A new study documents malformations seen in an infant born to a kidney transplant recipient who had taken mycophenolate mofetil (MMF), a widely used immunosuppressant available commercially as Cellcept.
The findings suggest a specific birth defect pattern particular to this drug, reinforcing its potential to harm to the fetus. The study was published in the January 2008 issue of the American Journal of Medical Genetics, available online via Wiley InterScience at http://www3.interscience.wiley.com/journal/117869018/issue.
Approximately 14,000 births to organ transplant recipients, primarily kidney transplant patients, have been reported worldwide. Although pregnancy was initially ill-advised for these women, the American Society of Transplantation concluded in 2003 that pregnancy is usually safe following the first year of a transplant, provided that organ rejection or other complications have not occurred. The fetal side-effects of several immunosuppressant drugs have been studied, though not for widely used newer medications, such as (MMF).
The use of immunosuppressant drugs is a required, life-long treatment for solid organ transplant recipients. They are used to prevent, inhibit or reduce the natural reaction of the immune system against foreign tissues. However, these drugs have important side effects that sometimes preclude their use. The FDA divides immunosuppressants into four categories (A, B, C and D) regarding toxicity to the fetus. MMF has recently been upgraded to class D during pregnancy, meaning that its use is precluded for the high risk of fetal malformations. Immunosupressants are also given to women with severe autoimmune diseases, such as generalized lupus. In fact, 3 out of 10 babies described in the literature regarding these defects had mothers on MMF because of lupus nephritis.