FDA Reposts Warning About Pregnancy-Related Risks Associated With Organ Transplant Drugs

Main Category: Pregnancy / Obstetrics
Also Included In: Transplants / Organ Donations
Article Date: 21 May 2008 - 7:00 PDT

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FDA on Friday reposted a notice warning that Roche and Novartis drugs prescribed for organ transplant recipients could cause miscarriages and birth defects when used by pregnant women and urged doctors to confirm that transplant patients are not pregnant and are using effective contraception, the AP/Google.com reports. Roche's CellCept and Novartis' Myfortic are used to suppress the body's immune system to avoid organ rejection in people undergoing transplant surgery.

FDA first issued the warning in October 2007. Agency spokesperson Christopher Kelly said that FDA has not received any new reports of pregnancy-related complications but that it was concerned that some physicians might not have seen the initial warning. FDA said most of the reported problems came from women who were taking CellCept before they knew they were pregnant. Some of the women were taking the drug for conditions it was not approved to treat, including rheumatoid arthritis and lupus. A spokesperson for Roche said the company has not received any new reports of miscarriages or birth defects since updating the drug's labeling (Perrone, AP/Google.com, 5/16).

When FDA issued the initial warning, it cited National Transplantation Pregnancy Registry data published in December 2006 of 24 women 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 postmarketing data, which were collected by Roche and involved 77 women who took CellCept, there were 25 miscarriages and 14 birth defects among fetuses and infants (Daily Women's Health Policy Report, 10/31/07).

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