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

Objectives: Cytomegalovirus (CMV) is the leading cause of congenital infection worldwide. Reference anti-CMV treatment is valganciclovir/ganciclovir, which is contraindicated in pregnancy given questions about teratogenicity.

Methods: We analysed reports from VigiBase, the world's largest safety database, and performed a disproportionality analysis of adverse pregnancy outcomes associated with (val)ganciclovir compared with any other drugs or with (val)aciclovir as comparators.

Results: Among 3 104 984 reports related to childbearing-age women or to pregnancy topics, 6186 were exposed to (val)ganciclovir or (val)aciclovir including 251 adverse pregnancy outcomes with (val)ganciclovir (n = 34) or (val)aciclovir (n = 217). We did not evidence any increased reporting of any adverse pregnancy outcome [miscarriage, stillbirth, small weight for gestational age, preterm birth (<37 weeks of gestation)] or birth defects with (val)ganciclovir compared with the use of (val)aciclovir during pregnancy. Four cases of oesophageal and anorectal atresia were identified with (val)ganciclovir, which may be related to concomitant drugs/medical conditions and require further analyses.

Conclusions: These preliminary results require confirmation but suggest the possibility for trial evaluation of val(ganciclovir) in severe maternal or fetal CMV infections.

Comments：

It appears from the analysis of VigiBase that there was no evidence of an increased risk of adverse pregnancy outcomes or birth defects associated with the use of (val)ganciclovir compared to (val)aciclovir during pregnancy. However, four cases of oesophageal and anorectal atresia were identified with (val)ganciclovir, which may require further analysis as it may be related to concomitant drugs/medical conditions. These results suggest the possibility of further evaluation of val(ganciclovir) in severe maternal or fetal CMV infections. It is important to note that these are preliminary results and should be confirmed through additional research and clinical trials before any conclusive recommendations can be made.

Related Products

Cat.No.	Product Name	Information
S4050	Valganciclovir HCl	Valganciclovir HCl is a prodrug for ganciclovir with antiviral activity used to treat cytomegalovirus infections.

Related Targets

CMV