A new study has suggested pregabalin may slightly increase the risk of major congenital malformations if used in pregnancy

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An observational study of more than 2700 pregnancies exposed to pregabalin has shown use in the first trimester to be associated with a slightly increased risk of major congenital malformations, compared to exposure to no antiepileptic drugs, lamotrigine, or duloxetine.

Pregabalin (brand names Alzain, Axalid, Lecaent, Lyrica, plus generic versions) is indicated for the treatment of peripheral and central neuropathic pain in adults, as adjunctive therapy in adults with partial seizures with or without secondary generalisation, and for generalised anxiety disorder in adults.

The new study showed a higher prevalence of major congenital malformations in babies (live or stillborn) exposed to pregabalin in the first trimester of pregnancy (crude percentage 5.9%) compared with those not exposed to pregabalin or any other antiepileptic drug (crude percentage 4.1%).

After adjustment, the risk of major congenital malformations was slightly higher but not statistically significant with pregabalin monotherapy use in the first trimester versus the comparison group (adjusted prevalence ratio 1.14 [95% confidence interval] 0.96 to 1.35).

The data suggested modest but statistically significantly increased risks (less than two-times) of major congenital malformations in pregnancies exposed to pregabalin, compared with pregnancies exposed to lamotrigine or duloxetine.

Folllowing these findings, healthcare professionals are advised to:

  • continue to provide counselling to patients using pregabalin on the potential risks to an unborn baby and the need to use effective contraception during treatment
  • continue to avoid use of pregabalin during pregnancy unless clearly necessary and only if the benefit to the patient clearly outweighs the potential risk to the fetus
  • advise patients planning a pregnancy or who become pregnant during treatment to make an appointment to discuss their health condition and any medicines they are taking.

In cases where the benefit outweighs the risk, and it is clearly necessary that pregabalin should be used during pregnancy, it is recommended to use the lowest effective dose and report any suspected adverse drug reactions, including for the baby, via the Yellow Card scheme.

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