative, […]

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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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Recent ENTIS study investigates the pregnancy outcomes after pregabalin exposure

A collaborative ENTIS study published in Neurology found an increased frequency of major malformations following exposure to pregabalin during the first trimester of pregnancy. Eight member centers of the European Network for Teratovigilance Information Services (ENTIS) conducted a study, which aimed at recording the incidence of malformations after pregabalin use during the first trimester of pregnancy [1]. Pregabalin, an anti-seizure drug, is […]

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