Reply: Fetal safety of dydrogesterone: clarifying the role of pharmacovigilance
This reply addresses fetal safety concerns regarding dydrogesterone by clarifying the role of pharmacovigilance in evaluating its use during pregnancy.
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This correspondence addresses fetal safety concerns regarding dydrogesterone by emphasizing the critical role of pharmacovigilance in evaluating drug risks during pregnancy. The authors clarify that while spontaneous reports may suggest associations, rigorous analysis is required to distinguish between causal effects and background incidence rates of congenital anomalies. They argue against premature conclusions drawn from limited data, advocating for continued monitoring rather than immediate regulatory restrictions based on unconfirmed signals. Relevance to endometriosis: dydrogesterone is a progestin frequently used in the medical management of endometriosis-associated pain and adenomyosis symptoms, making its safety profile during potential conception or early pregnancy relevant to patients with these conditions.
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- europepmc
- last seen: 2026-08-16T09:21:09.727480+00:00
- pubmed
- last seen: 2026-08-19T06:05:28.670630+00:00
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