Paternal safety of the use of mycophenolic acid in kidney transplant recipients. Results of the EMVARON study

Abstract

Background The use of mycophenolic acid (MPA) in women during pregnancy causes an increase in miscarriages and birth defects with a typical embryopathy profile. Although epidemiological data does not suggest a greater risk among the offspring of male kidney transplant recipients, the European Medicines Agency and The Spanish Agency of Medicines and Medical Devices introduced the recommendation of using contraceptive methods. Methods We conducted a national retrospective study in 15 Spanish Kidney Transplant Centers to evaluate the frequency of miscarriages and birth defects between the offspring from male kidney transplants recipients. We included 151 males who had fathered 239 offspring, 225 under MPA and 14 without MPA. Results The results of our study showed an incidence of miscarriages in the MPA group of 9.8%, and of birth defects of 4%. Conclusions We observed an incidence of miscarriages between the offspring fathered by kidney transplant males under MPA lower than the general population. The incidence of birth defects was similar to the incidence described in other studies and the fact that we did not find the typical embryopathy profile makes it difficult to associate them to the use of MPA. Because of that, we urge the European and Spanish Agencies to reconsider their recommendations for males.

Parenthood With Kidney Failure: Answering Questions Patients Ask About Pregnancy

“…However, given several studies from different cohorts reporting excellent outcomes for children fathered by males exposed to mycophenolic acid, men may be counseled that there is no currently clear signal for increased fetal malformations. 137,[139][140][141][142][143][144] Mammalian target of rapamycin inhibitors influence spermatogenesis and fertility rates in animal models and humans, 145,146 but there is uncertainty about the effect of other immunosuppressants owing to rarity of cases. The impact of immunosuppression switch in male transplant recipients for the purpose of conception is also unknown.…”