Pregabalin alters reproductive performance in male mice and causes congenital anomalies in offspring.

Context: Pregabalin is an anticonvulsant drug with analgesic activity for the treatment of neuropathic pain.

Aims: To valuate the toxicity of pregabalin in reproductive parameters, spermatogenesis, and teratogenicity in the offspring of mice.

Methods: Twenty male mice were randomly distributed into two groups: PGB group and group C (n =10 per group). The animals in the PGB group received, via gavage, 200mg/kg of pregabalin diluted in distilled water daily, for a period of 45days. Group C received distilled water under the same experimental design.

Key Results: In the paternal parameters of the PGB group, there was a significant increase in the size of the testicles, morphological alterations in the spermatozoa, a decrease in the Johnsen score, an increase in the Leydig cells, and a decrease in the serum level of testosterone. In the intrauterine development parameters of females mated with males from the PGB group, a significant decrease in placental weight, weight and length of fetuses, and fetal viability rate was observed. There was a significant increase in the number of resorptions and post-implantation losses. The significant anomalies observed in the offspring were alteration in the size of the kidneys, absent metacarpals and phalanges, alteration in the sternum, and supernumerary thoracic vertebrae.

Conclusion: Results suggest that pregabalin had toxic effects on the reproductive function of male mice and teratogenic potential.

Implications: The findings of this study may provide new hypotheses, taking into account the risk-benefit ratio for male reproduction and offspring health.