FDA Orders Black Box Pregnancy Warning for Transplant Agent

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FDA

Orders Black Box Pregnancy Warning for Transplant Agent

Reviewed by Zalman S. Agus, MD; Emeritus Professor at the University of

Pennsylvania School of Medicine.

October 29, 2007

ROCKVILLE, Md., Oct. 29 -- The FDA said today it 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.

Forty-five percent of those pregnancies resulted in

spontaneous abortions and 18 live-born infants. Four

of the infants had structural malformations.

According to post-marketing data collected from 1995 through

2005, 77 pregnant women exposed to the drug had 25 spontaneous abortions and

14 congenital malformations. Six of the 14

malformations involved ear abnormalities.

In a letter to health care professionals, Lars E. Birgerson, M.D., Ph.D., vice president of medical affairs

at Roche, said that women of childbearing age should not be started on mycophenolate mofetil until a

negative pregnancy test is obtained.

He said women should be advised to use two methods of

birth control -- or total abstinence -- for four weeks prior to starting mycophenolate therapy and should continue contraception

or abstinence during treatment and for six weeks after stopping mycophenolate.

Other adverse events associated with the drug are neutropenia and gastrointestinal bleeding.

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