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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 <6 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.

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