Pregnancy Outcomes Related to Mycophenolate Exposure in Female Kidney Transplant Recipients.
In 2012, the U.S. Food and Drug Administration issued guidelines advising kidney transplant recipients (KTRs) to discontinue mycophenolate (MPA) in preparation for pregnancy. Little is known about how this guidance has affected pregnancy and graft outcomes. The purpose of this retrospective cohort study was to investigate any association between the discontinuation of MPA and KTR pregnancy and graft outcomes. Data from the National Transplantation Pregnancy Registry included 382 cases in which KTRs managed on MPA became pregnant. Overall, 22 variables, including the time in which a KTR discontinued MPA, were assessed across four end points: miscarriages, birth defects, and 2- and 5-year postpartum graft loss. Birth defects and miscarriages were similar among KTRs who discontinued MPA >6 and <6 weeks prior to pregnancy and during the first trimester. In contrast, discontinuing MPA during the second trimester or later significantly increased the risk of miscarriages (odds ratio [OR] 9.35, 95% confidence interval [CI] 4.31-20.00, p < 0.001) and birth defects (OR 6.06, 95% CI 1.96-18.87, p = 0.002). Discontinuing MPA <6 weeks prior to pregnancy was associated with an increased risk of 5-year graft loss. For the fetus, there is value to discontinuing MPA anytime prior to the second trimester. Adhering to current guidelines does not negatively affect graft survival.
University of Central Florida College of Medicine, Orlando, FL.
R W
RW
King
University of Central Florida College of Medicine, Orlando, FL.
M J
MJ
Baca
University of Central Florida College of Medicine, Orlando, FL.|National Transplantation Pregnancy Registry (NTPR), Gift of Life Institute, Philadelphia, PA.
V T
VT
Armenti
College of Health Solutions, Arizona State University, Phoenix, AZ.|Department of Nephrology, Mayo Clinic, Phoenix, AZ.
B
B
Kaplan
D000328:Adult; D005260:Female; D005500:Follow-Up Studies; D005919:Glomerular Filtration Rate; D006084:Graft Rejection / Q000188:drug therapy* / Q000209:etiology; D006085:Graft Survival / Q000187:drug effects*; D006801:Humans; D007166:Immunosuppressive Agents / Q000627:therapeutic use; D007676:Kidney Failure, Chronic / Q000601:surgery*; D007677:Kidney Function Tests; D016030:Kidney Transplantation / Q000009:adverse effects*; D009173:Mycophenolic Acid / Q000627:therapeutic use*; D011247:Pregnancy; D011256:Pregnancy Outcome; D012189:Retrospective Studies; D012307:Risk Factors; D066027:Transplant Recipients; D055815:Young Adult
D007166:Immunosuppressive Agents; D009173:Mycophenolic Acid
antiproliferative agent: mycophenolate mofetil (MMF); antiproliferative agent: mycophenolate sodium; clinical research/practice; drug toxicity; enteric coated; graft survival; immunosuppressant; kidney transplantation/nephrology; obstetrics and gynecology; pharmacology; pregnancy