Novartis and the Food and Drug Administration informed healthcare professionals and patients that use of Myfortic Delayed-Release Tablets during pregnancy increases the risks or pregnancy loss and congenital malformations.

Any woman who is pregnant or plans to get pregnant should not use this medication, unless there is no other alternative for treatment.

Myfortic has been categorized in D class, which means there is positive evidence of fetal risk.

This change follows data from the United States National Transplantation Pregnancy Registry and data collected from women taking the drug during pregnancy, which showed that the exposure to mycophenolate mofetil (MMF) was related to miscarriages and malformations.

Myfortic helps to prevent the body’s natural rejection of transplanted kidney and it is used for oral and intravenous administration.

Novartis said in a letter to healthcare providers that the drug would carry a new safety warning stressing the increased miscarriage risk and malformations of the external ear and the face, such as cleft lip and palate.

Other malformation risks related to using this drug are anomalies of distal limbs, which include fingers and toes, and of the heart, esophagus and kidney.

Doctors are urged to discuss the potential risks and benefits of Myfortic and should discuss alternative treatment options with their patients. Women capable of bearing children should receive contraceptive counseling if they are using the drug.

The health agency also warned that another organ rejection drug, CellCept, produced by Roche Holding AG’s raises the risk of miscarriage in the first trimester and congenital malformations.