Novartis Drug Carries Pregnancy Risks

Drug maker Novartis has added new labeling about risks of birth defects and lost pregnancies to its organ-rejection treatment Myfortic.

The Food and Drug Administration alerted physicians and patients to the risks late Tuesday and said women who are planning a pregnancy should only use Myfortic if they have no other therapy options.

FDA requested the labeling change after reviewing data showing that women on Myfortic had more birth defects in their children and more failed pregnancies than women in the general population.

As part of the labeling change, FDA changed Myfortic's pregnancy code to indicate there is "positive evidence of fetal risk." Previously Myfortic was included in a category of drugs labeled: "risk of fetal harm cannot be ruled out."

FDA approved Myfortic in March 2004 to prevent organ rejection in kidney transplant patients.

Shares of Novartis AG fell 12 cents Wednesday to $56.53.