FDA Warns of Myfortic and CellCept Birth Defect Risks

On Friday, the FDA posted an alert on their website to provide additional information to doctors about the possible risk of miscarriages and birth defects associated with the use of CellCept and Myfortic during pregnancy. A black box warning was added to the organ transplant medications in November 2007, but the FDA issued a second alert last week since the drugs are often prescribed “off-label” for unapproved uses, such as treating lupus, and many doctors remain unaware of the danger of fetal injury.

CellCept (mycophenolate mofetil) is manufactured by Roche, and Myfortic (mycophenolic acid) is manufactured by Novartis AG. Both drugs are are immunosuppressants, which are designed to prevent organ rejection following a transplant. Reports indicate that use during pregnancy could increase the risk of spontaneous abortions (miscarriages) and congential malformations, such as cleft lips, cleft palates and ear deformities.

According to data in the National Transplantation Pregnancy Registry (NTPR), out of 33 pregnant women exposed to CellCept, just under half of the pregnancies (15) resulted in a spontaneous abortion. For those that resulted in a live birth, four out of the 18 babies (22%) had malformations. For post-organ transplant women who were taking other immunosuppressive drugs, the NTPR data indicates only 4-5% of babies were born with structural malformations.

Although there have been no official reports of Myfortic birth defects, since the drug is chemically similar to CellCept, the FDA has indicated the same risk of fetal injury could apply. The active pharmaceutical ingredient in CellCept is MMF (mycophenolate mofetil), which is an ester of MPA (metobolite mycophenolic acid), the active ingredient in Myfortic.