Benzydamine is a nonsteroidal anti-inflammatory drug widely used in topical formulations but occasionally misused orally at high doses for psychoactive effects. Data regarding the safety of benzydamine at supratherapeutic doses are limited and mainly focus on central nervous system effects. Even less information is available concerning its safety during pregnancy, despite the increased risk of unplanned pregnancies among users of psychoactive substances. In this preliminary study, we aimed to evaluate the maternal and fetotoxic potential of benzydamine to support future targeted reproductive toxicity investigations. Pregnant Wistar rats received benzydamine throughout gestation, followed by cesarean section and evaluation of fetal viability, fetal body weight at term, and macroscopic abnormalities. Maternal biochemical parameters related to hepatic, renal, and metabolic function, and oxidative stress markers, were also assessed. Results were compared with those of a control group. No significant differences in routine biochemical parameters were observed between groups; however, benzydamine exposure was associated with reduced fetal body weight and increased maternal plasma malondialdehyde levels. These findings suggest that benzydamine may impair fetal growth through indirect maternal toxicity and oxidative stress rather than direct teratogenic effects.
Ősz et al. (Thu,) studied this question.