The Therapeutic Goods Administration (TGA) has issued a Medicines Safety Update on the use of pregabalin during pregnancy. The pregnancy risk category for pregabalin has changed from Category B3 to Category D, and product information documents are being updated to strengthen the advice against prescribing pregabalin during pregnancy.

This update is based on the findings of an observational study investigating the safety of pregabalin in the first trimester of pregnancy. Data were obtained from population-based registries in Denmark, Finland, Norway, and Sweden. The incidence of major congenital malformations, birth outcomes, and selected neurodevelopmental outcomes was evaluated for babies exposed to pregabalin in utero. These outcomes were compared to babies exposed to lamotrigine (chosen as an alternative antiepileptic drug), duloxetine (alternative for neuropathic pain and generalised anxiety disorder), and none of these medicines.

The data showed a higher prevalence of major congenital malformations in babies exposed to pregabalin compared with those not exposed to pregabalin or any other antiepileptic drug (crude percentage 5.9% versus 4.1%). However, the adjusted prevalence ratio in the final meta-analysis was not statistically significant (1.13 [95% CI 0.97-1.31]).

The study authors note that their results do not provide strong evidence of human teratogenicity, although a small increased risk cannot be ruled out. The TGA advises that pregabalin should only be prescribed to pregnant women if the benefits clearly outweigh the potential risks.


  1. Department of Health and Aged Care. Medicines Safety Update: Avoid prescribing pregabalin in pregnancy if possible. Woden: Therapeutic Goods Administration; 2023.
  2. Richardson JL, Damkier P, Diav-Citrin O, George N, Greenall AJ, Oliver AM, et al. A critical appraisal of controlled studies investigating malformation risks following pregabalin use in early pregnancy. Br J Clin Pharmacol. 2023; 89(2): 630-40.
  3. Toft G, Ehrenstein V, Asomaning K. A population-based cohort study of pregabalin to characterize pregnancy outcomes. 2020.
  4. Wise J. Avoid prescribing pregabalin during pregnancy if possible, says UK drug regulator. BMJ. 2022; 377: o1010.

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