Taking CellCept?

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Roche's

Organ-Rejection Drug CellCept Increases Risk Of Birth Defects, Miscarriage, FDA

Says

Article Date: 01 Nov 2007 - 1:00

PDT

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. 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 . 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.

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.

Roche sent a letter

to physicians explaining the new warnings. According to FDA, prehuman

trials of the drug found some signs of fetal defects.

Barb in Texas - Together in the

Fight, Whatever it Takes!

Son Ken (33) UC 91 - PSC 99 - Tx 6/21 & 6/30/07 @ Baylor in Dallas