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Paternal safety of the use of mycophenolic acid in kidney transplant recipients. Results of the EMVARON study
Author(s) -
MartinMoreno Paloma L.,
SánchezFructuoso Ana I.,
Mazuecos Auxiliadora,
Mir Marisa,
LopezLopez Isabel,
GonzálezRinne Ana,
Coca Armando,
Valero Rosalía,
Ventura Galiano Ana,
Ridao Natalia,
ToapantaGaibor Nestor G.,
FernándezTagarro Ernesto,
CruzadoVega Leonidas,
PérezMir Mónica,
Jiménez Carlos
Publication year - 2021
Publication title -
clinical transplantation
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.918
H-Index - 76
eISSN - 1399-0012
pISSN - 0902-0063
DOI - 10.1111/ctr.14256
Subject(s) - medicine , offspring , incidence (geometry) , pregnancy , kidney transplant , epidemiology , mycophenolic acid , population , obstetrics , kidney transplantation , pediatrics , kidney , gynecology , transplantation , environmental health , genetics , physics , optics , biology
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.