The FDA has ordered a black box warning on the use of mycophenolate mofetil (CellCept) during pregnancy
The FDA has ordered a black box warning on the use of mycophenolate mofetil (CellCept) during pregnancy.
In announcing the label change, the agency cited an increased risk of spontaneous abortion or congenital malformation for transplant patients who become pregnant while using the immunosuppressant.
Post-marketing data from the National Transplantation Pregnancy Registry (NTPR) and worldwide adverse event reporting found an increased risk of cleft lip and palate, malformation of the external ear, and anomalies of distal limbs, heart, esophagus, and kidney.
Roche, the drug’s maker, said that in December 2006 NTPR published data from prospective cases where 24 female transplant patients reported 33 pregnancies exposed to mycophenolate mofetil-containing regimens.
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