Researchers at PharmaSafe, University of Oslo are involved in several of the work packages. They are:
WP1: Using large health care data bases to study medication use and safety in pregnancy.
UIO researchers are involved in 5 unique multinational demonstration studies:
| Medication | NOVELTY |
| Gabapentionoids | Will provide solution for how we account for the underlying indication for medication use thus limiting the “disease bias” in future medications in pregnancy studies |
| Antidepressants | Providing solution for measuring long term childhood outcomes: time varying confounding factors e.g. breastfeeding |
| MS | Novel statistics to handle rare diseases and small sample sizes. |
| Migraine | Demonstrating solutions for studying intermittent medication exposures in diseases with episodic manifestations during pregnancy. |
| Pregnancy associated Breast Cancer | Studying drug exposure when disease is measured through accurate identification of an incident case. |
WP2: Improving studies using primary data collection and spontaneous reports
In this work package, we contributed with expertise on neurodevelopmental outcomes.
The following consensus was published.
Bromley RL, Bickle Graz M, Bluett-Duncan M, Chambers C, Damkier P, Dietrich K, Dolk H, Grant K, Mattson S, Meador KJ, Nordeng H, Oberlander TF, Ornoy A, Revet A, Richardson J, Rovet J, Schuler-Faccini L, Smearman E, Simms V, Vorhees C, Wide K, Wood A, Yates L, Ystrom E, Supraja TA, Adams J. Expert consensus on neurodevelopmental outcomes in pregnancy pharmacovigilance studies. Front Pharmacol. 2023 Jun 1;14:1094698.
WP3 and WP4: Medications & Breastfeeding
UIO was responsible and completed one human lactation study. In total, 32 women from Norway contributed with milk samples. The results showed minimal breast milk transfer of cetirizine, with an estimated absolute infant daily dose of 2.5 μg/kg and a relative infant daily dose of less than 2% confirming that breastfeeding is compatible with use of (levo)cetirizine.
Website of the Levocetirizine study
WP5: Development of a knowledge bank and training program
Hedvig Nordeng has drafted the training module on Medications & Breastfeeding
WP7: Data analytical pipeline and ConcePTION Common Data Model
Work in this work package was instrumental in creating and testing out tools for analyzing heterogenous heath data across Europe using the ConcePTION Common Data Model. The ConcePTION Pregnancy algorithm identified pregnancies from birth registries and patient registries.
Read about the concept here:
Thurin NH, Pajouheshnia R, Roberto G, Dodd C, Hyeraci G, Bartolini C, Paoletti O, Nordeng H, Wallach-Kildemoes H, Ehrenstein V, Dudukina E, MacDonald T, De Paoli G, Loane M, Damase-Michel C, Beau AB, Droz-Perroteau C, Lassalle R, Bergman J, Swart K, Schink T, Cavero-Carbonell C, Barrachina-Bonet L, Gomez-Lumbreras A, Giner-Soriano M, Aragón M, Neville AJ, Puccini A, Pierini A, Ientile V, Trifirò G, Rissmann A, Leinonen MK, Martikainen V, Jordan S, Thayer D, Scanlon I, Georgiou ME, Cunnington M, Swertz M, Sturkenboom M, Gini R. From Inception to ConcePTION: Genesis of a Network to Support Better Monitoring and Communication of Medication Safety During Pregnancy and Breastfeeding. Clin Pharmacol Ther. 2022 Jan;111(1):321-331.
