CellCept, used by doctors to prevent organ rejection in transplant patients, may lower blood levels of the hormones in birth control pills, thus making them less effective at preventing pregnancy.
Manufactured by Switzerland's Roche Holding, the immune-system suppressing drug should only be used on women of childbearing potential if they have a negative pregnancy test within a week of starting the drug. Such women should also undergo birth control counseling and use effective contraception, the FDA said.
FDA has also changed the label warnings associated with Cellcept the most serious a drug can carry in a new package. FDA changed the drug's pregnancy code to reflect that it carries "positive evidence of fetal risk." Previously the drug's code merely stated that "fetal harm cannot be ruled out."
The updated labeling also stresses that women of childbearing age must use effective contraception while taking the drug. Pregnant women should only use CellCept if they cannot be treated with other immune-system suppressing drugs.
According to AP reports, Roche cited 25 miscarriages among 77 women exposed to the drug between 1995 and 2007. Fourteen of the women exposed to the drug had deformed babies or fetuses, hospital records show.
CellCept, which is generically known as mycophenolate mofetil, received federal approval in 1995 to prevent organ rejection in patients who have had kidney, heart or liver transplants.
