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FDA: Myfortic Changed to Pregnancy Category D

Immunosuppressant drug linked with pregnancy loss and increased risk of fetal malformations

WEDNESDAY, Nov. 28 (HealthDay News) -- The U.S. Food and Drug Administration and Novartis announced this week that use of the immunosuppressant Myfortic (mycophenolic acid) delayed-release tablets is associated with increased risks of pregnancy loss and congenital malformations, and the pregnancy category for Myfortic has thus been changed from category C to category D, indicating evidence of fetal harm. Myfortic is used for prophylaxis of organ rejection in renal transplant patients, in combination with cyclosporine and corticosteroids.

This updated safety warning follows evidence of fetal risk observed in postmarketing studies and from the U.S. National Transplantation Pregnancy Registry. Myfortic is associated with an increased risk of first trimester pregnancy loss and an increased likelihood of congenital malformations, including external ear and facial abnormalities, and anomalies of the distal limbs, heart, esophagus and kidney.

Patients planning to become pregnant should not use Myfortic unless they are unable to be treated with other immunosuppressants. Health care providers should discuss the risks and benefits of Myfortic with patients, including counseling on effective contraception in women of childbearing age who are taking Myfortic. Two methods of contraception are indicated since Myfortic may reduce the effectiveness of oral contraceptive pills.

"To monitor fetal outcomes of pregnant women exposed to immunosuppressant drugs, including Myfortic, a National Transplantation Pregnancy Registry has been established. Physicians are encouraged to register patients by calling 1-877-955-6877," comments Dr. Stephen Cunningham, Chief Scientific Officer of Novartis, in a letter to health care providers.

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