Exposure to Mycophenolate and Fatherhood

Karsten Midtvedt1, Stein Bergan, Anna Varberg Reisæter

  • 11 Department of Transplantation Medicine, Oslo University Hospital, Rikshospitalet, Oslo, Norway. 2 Department of Pharmacology, Oslo University Hospital, Oslo, Norway. 3 Department of Pharmaceutical Biosciences, School of Pharmacy, University of Oslo, Oslo, Norway. 4 Norwegian Renal Registry, Oslo University Hospital, Rikshospitalet, Oslo, Norway. 5 Department of Clinical Medicine, University of Bergen, Bergen, Norway. 6 Department of Medicine, Haugesund Hospital, Haugesund, Norway.

Transplantation
|March 28, 2017
PubMed
Abstract

Insights

Paternal exposure to mycophenolic acid (MPA) in kidney transplant patients did not increase risks for birth defects or impact birth weight in offspring. These findings suggest MPA is safe for fathers before, during, and after conception.

Area of Science:

  • Immunology
  • Transplantation Medicine
  • Reproductive Health

Background:

  • Mycophenolic acid (MPA) is a crucial immunosuppressant used post-organ transplantation.
  • MPA is known to be teratogenic in women and may affect male fertility.
  • Limited data exists on pregnancy outcomes fathered by men exposed to MPA.

Purpose of the Study:

  • To investigate the outcomes of pregnancies fathered by renal transplant recipients exposed to MPA.
  • To determine if paternal MPA exposure influences adverse birth outcomes.

Main Methods:

  • A nationwide retrospective cohort study utilizing Norwegian registries.
  • Included renal transplant men between 1995-2015.
  • Compared pregnancy outcomes between MPA-exposed and unexposed fathers.

Main Results:

  • No significant increase in malformation risks observed in children fathered by MPA-exposed men (3.9% vs. 2.6%).
  • Birth weights were comparable between exposed and unexposed groups (3381g vs. 3429g).
  • Average MPA dose was 1.42 ± 0.3 g/day with median trough concentration of 2.8 ± 1.6 mg/L.

Conclusions:

  • Paternal exposure to MPA does not elevate the risk of adverse birth outcomes.
  • Findings are reassuring for the continuation of MPA therapy in men.
  • Supports paternal MPA use before, during, and after conception.

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