Paternal safety of the use of mycophenolic acid in kidney transplant recipients. Results of the EMVARON study
Por:
Martin-Moreno, P, Sanchez-Fructuoso, A, Mazuecos, A, Mir, M, Lopez-Lopez, I, Gonzalez-Rinne, A, Coca, A, Valero, R, Galiano, A, Ridao, N, Toapanta-Gaibor, N, Fernandez-Tagarro, E, Cruzado-Vega, L, Perez-Mir, M and Jimenez, C
Publicada:
1 may 2021
Ahead of Print:
1 feb 2021
Categoría:
Transplantation
Resumen:
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.
Filiaciones:
Martin-Moreno, P:
Clin Univ Navarra, Navarra Inst Hlth Res IdiSNA, Nephrol Dept, Pamplona, Spain
Sanchez-Fructuoso, A:
Hosp Clin Univ San Carlos, Nephrol Dept, Madrid, Spain
Mazuecos, A:
Hosp Puerta del Mar, Nephrol Dept, Cadiz, Spain
Mir, M:
Hosp Mar, Nephrol Dept, Barcelona, Spain
Univ Autonoma Barcelona, Hosp Univ Germans Trias & Pujol, Nephrol Dept, Kidney Transplant Unit, Barcelona, Spain
Lopez-Lopez, I:
Hosp Univ Reina Sofia, Inst Maimonides Invest Biomed COrdoba IMIBIC, Nephrol Dept, Cordoba, Spain
Gonzalez-Rinne, A:
Univ La Laguna, Inst Tecnol Biomed ITB, Nephrol Dept, Hosp Univ Canarias, Tenerife, Spain
Coca, A:
Hosp Clin Univ Valladolid, Nephrol Dept, Valladolid, Spain
Valero, R:
Univ Cantabria, Nephrol Dept, IDIVAL, HU Marques Valdecilla, Santander, Spain
Galiano, A:
Hosp Univ & Politecn La Fe, Kidney Transplant Unit, Valencia, Spain
Ridao, N:
Hosp Univ Cent Asturias, Nephrol Dept, Oviedo, Spain
Toapanta-Gaibor, N:
Hosp Vail dHebron, Nephrol Dept, Barcelona, Spain
Fernandez-Tagarro, E:
Complejo Hosp Univ Insular Materno Infantil, Nephrol Dept, Las Palmas Gran Canaria, Spain
:
Hosp Gen Univ Elche, Nephrol Dept, Elche, Spain
Perez-Mir, M:
Univ Autonoma Barcelona, Hosp Univ Germans Trias & Pujol, Nephrol Dept, Kidney Transplant Unit, Barcelona, Spain
Jimenez, C:
Hosp Univ La Paz, Nephrol Dept, Madrid, Spain
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