Safety Concerns: Dydrogesterone in Pregnancy Linked to Higher Birth Defect Risk Than Progesterone, Study Finds
France: Researchers in a real-world observational analysis of global safety data revealed a significant and consistent increase in reported birth defects, primarily congenital heart defects (CHD) and isolated hypospadias, in pregnancies exposed to dydrogesterone, particularly when compared to progesterone. These findings, supported by other studies, highlight a potential safety signal and the need for further investigation into the fetal safety of dydrogesterone.
The study, published in Human Reproduction Open, was led by Alexandra Henry from the INSERM research unit at Université Paris Cité, France. It utilized data from the World Health Organization's global pharmacovigilance database (VigiBase) to examine the potential association between early pregnancy exposure to dydrogesterone and the occurrence of congenital anomalies.
Dydrogesterone, an oral progestin, has in recent years been considered a viable alternative to intravaginal progesterone in assisted reproductive technologies (ART), with clinical trials suggesting comparable efficacy in achieving pregnancy and similar safety profiles. However, concerns have emerged over a potential link between dydrogesterone use during early gestation and an elevated risk of birth defects, especially CHD.
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