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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