Pregabalin May Slightly Increase the Risk of Major Congenital Malformations

The Medicines and Healthcare products Regulatory Agency (MHRA) has issued a drug safety update on the use of pregabalin in pregnancy, following a new study suggesting 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”.

Pregabalin was first approved by the European Medicines Agency (EMA) in July 2004 for the treatment of peripheral neuropathic pain and as adjunctive therapy for adult patients with partial onset seizures. The marketing authorisations were expanded in 2006 to include generalised anxiety disorder and central neuropathic pain.

A review of the safety of antiepileptic drugs in pregnancy published in January 2021 had noted that due to conflicting data, no firm conclusions could be drawn on the potential teratogenic effects of pregabalin. At the time, the product information noted that the potential risk for humans in pregnancy was unknown. EU labelling stated that the drug “should not be used during pregnancy unless clearly necessary (if the benefit to the mother clearly outweighs the potential risk to the foetus)”.

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