A critical appraisal of the malformation risks following pregabalin use in early pregnancy

ENTIS affiliated researchers from the UK, Denmark and Israel have published a literature review and critical appraisal which explores whether recent SmPC updates applied to some pregabalin products are justified, and provides clarity on the risk-benefit balance for pregabalin use in early pregnancy. This publication was developed after the ENTIS Board and Scientific Committee submitted an official communication to the EMA Pharmacovigilance and Risk Assessment Committee (PRAC) to highlight their concerns with recent updates to the Lyrica SmPC. More information about the literature review and critical appraisal can be found here.

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