Roche's organ-rejection drug CellCept increases risk of birth defects, miscarriage, FDA says

Oct 31 2007

FDA on Monday said Roche's organ-rejection drug CellCept increases the risk of birth defects and miscarriage during the first trimester of pregnancy, Reuters reports. CellCept prevents organ rejection among kidney, liver and heart transplant recipients.

FDA issued a new black box warning to the drug's label about the increased risk of ear and facial deformities -- as well as problems in limbs, the heart and other organs -- among fetuses and infants exposed to the drug (Reuters, 10/29). FDA cited National Transplantation Pregnancy Registry data published in December 2006 of 24 women who were exposed to CellCept. The women had a total of 33 pregnancies, of which 15 resulted in a miscarriage and 18 in a live birth. Among the 18 live births, four infants had birth defects, according to Dow Jones. According to postmarketing data, which were collected by Roche and involved 77 women who took CellCept, there were 25 miscarriages and 14 defects among fetuses and infants. Six of the defects were ear abnormalities (Corbett Dooren, Dow Jones, 10/29).

In addition, FDA said the drug, which is known generically as mycophenolate mofetil, might lower blood levels of the hormones in oral contraceptives, making the pills less effective at preventing pregnancy. FDA said women of childbearing age should have a negative pregnancy test within one week before beginning treatment with CellCept, receive birth control counseling and use effective contraception (AP/Google.com, 10/29).

Roche sent a letter to physicians explaining the new warnings (Dow Jones, 10/29). According to FDA, prehuman trials of the drug found some signs of fetal defects (Reuters, 10/29).