Roche's Cellcept linked by FDA to increased miscarriage, birth defects

ZURICH (Thomson Financial) - Roche Holdings AG's CellCept drug could increase the risk of miscarriage in first trimester pregnancy and of birth defects, the Food and Drug Administration (FDA), the US health regulator, has warned on its website.

The FDA said the pregnancy warning for the drug has been lifted to category D, which indicates there is positive evidence of foetal risk.

CellCept is prescribed to prevent organ rejection by patients who have undergone kidney, heart or liver transplants.

Within a week of beginning therapy with the drug, women in childbearing potential age should have a negative serum or urine pregnancy test, it said.

In addition, these women must receive contraceptive counselling and use effective contraception. [e-mail] hmn/wj COPYRIGHT Copyright Thomson Financial News Limited 2007. All rights reserved. The copying, republication or redistribution of Thomson Financial News Content, including by framing or similar means, is expressly prohibited without the prior written consent of Thomson Financial News.