Assessing the risk of adverse pregnancy outcomes and birth defects reporting in women exposed to ganciclovir or valganciclovir during pregnancy: a pharmacovigilance study.

This article focuses on the safety of ganciclovir and its oral prodrug valganciclovir [(val)ganciclovir] during pregnancy, using data from VigiBase, the World Health Organization’s global pharmacovigilance database. The study analyzed adverse pregnancy outcomes reported with (val)ganciclovir exposure compared to aciclovir/valaciclovir [(val)aciclovir] and other drugs, finding no increased reporting of miscarriage, stillbirth, preterm birth, or overall birth defects associated with (val)ganciclovir. However, a small cluster of gastrointestinal birth defects was noted with (val)ganciclovir, though these cases involved concomitant exposure to other drugs such as sulfamethoxazole-trimethoprim, complicating causal interpretation. The findings suggest that while (val)ganciclovir does not show a clear safety signal for adverse pregnancy outcomes, further prospective studies and clinical trials are needed to confirm its safety and evaluate its use in severe maternal or fetal cytomegalovirus (CMV) infections.