Abstract: Objective: Benzodiazepines (BDZs) safety profiles in pregnancy suggest that the risk of major malformations (MMs) cannot be considered simply as a “class effect”. The aim of this paper was to review and update the available literature on the risks of MMs in women exposed to BDZs in the first trimester of pregnancy.Methods: PubMed was searched for English-language articles, from January 2001 to November 2011, introducing as keywords “teratogens”, “ major malformation”, “foetus”, “infant”, “newborn”, “pregnancy”, in conjunction with “benzodiazepines” as a keyword or BDZ generic name as text words.Results: Twelve studies were selected for the review.

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