Health and Medical News

Immunosuppressant Further Linked To Birth Defects

Health and Medical News - Transplants & Organ Donations
Thursday, 07 February 2008
A new study documents malformations seen in an infant born to a kidney transplant recipient who had taken mycophenolate mofetil (MMF), a broadly used immunosuppressant available commercially as Cellcept®. The findings suggest a special 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. Approximately 14,000 births to organ transplant recipients, primarily kidney transplant patients, have been reported worldwide. Although pregnancy was primarily ill-advised for these women, the American Society of Transplantation concluded in 2003 that pregnancy is generally safe following the first year of a transplant, provided that organ rejection or other difficulties have not happened. The fetal side-effects of several immunosuppressant drugs have been studied, though not for broadly used newer medications, like (MMF). The use of immunosuppressant drugs is a essential, life-long treatment for solid organ transplant recipients. They are used to prevent, inhibit or decrease the natural reaction of the immune system against foreign tissues. However, these drugs have meaningful side effects that sometimes prevent their use. The FDA divides immunosuppressants into four categories (A, B, C and D) regarding toxicity to the fetus. MMF has lately been upgraded to class D during pregnancy, meaning that its use is prevented for the high risk of fetal malformations. Immunosupressants are also given to women with severe autoimmune diseases, like generalized lupus. In fact, 3 out of 10 babies described in the literature regarding these defects had mothers on MMF owing to lupus nephritis. Led by Dr. Antonio Perez-Aytes and Dr. Maximo Vento of the Newborn Research Unit at the Hospital Universitario Materno-Infantil La Fe, in Valencia, Spain, the study describes a 25-year-old Spanish woman who had undergone 2 kidney transplants. Following the second transplant she took the immunosuppressant drugs tacrolimus and MMF. Two years later she became pregnant and MMF was discontinued at 10 weeks gestation, while tacrolimus, one of the drugs that has been studied in pregnant women, was maintained. She delivered a female infant who had cleft lip and palate, as well as defects of the jaw, eyes and ears, including no external ear canals. At nine months her child was developing generally, although she required hearing aids. The pattern of defects seen in this infant is very alike to preceding reports of birth defects in infants who were exposed to MMF in utero. The study describes these infants, noting that the pattern of cleft lip/palate and ear malformations was seen in every case but one. Although defects of the eye had not been seen in humans before, studies in rats and rabbits have shown ocular malformations following exposure to MMF. The authors suggest that the pattern of defects seen with MMF establishes a possible link between use of this drug during pregnancy and a special malformation pattern in structures derived from the frontal-nasal prominence (which develops into the forehead, nose, upper lip and palate) and the first pharyngeal arch (which develops into the jaw and ear). It should be noted, but, that if a transplant recipient is of fertile age, she can give birth to a healthful baby. "The patient requires to be adequately counseled, and withdraw from immunosuppressants that may be deleterious to the baby within sufficient of becoming pregnant to avoid any interference during the first 12 weeks of gestation," says Dr. Maximo Vento, co-author of the study. *"In Utero Exposure to Mycophenolate Mofetil: A Characteristic Phenotype?"* Antonio Perez-Aytes, Ana Ledo, Virginia boso, Pilar SÃ¡enez, Eva Roma, JosÃ© Luis Poveda, Maximo Vento American Journal of Medical Genetics Part A; January 2008. About Wiley InterScience Introduced in 1997 and launched commercially in January 1999, Wiley InterScience is a leading international resource for quality content promoting discovery across the spectrum of scientific, technical, medical and professional endeavors. In almost a decade, Wiley InterScience has built its reputation by regularly adding new content and functionality; offering sophisticated search and navigation capabilities; and providing robust online manuscript submission and management tools. Today, Wiley InterScience features must-have content from more than 2,500 journals, books, reference works, databases, laboratory manuals and the Cochrane Library, which is the world's best-known resource for evidence-based medicine. More than half of Wiley's journals on Wiley InterScience are digitized back to Volume 1, Issue 1 as part of the development of the journal backfile initiative. About Wiley Founded in 1807, John Wiley & Sons, Inc. has been a valued source of info and understanding for 200 years, helping people around the world meet their requires and fulfill their aspirations. Our core businesses comprise scientific, technical, medical, and scholarly journals, encyclopedias, books, and online products and services; professional/trade books, subscription products, training materials, and online products and services; and educational materials for undergraduate and graduate students and lifelong learners. Wiley's global headquarters are located in Hoboken, New Jersey, with operations in the U.S., Europe, Asia, Canada, and Australia. The Company's Web site can be accessed at http://www.wiley.com. The Company is listed on the New York Stock Exchange under the symbols JWa and JWb. John Wiley & Sons, Inc.

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