Pregabalin may slightly increase risk of major congenital malformations

20 April 2022: The Medicines and Healthcare products Regulatory Agency (MHRA) has issued a drug safety update on the use of pregabalin in pregnancy, after a new study suggests that it may slightly increase the risk of major congenital malformations.

Advice for healthcare professionals is that potentially fertile women should continue to use effective contraception during treatment with pregabalin, and that use of the drug in pregnancy should be avoided unless it is “clearly necessary”.

The latest alert was prompted by the pregabalin pregnancy outcomes study, an observational cohort study in Denmark, Finland, Norway, and Sweden that included over 2700 pregnancies with pregabalin exposure during the first trimester, the largest population-based study to date. 

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