Immunosuppression During Pregnancy

The U. S. Food and Drug Administration (FDA) categorizes the potential fetal risks of drugs using the following classification system: A = controlled studies, no risk; B = no evidence of risk in humans; C = risks cannot be ruled out; D = positive evidence of risk; X = contraindicated. The commonly used immunosuppressive agents are listed in Table 21.1: none of these drugs is Category A, the corticosteroids and basiliximab are Category B, and most are Category C. In infants born to renal transplant recipients exposed to azathioprine (Category D), two early reports described the incidence of congenital anomalies as 9% and 6.4% respectively.2,3 There was, however, no specific pattern noted among the kinds of anomalies that occurred. More recent reports have been more reassuring. The extensive European Dialysis and Transplant Association (EDTA) report on 490 pregnancies (500 babies) concluded that azathioprine and prednisone immuno-suppression was not associated with more congenital malformations in the newborn of renal recipients than seen in the normal population.4 Other issues that have been raised with respect to azathioprine have included: fatal neonatal anemia,

Table 21.1. Pregnancy safety information for immunosuppressive drugs used in transplantation corticosteroids (prednisone, methylprednisolone) cyclosporine (Sandimmune®, Neoral®) cyclosporine (SangCya™ Oral Solution) tacrolimus, FK506 (Prograf™) sirolimus, rapamycin (Rapamune®) azathioprine (Imuran®) mycophenolate mofetil (CellCept®) antithymocyte globulin (ATGAM®, ATG) antithymocyte globulin (Thymoglobulin®) muromonab-CD3 (orthoclone OKT®3) basiliximab (Simulect®) daclizumab (Zenapax®)

Pregnancy Category B

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