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Pregabalin safety update on pregnancy risks issued

Patient leaflet available

April 25th 2022

Tagged: MHRA alert



Pregabalin may slightly increase the risk of major congenital malformations if used in pregnancy, the MHRA has announced. It has produced an information leaflet on pregabalin and risks in pregnancy for patients taking pregabalin who are able to become pregnant.

The MHRA says that patients using pregabalin should be counselled accordingly about the potential risks to an unborn baby, and the need to use contraception during treatment.

Pregabalin should be avoided during pregnancy “unless clearly necessary and only if the benefit to the patient clearly outweighs the potential risk to the foetus.” This requires ensuring the patient has a full understanding of the benefits, risks, and alternatives, and is part of the decision-making process.

The announcement follows data from an observational study of more than 2,700 pregnancies exposed to pregabalin. This has “shown use in the first trimester to be associated with a slightly increased risk of major congenital malformations compared with exposure to no antiepileptic drugs or to lamotrigine or to duloxetine.”