Novartis' Myfortic poses fetal risks--FDA
LOS ANGELES, Nov 27 (Reuters) - The U.S. Food and Drug Administration said on Tuesday that Novartis AG's (NOVN.VX) organ rejection drug, Myfortic, increases risk of first-trimester miscarriage and birth defects.
Novartis said in a letter to health-care providers that the drug will carry a new safety warning outlining the increased miscarriage risk and raised risk for malformations of the external ear and the face, such as cleft lip and palate.
Other drug-related birth defect risks include anomalies of distal limbs, which include fingers and toes, and of the heart, esophagus and kidney.
FDA said the warnings resulted from data collected from the United States National Transplantation Pregnancy Registry as well as postmarketing data collected from women who took the drug during pregnancy.
According to the FDA, women who are planning a pregnancy should not use Myfortic unless she cannot be successfully treated with other immunosuppressant drugs. Female patients of childbearing age must receive contraceptive counseling and must use effective contraception while taking Myfortic.
The agency last month warned that Roche Holding AG's (ROG.VX) organ rejection drug, CellCept, raises the risk of miscarriage in the first trimester and congenital malformations.
(Reporting by Lisa Baertlein; Editing by Gary Hill)
((lisa.baertlein@reuters.com; +1 213 955 6742; Reuters Messaging: lisa.baertlein.reuters.com@reuters.net)) Keywords: NOVARTIS MYFORTIC/
(C) Reuters 2007. All rights reserved. Republication or redistribution ofReuters content, including by caching, framing or similar means, is expresslyprohibited without the prior written consent of Reuters. Reuters and the Reuterssphere logo are registered trademarks and trademarks of the Reuters group ofcompanies around the world.nN27527364
