No association between inadvertent exposure to ribostamycin during early pregnancy and fetal ototoxicity

Objective: Our goal was to evaluate a potential association between exposure to ribostamycin in early pregnancy and ototoxicity in the offspring. Methods: In a prospective cohort study, 85 women inadvertently exposed to ribostamycin during the first trimester of pregnancy and 170 ageand gravidity-matched control women, were voluntarily enrolled. Newborns were clinically examined at birth by a neonatologist and by imaging studies if any suspicious abnormalities were noted. Hearing was assessed directly by auditory brainstem response. Results: No newborn had neonatal ototoxicity in the exposed group (0/70) whereas 1/160 (0.6%) had evidence of ototoxicity in the control group (P =0.5). Conclusions: Exposure to ribostamycin during the first-trimester of pregnancy does not appear to be associated with ototoxicity in the offspring. Although exposure occurred at very early stages of fetal development, when the inner ear was not yet developed, our findings may be valuable when counseling women inadvertently exposed to this aminoglycoside in early pregnancy.