Reply: Fetal safety of dydrogesterone: clarifying the role of pharmacovigilance

other OA: gold public-domain-us
AI-generated summary by qwen3.7-flash, 2026-08-17

This reply addresses fetal safety concerns regarding dydrogesterone by clarifying the role of pharmacovigilance in evaluating its use during pregnancy.

One-sentence paraphrase of the abstract; not a substitute for reading it. No clinical advice. How this works

AI-generated deep summary by qwen3.7-flash, 2026-08-17 · read from full text

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.

Read from the paper's body, not the abstract. Not a substitute for reading the paper. No clinical advice. How this works

Full text 3,803 characters · extracted from epmc-fulltextxml · 2 sections · click to expand

Conflict

M.B., C.C., C.M., and P.S. have received institutional funding from Merck, Ferring, Theramex, Gedeon Richter, and Besins. M.B. has received personal honoraria from Merck, Ferring, Gedeon Richter, Theramex, IBSA, and Organon for lectures, presentations, or educational events, and has received non-monetary support for attending meetings from Ferring and Gedeon Richter. C.C. has received personal honoraria from Merck, Besins, Gedeon Richter, and Theramex, and non-monetary support for attending meetings from Besins, Gedeon Richter, and Merck. He is the Founder and Past-President of the Society for Endometriosis and Uterine Disorders (SEUD), an unpaid role. C.M. has received personal consulting fees from Gedeon Richter and Ferring and honoraria from Merck Serono, Ferring, Besins, IBSA, and Organon for lectures or educational events. She has received non-monetary support for attending meetings from Ferring, Besins, and Gedeon Richter. P.S. has received personal honoraria from Merck, Ferring, Besins, Gedeon Richter, Theramex, IBSA, and General Electrics Medical Systems for lectures and educational events. He has also received non-monetary support for attending meetings from Merck, Ferring, Besins, Gedeon Richter, Theramex, and IBSA. He is a Board Member of SEUD and serves on the Editorial Boards of RBMO and GOF, all unpaid roles. J.G. has received institutional funding from Pregnomic and DiaSorin. He has received personal honoraria from Elsevier and Merck for lectures and educational events. He is a Board Member of ABA and SFE, an unpaid position. L.C., J.-M.T., and A.H. declare no conflicts of interest.

Contrib Info

Laurent Chouchana, Pharmacology Department, Regional Center of Pharmacovigilance, Cochin Hospital, AP-HP.Centre—Université Paris Cité, Paris, France; «Pharmacologie et évaluation des thérapeutiques chez l’enfant et la femme enceinte», Université Paris Cité, INSERM UMR-S1343, Paris, France. Alexandra Henry, Pharmacology Department, Regional Center of Pharmacovigilance, Cochin Hospital, AP-HP.Centre—Université Paris Cité, Paris, France; «Pharmacologie et évaluation des thérapeutiques chez l’enfant et la femme enceinte», Université Paris Cité, INSERM UMR-S1343, Paris, France. Mathilde Bourdon, Faculté de Santé, Université Paris Cité, Paris, France; Department of Gynaecology Obstetrics II and Reproductive Medicine, Cochin Hospital, AP-HP.Centre—Université Paris Cité, Paris, France; Department 3I « Infection, Immunité et inflammation », Institut Cochin, INSERM U1016, Paris, France. Chloé Maignien, Faculté de Santé, Université Paris Cité, Paris, France; Department of Gynaecology Obstetrics II and Reproductive Medicine, Cochin Hospital, AP-HP.Centre—Université Paris Cité, Paris, France. Charles Chapron, Faculté de Santé, Université Paris Cité, Paris, France; Department of Gynaecology Obstetrics II and Reproductive Medicine, Cochin Hospital, AP-HP.Centre—Université Paris Cité, Paris, France; Department 3I « Infection, Immunité et inflammation », Institut Cochin, INSERM U1016, Paris, France. Jean-Marc Treluyer, Pharmacology Department, Regional Center of Pharmacovigilance, Cochin Hospital, AP-HP.Centre—Université Paris Cité, Paris, France; «Pharmacologie et évaluation des thérapeutiques chez l’enfant et la femme enceinte», Université Paris Cité, INSERM UMR-S1343, Paris, France. Jean Guibourdenche, Faculté de Santé, Université Paris Cité, Paris, France; Department of Hormonology, Cochin Hospital, AP-HP.Centre—Université Paris Cité, Paris, France. Pietro Santulli, Faculté de Santé, Université Paris Cité, Paris, France; Department of Gynaecology Obstetrics II and Reproductive Medicine, Cochin Hospital, AP-HP.Centre—Université Paris Cité, Paris, France; Department 3I « Infection, Immunité et inflammation », Institut Cochin, INSERM U1016, Paris, France.

Text is read by the "Ask this paper" AI Q&A widget below. Extraction quality varies by source — PMC NXML preserves structure cleanly, OA-HTML may include some navigation residue, and OA-PDF can have broken hyphenation. The publisher copy (via DOI) is the canonical version.

My notes (saved in your browser only)

Ask this paper AI returns verbatim quotes from the full text · source: epmc-fulltextxml

Answers must be backed by verbatim quotes from this paper's full text. Hallucinated quotes are dropped automatically; if no verbatim passage answers the question, we say so. How this works

Citation neighborhood (no data yet)

We don't have any in-corpus citations linked to this paper yet. This is a recent paper (2025) — citers typically take a year or two to land, and the OpenAlex reference graph may still be filling in.

Source provenance

europepmc
last seen: 2026-08-16T09:21:09.727480+00:00
pubmed
last seen: 2026-08-19T06:05:28.670630+00:00
License: public-domain-us · commercial use OK · attribution required
Courtesy of the U.S. National Library of Medicine