born 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 two 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 normally, although she needed hearing aids.
The pattern of defects seen in this infant is very similar to previous 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 specific 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, however, that if a transplant recipient is of fertile age, she can give birth to a healthy baby. The patient needs 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.
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