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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