Roche's Organ-Rejection Drug CellCept Increases Risk Of Birth Defects

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Organ-Rejection Drug CellCept

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.

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

Inaddition, FDA said the drug, which is known generically asmycophenolate mofetil, might lower blood levels of the hormones in oralcontraceptives, making the pills less effective at preventingpregnancy. FDA said women of childbearing age should have a negativepregnancy test within one week before beginning treatment withCellCept, receive birth control counseling and use effectivecontraception (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).

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