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Peer-reviewedCC BY-NC 4.0The European Journal of Public Health

Top drugs used in pregnancy: population-based congenital anomaly registry & dispensing data in Spain

Abstract

Background: Drug use (DU) in pregnancy (preg) has been related to the development of some congenital anomalies (CA).

Aim: to identify DU in women with CA preg outcomes in Valencian Region, describe their demographic and clinical profile and identify the CA group present in top DU

Methods: Women were selected from the CA population-based Registry, including live (LB) or stillbirths with a CA born 2013-2021. Unidentified women and multiple pregs were excluded. DU was detected from the regional dispensing drugs dataset. Proportion (%) of women with DU was estimated and top common DU in preg and by trimester (T) were computed. Women’s profile were described and prevalence by CA groups were estimated for top DU

Results: Out of 6277 women were identified, 75% with at least one dispensation during preg, 42% in the 1T, 48.1% in 2T and 45.7% in 3T. Top DU groups detected were [% women with DU in preg;1T;2T;3T]: Antianemic (B03) [42.8;9.1;21.0;21.4], Antibacterials [30.3;13.0;13.5;12.4], Analgesics [26.4;12.0;12.3;8.0]; Thyroid therapy [11.9;6.8;5.7;3.0]. Top common drug were: Paracetamol, Iron, Fosfomycin, Levothyroxine and Amoxicillin; except in 1T when Progesterone and Folic acid were used more widely. In all DUs analysed, the % of maternal or gestational disease was significantly(p < 0.001) higher. B03 was related to a higher %(p < 0.001) of: LB, weight >2500g and length >37 gestational weeks. Progesterone was related to a higher %(p < 0.001) of: genital CA, low weight, prematurity and older than 35 years

Conclusions: Top common DUs were aligned with those described in similar studies. Most of DU showed a positive risk-benefit ratio except Progesterone, which use was related to adverse outcomes at delivery and higher prevalence of certain CA. The study shows insights to support decision-making by healthcare professionals and researchers, as well as in the development of health policies, by creating a less hostile environment for women and helping to address existing uncertainties

Key messages: • This study has estimated that most of drugs used in pregnancy are safe, but some of uncertain risk, particularly used in the first trimester, suggest higher occurrence of certain congenital anomalies.

• Studying data from population registries provides essential insights into groups rarely represented in drug safety clinical research, such as pregnant women and children with congenital anomalies.

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BibTeX
@article{barrachinabonet2026drugs,
  title = {{Top drugs used in pregnancy: population-based congenital anomaly registry & dispensing data in Spain}},
  author = {L Barrachina-Bonet and L García-Villodre and L Páramo-Rodríguez and B Arribas-Díaz and A Torró-Gómez and N García-Flores and P Oña-Nieto and C Martos and J V Sorlí and C Cavero-Carbonell},
  journal = {The European Journal of Public Health},
  year = {2026},
  month = oct,
  doi = {10.1093/eurpub/ckag169.1692},
  url = {https://doi.org/10.1093/eurpub/ckag169.1692},
  note = {CC BY-NC 4.0},
}
RIS
TY  - JOUR
TI  - Top drugs used in pregnancy: population-based congenital anomaly registry & dispensing data in Spain
AU  - L Barrachina-Bonet
AU  - L García-Villodre
AU  - L Páramo-Rodríguez
AU  - B Arribas-Díaz
AU  - A Torró-Gómez
AU  - N García-Flores
AU  - P Oña-Nieto
AU  - C Martos
AU  - J V Sorlí
AU  - C Cavero-Carbonell
PY  - 2026
DA  - 2026/10/01
JO  - The European Journal of Public Health
DO  - 10.1093/eurpub/ckag169.1692
UR  - https://doi.org/10.1093/eurpub/ckag169.1692
AB  - Background: Drug use (DU) in pregnancy (preg) has been related to the development of some congenital anomalies (CA).  Aim: to identify DU in women with CA preg outcomes in Valencian Region, describe their demographic and clinical profile and identify the CA group present in top DU  Methods: Women were selected from the CA population-based Registry, including live (LB) or stillbirths with a CA born 2013-2021. Unidentified women and multiple pregs were excluded. DU was detected from the regional dispensing drugs dataset. Proportion (%) of women with DU was estimated and top common DU in preg and by trimester (T) were computed. Women’s profile were described and prevalence by CA groups were estimated for top DU  Results: Out of 6277 women were identified, 75% with at least one dispensation during preg, 42% in the 1T, 48.1% in 2T and 45.7% in 3T. Top DU groups detected were [% women with DU in preg;1T;2T;3T]: Antianemic (B03) [42.8;9.1;21.0;21.4], Antibacterials [30.3;13.0;13.5;12.4], Analgesics [26.4;12.0;12.3;8.0]; Thyroid therapy [11.9;6.8;5.7;3.0]. Top common drug were: Paracetamol, Iron, Fosfomycin, Levothyroxine and Amoxicillin; except in 1T when Progesterone and Folic acid were used more widely. In all DUs analysed, the % of maternal or gestational disease was significantly(p < 0.001) higher. B03 was related to a higher %(p < 0.001) of: LB, weight >2500g and length >37 gestational weeks. Progesterone was related to a higher %(p < 0.001) of: genital CA, low weight, prematurity and older than 35 years  Conclusions: Top common DUs were aligned with those described in similar studies. Most of DU showed a positive risk-benefit ratio except Progesterone, which use was related to adverse outcomes at delivery and higher prevalence of certain CA. The study shows insights to support decision-making by healthcare professionals and researchers, as well as in the development of health policies, by creating a less hostile environment for women and helping to address existing uncertainties  Key messages: • This study has estimated that most of drugs used in pregnancy are safe, but some of uncertain risk, particularly used in the first trimester, suggest higher occurrence of certain congenital anomalies.  • Studying data from population registries provides essential insights into groups rarely represented in drug safety clinical research, such as pregnant women and children with congenital anomalies.
SN  - 1101-1262
SN  - 1464-360X
ER  -