Update on the Teratogenicity of Maternal Mycophenolate Mofetil.
Mycophenolic acid (MPA) products, namely mycophenolate mofetil and mycophenolate sodium, are immunosuppressive medications used to prevent rejection in solid organ transplant recipients and to treat various autoimmune disorders. Mycophenolate therapy is considered to be teratogenic based on observational studies of pregnancies exposed to MPA, which demonstrated an increased incidence of miscarriages in pregnancies exposed to MPA during their first trimester and a pattern of birth defects in the offspring of some pregnancies exposed to MPA. Herein, we have detailed case and series reports in a comprehensive literature review summarizing what is known to date regarding fetal exposure to MPA. Based on evidence from the literature, results of postmarketing surveillance, and information from registries such as the National Transplantation Pregnancy Registry in the United States, it is advised that pregnancy be avoided by women taking MPA. Preconception planning offers the opportunity to explore the alternatives to protect the mother, her transplanted organ, and minimize fetal risk. How to proceed in cases of unplanned pregnancies exposed to MPA in transplant recipients is a complex issue. Research involving large epidemiological studies is expected to be sparse as women heed the warnings about becoming pregnant on MPA. Published recommendations for managing MPA in women of childbearing potential include discontinuing the medication prior to conception, switching the MPA to another medication, or discontinuing the MPA when the pregnancy is discovered.
National Transplantation Pregnancy Registry (NTPR), Gift of Life Institute, Philadelphia, Pennsylvania, United States.
Lisa A
LA
Coscia
National Transplantation Pregnancy Registry (NTPR), Gift of Life Institute, Philadelphia, Pennsylvania, United States.
Dawn P
DP
Armenti
University of Central Florida College of Medicine, Orlando, Florida, United States.
Ryan W
RW
King
Department of Pharmacy Practice, Temple University School of Pharmacy, Philadelphia, Pennsylvania, United States.
Nicole M
NM
Sifontis
National Transplantation Pregnancy Registry (NTPR), Gift of Life Institute, Philadelphia, Pennsylvania, United States; Department of Medicine, Temple University School of Medicine, Philadelphia, Pennsylvania, United States.
Serban
S
Constantinescu
National Transplantation Pregnancy Registry (NTPR), Gift of Life Institute, Philadelphia, Pennsylvania, United States; Department of Surgery, Lehigh Valley Health Network, Allentown, Pennsylvania, United States; Department of Surgery, Morsani College of Medicine, University of South Florida, Tampa, Florida, United States.
Michael J
MJ
Moritz
birth defect; fetus; immunosuppression; mycophenolate mofetil; mycophenolate sodium; mycophenolic acid; pregnancy; teratogen; transplantation