TUESDAY, Oct. 30 (HealthDay News) -- The U.S. Food and Drug Administration and Roche warned physicians on Oct. 29 about the use of the immunosuppressive drug CellCept (mycophenolate mofetil) during pregnancy. The FDA has changed CellCept's pregnancy category from category C (risk of fetal harm cannot be ruled out) to category D (positive evidence of fetal risk).
The warning was prompted by increased evidence linking CellCept with an increased risk of first-trimester pregnancy loss and congenital malformations affecting the face, lip, palate and ears, and defects affecting the heart, esophagus and kidneys. The change in pregnancy category was prompted by post-marketing data on women exposed to CellCept during pregnancy, including data from the United States National Transplantation Pregnancy Registry.
The FDA recommends that all women of childbearing age undergo a negative serum or urine pregnancy test within one week of initiating CellCept therapy. The agency also recommends contraceptive counseling and use of effective contraception for all women of childbearing age -- including pubertal girls and peri-menopausal women -- who take the drug.
CellCept could theoretically reduce the effectiveness of birth control pills because it reduces blood levels of the hormones they contain, the agency adds.
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