Evaluation of the teratogenic effects of pregabalin usage during pregnancy: A multicenter case-control study

P regabalin is a gabapentinoid that acts by inhibiting calcium channels [1].Binding to the 2 subunit site of the voltage-dependent calcium channels appears to be responsible for its therapeutic effects [2].Pregabalin is used for treatment of epilepsy, neuropathic pain, fibromyalgia, and generalized anxiety disorder as an anticonvulsant and anxiolytic agent [3,4].Off-label uses of pregabalin include social anxiety disorder, bipolar disorder, insomnia, chronic pain conditions and the prophylaxis of chronic migraine.It was approved by the United States Food and Drug Administration in 2004 for painful diabetic neuropathy and postherpetic neuralgia [5].The precise molecular mechanisms underlying the potential teratogenic mechanisms of pregabalin are not fully understood and there is limited research on this area.However, there are some factors that may be responsible for po-ABSTRACT OBJECTIVE: Information regarding pregabalin use is limited.We aimed to assess the outcome of the patients who have taken pregabalin at a certain time during their pregnancies.METHODS: 31 patients used pregabalin treatment during pregnancy and 93 control patients were included in the study who applied to hospital between the years 2013-2022.In this multicenter case-controlled study, the outcome of the pregnancies and the health condition of the newborn in the pregabalin and control groups were evaluated.RESULTS: Preterm delivery rates (5/27 (18.5%) vs. 5/87 (5.7%); OR 0.26, 95% CI 0.07-1.01,p=0.04) and lower birth weight (6/27 (22.2%) vs. 5/81 (6.6%); OR 4.34, 95% CI 1.20-15.65,p=0.016) were found higher in the pregabalin group compared to the control group.However, significant difference was not found between the birth dates of babies in pregabalin and control groups with the log-rank test (p=0.30).Spontaneous abortion rates were not significantly different (2/31 (6.4%) vs. 4/93 (4.3%); OR 1.52, p=0.63).Although major malformation rates in pregabalin were higher than those in controls (3/27 (11%) vs. 4/88 (4.5%); OR 0.38, 95% CI 0.07-1.82,p=0.21) the outcomes were statistically insignificant.CONCLUSION: Preterm delivery rates and lower birth weight were higher in pregabalin group.Also, it should not be ignored that chronic diseases of the pregnant women in pregabalin group may affect the outcomes poorly.