Today the FDA and drug maker Norvitas announced the transplant anti-rejection drug Myfortic has been confirmed to increase the risk of pregnancy loss and congenital malformations. Any patient that is or plans on becoming pregnant should not use Myfortic unless there is no other alternative for treatment. Myfortic has been placed in Category D, meaning there is positive evidence of fetal risk.
The new label comes as result of postmarketing data from the United States National Transplantation Pregnancy Registration. Data from women exposed to mycophenolate mofetil (MMF) also contributed to the decision, as MMF is converted to the active ingredient in Myfortic.
Physicians are urged to discuss potential risks and benefits of Myfortic and should also discuss alternative treatment options. Contraceptive counseling is required for females capable of bearing children. Patients taking Myforic are advised to contact their doctor for more information.
For more information on this subject, please refer to the section on Drugs, Medical Devices, and Implants.