Publications
Work in WP3 and WP4 have resulted in several publications including:
- Limoncella G, Girardi A, Bartolini C, Hyeraci G, Roberto G, Paoletti O, Messina D, Villalobos F, Bisacco CA, van den Berg J, Houben E, Santaca k, Ingrasciotta Y, Trifiro G, Pellegrini G, Ientile V, Hoxhaj V, Duran C, Riera-Arnau J, Garcia-Poza P, Martin-Perez M, Llorente-Garcia A, Cea-Soriano L, Huerta-Alvarez C, Sanchez-Saez F, Sanfelix-Gimeno G, Rodriguez-Bernal CL, Jove J, Bernard MA, Thurin NH, Jordan S, Thayer D, Evans HT, Coldea AI, Manfrini M, Van Gelder M, Tari M, Pajouheshnia R, Afonso Maciel AS, Le Noan-Laine M, Molgaard-Nielsen D, Cunnington M, Dodd C, Grilli L, Andaur Navarro CL, Sturkenboom M, Nordeng H, Gini R. Identifying pregnancies in population-based data sources: development and application of the concePTION pregnancy algorithm. Drug Saf. 2026 Aug;35(8):e70438. doi: 10.1002/pds.70438
- Nordeng H, Wegler C, Lindqvist A, Melander E, Magnusson M, Gandia P, Panchaud A, Baranczewski P, Spigset O. Transfer of cetirizine/levocetirizine into human breast milk and estimation of drug exposure to infants through breastfeeding: A human lactation study from the ConcePTION project. Basic Clin Pharmacol Toxicol. 2024 Jan;134(1):153-164.
- Cardoso E, Guidi M, Nauwelaerts N, Nordeng H, Teil M, Allegaert K, Smits A, Gandia P, Edginton A, Ito S, Annaert P, Panchaud A. Safety of medicines during breastfeeding - from case report to modeling: a contribution from the ConcePTION project. Expert Opin Drug Metab Toxicol. 2023 Jan-Jun;19(5):269-283.
- Nauwelaerts N, Deferm N, Smits A, Bernardini C, Lammens B, Gandia P, Panchaud A, Nordeng H, Bacci ML, Forni M, Ventrella D, Van Calsteren K, DeLise A, Huys I, Bouisset-Leonard M, Allegaert K, Annaert P. A comprehensive review on non-clinical methods to study transfer of medication into breast milk – A contribution from the ConcePTION project. Biomed Pharmacother. 2021 Apr;136:111038. doi: 10.1016/j.biopha.2020.111038. Epub 2021 Jan 30. PMID:33526310.
- Cardoso E, Monfort A, Ferreira E, Nordeng H, Winterfeld U, Allegaert K, Gandia P, Guidi M, Panchaud A. Maternal drugs and breastfeeding: Risk assessment from pharmacokinetics to safety evidence - A contribution from the ConcePTION project. Therapie. 2023 Mar-Apr;78(2):149-156. doi: 10.1016/j.therap.2023.01.008. Epub 2023 Jan 31. PMID: 36804048.
- Monfort A, Cardoso E, Eap CB, Ansermot N, Crettol S, Fischer Fumeaux CJ, Graz MB, Harari MM, Weisskopf E, Gandia P, Allegaert K, Annaert P, Nordeng H, Hascoët JM, Claris O, Epiney M, Ferreira E, Leclair G, Csajka C, Panchaud A, Guidi M; Collaborators of the SSRI Breast Milk study. A population pharmacokinetic model for sertraline in women during the perinatal period-A contribution from the ConcePTION project. Br J Clin Pharmacol. 2024 Jul 19. doi: 10.1111/bcp.16177. Epub ahead of print. PMID: 39030897.
- Monfort A, Cardoso E, Eap CB, Fischer Fumeaux CJ, Graz MB, Morisod Harari M, Weisskopf E, Gandia P, Allegaert K, Nordeng H, Hascoët JM, Claris O, Epiney M, Csajka C, Guidi M, Ferreira E, Panchaud A. Infant exposure to Fluvoxamine through placenta and human milk: a case series - A contribution from the ConcePTION project. Front Psychiatry. 2023 May 18;14:1167870. doi: 10.3389/fpsyt.2023.1167870. PMID: 37275991; PMCID: PMC10232980.
Collaborators
The ConcePTION project unites an 88 organizations from 22 countries, including the European Medicines Agency, drug manufacturers, academia, public health organizations, and teratology networks to innovate new solutions to a decades-long public health issue.