CFTR during pregnancy and adverse drug reactions: A pharmacovigilance disproportionality analysis in VigiBase
CFTR modulators were not associated with the reporting of consistent patterns of congenital anomalies or prematurity in this large pharmacovigilance analysis. SDRs for spontaneous abortion and pre-eclampsia should be interpreted cautiously given the limitations inherent to the used study design and require confirmation in prospective pregnancy registries and controlled studies.
Authors
- Kim Dao (ORCID: https://orcid.org/0000-0002-6033-3435)
- Roberta Noseda (ORCID: https://orcid.org/0000-0002-4946-7926)
- Francesca Bedussi (ORCID: https://orcid.org/0000-0002-8584-7408)
- Nazanin Abolhassani (ORCID: https://orcid.org/0000-0002-3616-3595)
- Ursula Winterfeld (ORCID: https://orcid.org/0000-0002-9926-7164)
- Alessandro Ceschi (ORCID: https://orcid.org/0000-0002-4308-0405)
- Alice Panchaud (ORCID: https://orcid.org/0000-0001-6086-2401)
Institutions
- University of Bern (CH)
- Centre Hospitalier Universitaire Vaudois (CH)
- Ente Ospedaliero Cantonale (CH)
- University of Lausanne (CH)
Publication Details
- Journal
- Journal of Cystic Fibrosis
- Published
- 2025-11-20
- DOI
- https://doi.org/10.1016/j.jcf.2025.11.007
- Primary Topic
- Pregnancy and Medication Impact
- Type
- article
- Field-Weighted Citation Impact
- 0.00
Funders
- World Health Organization