Pregnancy Outcomes with Exposure to the Mycophenolic Acid Products (MPA)

Conclusions: Reports to NTPR to date continue to reveal an increased incidence of birth defects in transplant recipients maintained on MPA products during gestation compared to those not maintained on these agents. Structural birth defects consisting of microtia (ear deformity) and facial defects suggest a pattern of malformations. Evaluation of the higher incidence of non-viable outcomes requires further study in this cohort. Centers are encouraged to report all pregnancy exposures in transplant recipients to the NTPR

Pregnancy Outcomes in Female Lung Transplant Recipients

Conclusions: Female lung recipients appear to face higher risks related to pregnancy when compared to other solid organ transplant recipients. Although successful pregnancies have been reported in female lung recipients, analyses of larger numbers of cases may help to identify pre-pregnancy factors predictive of adverse outcomes. Centers are encouraged to report all pregnancies in transplant recipients to the NTPR

Pregnancy Outcomes in Pancreas-Kidney vs. Kidney-Alone Diabetic Female Transplant Recipients

Conclusions: The high incidences of hypertension, preeclampsia, and infection during pregnancy underscore the high-risk nature of pregnancy in both pancreas-kidney and kidney alone recipients. Although overall offspring outcomes are similar in both PK and K groups, pregnancy in PK recipients may be associated with higher incidences of maternal infections and overall graft loss. Centers are encouraged to report all pregnancies in transplant recipients to the NTPR

Immunosuppressive Therapy for Autoimmune Disease and Pregnancy Outcomes

Conclusions: Cyclosporine exposure during pregnancy in the transplant population does appear to be associated with premature delivery and low infant birthweight. Data from the NPR show that cyclosporine exposure during pregnancy in women with psoriasis does not appear to be associated with low gestational age or low infant birthweight. Maternal comorbidities or other factors, such as multiple drug regimens, likely play a role in the higher rates of premature delivery and low birthweight infants in the kidney transplant population. Further investigation is warranted to evaluate the impact of comorbidities and other factors on pregnancy outcomes of women taking Neoral®

Solid-Organ Transplant Recipients and Breastfeeding While on Immunosuppression

Conclusions: The relatively small amount of drug transferred in breast milk and the lack of reported adverse effects along with the known benefits of breastfeeding may outweigh the risk of drug exposures in the transplant population. The threshold for determining the level of exposure of an immunosuppressive agent that is acceptable is not known at present. Continued study and follow-up of all breast-fed transplant recipient offspring is warranted. Centers are encouraged to report all pregnancies in transplant recipients to the NTRR

Pregnancy in female pediatric solid organ transplant recipients.

This article from the National Transplantation Pregnancy Registry (NTPR) describes the pregnancy outcomes of female transplant recipients who received a solid organ transplant when younger than 21 years old. The analysis includes kidney, liver, liver-kidney, heart, and lung recipients. No recipients in the registry received a pancreas-kidney or heart-lung transplant before age 21. To date, the NTPR has not received report of a pregnancy in a small bowel recipient. This article also reviews immunosuppressive medications with regard to pregnancy safety

Parenthood with Exposure to Mycophenolic Acid Products

Successful pregnancy outcomes have been reported in all solid-organ transplant recipients on a variety of immunosuppressive medication regimes. In October 2007, the FDA pregnancy category of mycophenolic acid products (MPA) was changed from category C to D, based on registry and post-marketing data which revealed a higher incidence of spontaneous abortions and structural birth defects. The purpose of this abstract is to describe pregnancy outcomes with exposure to MPA and pregnancies fathered by male transplant recipients conceived while taking MPA. Data were collected by the National Transportation Pregnancy Registry (NTPR) via questionnaires, telephone interview and medical records. There were 152 conceptions in female recipients with exposure to MPA (discontinued \u3c6 weeks prior to conception or with use during pregnancy). Outcomes included: 78 live births, 70 spontaneous abortions, 3 stillbirths and 1 therapeutic abortion. Among the live births, there were 14 malformations reported for an incidence of (18%) compared to the incidence of malformations in transplant recipients not exposed to MPA, which is approximately 4.9%. There were 146 male recipients who have fathered 199 pregnancies with 202 outcomes (including twins). Outcomes included: 188 live births, 14 spontaneous abortions, and no therapeutic abortions or stillbirths. Among the live births there were 6 malformations reported, for an incidence of 3.2%. Conclusions: Reports to the NTPR reveal an increased incidence of non-viable outcomes and a pattern of structural malformations in pregnancies exposed to MPA in female transplant recipients compared to those without exposure to MPA. Those pregnancies fathered by male recipients appear similar to that of the general population. Healthcare providers are encouraged to report all pregnancy outcomes in transplant recipients to the NTPR

Pregnancy after transplantation.

The National Transplantation Pregnancy Registry (NTPR) was established in 1991 to study the outcomes of pregnancies in female transplant recipients and pregnancies fathered by male transplant recipients. Data from the NTPR have helped to endorse the reassurances from publications of smaller experiences that successful pregnancies are possible in the transplant population. In our last review for this journal (2000), we noted that important future issues would include the reassessment of prepregnancy guidelines, gestational and organ-specific problems, the role of new immunosuppressive drugs, and the long-term effects of pregnancy on both graft and child. Data collected by the NTPR over the last 7 years have addressed these issues, thus providing additional information for health care providers of transplant recipients of childbearing age. There has been some refinement of prepregnancy guidelines, but there is a need for additional data collection so that organ-specific outcomes and risks can further be identified. To date, the outcomes of the children followed have been encouraging, and specific remote effects have not been identified, but continued surveillance is still vital. Of special concern are the new immunosuppressive drugs, specifically for mycophenolate mofetil (CellCept, Roche Laboratories Inc., Nutley, New Jersey), where data reported to the NTPR and through postmarketing surveillance have shown an increased incidence of nonviable outcomes and a specific pattern and increased incidence of malformation in the newborn, which has resulted in a pregnancy category change. Newer information points to an increased need for vigilance among centers and continued monitoring of pregnancy outcomes in this population. As the first reported pregnancy after transplantation occurred in a kidney recipient 50 years ago, in March 1958, this review also highlights the first reported pregnancies in other solid organ recipients