Infant exposure to Fluvoxamine through placenta and human milk: a case series - A contribution from the ConcePTION project

Anaëlle Monfort; Evelina Cardoso; Chin B Eap; Céline J Fischer Fumeaux; Myriam Bickle Graz; Mathilde Morisod Harari; Etienne Weisskopf; Peggy Gandia; Karel Allegaert; Hedvig Nordeng; Jean-Michel Hascoët; Olivier Claris; Manuella Epiney; Chantal Csajka; Monia Guidi; Ema Ferreira; Alice Panchaud

doi:10.3389/fpsyt.2023.1167870

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. eCollection 2023.

Authors

Anaëlle Monfort^{1

2}, Evelina Cardoso³, Chin B Eap^{4

5

6

7}, Céline J Fischer Fumeaux⁸, Myriam Bickle Graz⁸, Mathilde Morisod Harari⁹, Etienne Weisskopf⁴, Peggy Gandia¹⁰, Karel Allegaert^{11

12

13

14}, Hedvig Nordeng^{15

16}, Jean-Michel Hascoët¹⁷, Olivier Claris^{18

19}, Manuella Epiney²⁰, Chantal Csajka^{4

5

6}, Monia Guidi^{4

21}, Ema Ferreira^{1

2}, Alice Panchaud^{3

22}

Affiliations

¹ CHU Sainte-Justine, Montréal, QC, Canada.
² Faculty of Pharmacy, Université de Montréal, Montréal, QC, Canada.
³ Service of Pharmacy, Lausanne University Hospital and University of Lausanne, Lausanne, Switzerland.
⁴ Center for Research and Innovation in Clinical Pharmaceutical Sciences, University Hospital and University of Lausanne, Lausanne, Switzerland.
⁵ School of Pharmaceutical Sciences, University of Geneva, Geneva, Switzerland.
⁶ Institute of Pharmaceutical Sciences of Western Switzerland, University of Geneva, University of Lausanne, Geneva, Switzerland.
⁷ Unit of Pharmacogenetics and Clinical Psychopharmacology, Department of Psychiatry, Lausanne University Hospital, Lausanne, Switzerland.
⁸ Clinic of Neonatology, Department Mother-Woman-Child, Lausanne University Hospital, Lausanne, Switzerland.
⁹ Division of Child and Adolescent Psychiatry, Lausanne University Hospital, Lausanne, Switzerland.
¹⁰ Laboratory of Pharmacokinetics and Toxicology, Purpan Hospital, University Hospital of Toulouse, Toulouse, France.
¹¹ Child and Youth Institute, KU Leuven, Leuven, Belgium.
¹² Department of Development and Regeneration, KU Leuven, Leuven, Belgium.
¹³ Department of Pharmaceutical and Pharmacological Sciences, KU Leuven, Leuven, Belgium.
¹⁴ Department of Hospital Pharmacy, Erasmus MC, Rotterdam, Netherlands.
¹⁵ Pharmacoepidemiology and Drug Safety Research Group, Department of Pharmacy, PharmaTox Strategic Initiative, Faculty of Mathematics and Natural Sciences, University of Oslo, Oslo, Norway.
¹⁶ Department of Child Health and Development, Norwegian Institute of Public Health, Oslo, Norway.
¹⁷ Department of Neonatology, Maternité Régionale, Université de Lorraine, Nancy, France.
¹⁸ Department of Neonatology, Hospices Civils de Lyon, Lyon, France.
¹⁹ Claude Bernard University, P2S 4129, Lyon, France.
²⁰ Department of Women, Child and Adolescent, Geneva University Hospital, Geneva, Switzerland.
²¹ Service of Clinical Pharmacology, Lausanne University Hospital and University of Lausanne, Lausanne, Switzerland.
²² Institute of Primary Health Care (BIHAM), University of Bern, Bern, Switzerland.

Abstract

Introduction: Fluvoxamine is widely used to treat depression during pregnancy and lactation. However, limited data are available on its transfer to the fetus or in human milk. This case series provides additional information on the infant exposure to fluvoxamine during pregnancy and lactation.

Case presentation: Two women, aged 38 and 34 years, diagnosed with depression were treated with 50 mg fluvoxamine during pregnancy and lactation. At delivery a paired maternal and cord blood sample was collected for each woman. The first mother exclusively breastfed her child for 4 months and gave one foremilk and one hindmilk sample at 2 days and 4 weeks post-partum, whereas the second mother did not breastfeed.

Results: The cord to plasma concentration ratios were 0.62 and 0.48, respectively. At 2 weeks post-partum, relative infant doses (RID) were 0.47 and 0.57% based on fluvoxamine concentrations in foremilk and hindmilk, respectively. At 4 weeks post-partum, the RIDs were 0.35 and 0.90%, respectively. The child from the first mother was born healthy and showed a normal development at the 6th, 18th and 36th month follow-ups. One of the twins from the second woman was hospitalized for hypoglycemia that was attributed to gestational diabetes and low birth weight. The second one was born healthy.

Conclusion: These results suggest a minimal exposure to fluvoxamine during lactation which is in accordance with previously published data. Larger clinical and pharmacokinetic studies assessing the long-term safety of this drug during lactation and the variability of its exposure through breastmilk are warranted.

Keywords: cord blood; fluvoxamine; human milk; infant exposure; lactation; pregnancy.

Publication types

Case Reports

Grants and funding

AM received funding from the Fonds de Recherche du Québec en Nature et Technologie (FRQNT) and the Mitacs Globalink program. The work has been completed as part of the ConcePTION study. The ConcePTION project has received funding from the Innovative Medicines Initiative 2 Joint Undertaking under grant agreement No. 821520. This Joint Undertaking receives support from the European Union's Horizon 2020 research and innovation program and EFPIA. The research leading to these results was conducted as part of the ConcePTION consortium. This paper only reflects the personal views of the stated authors.