Analysis of 100 pregnancy outcomes in women treated systemically with tacrolimus.
The aim of this paper is to provide a summary of clinical findings regarding the safety of tacrolimus in pregnancy. From 1992 to 1998 data were collected on 100 pregnancies from 84 mothers who received tacrolimus systemically; 83 cases of solid organ transplantation, and 1 case of Behçet's disease. Maternal mean age at conception was 28 years and pregnancy outcome was live birth in 68%, spontaneous abortion in 12%, induced abortion in 12%, stillbirth/perinatal death in 3%, ongoing pregnancy in 2%, and lost to follow up in 3%. Fifty-nine percent of the neonates were delivered prematurely (< 37 weeks of gestation). Birth weight was appropriate for the gestational age in 90% of the cases. Malformations occurred in 4 neonates: case 1, meningocele and urogenital defects; case 2, alcoholic embryopathy; case 3, ear defect, cleft palate and hypospadia; case 4, multicystic dysplastic kidney. There was no consistent pattern of malformations and 2 mothers subsequently delivered a healthy neonate while on tacrolimus therapy. Nearly 70% of pregnancies following systemic tacrolimus administration resulted in a favourable outcome without any significant effect on intrauterine growth. The incidence of malformations was similar to that reported with other immunosuppressants in transplant recipients.
Kainz
A
A
Fujisawa, Munich, Germany. alexander.kainz@fujisawa.de
Harabacz
I
I
Cowlrick
I S
IS
Gadgil
S
S
Hagiwara
D
D
D000293:Adolescent; D000328:Adult; D001528:Behcet Syndrome / Q000188:drug therapy; D001724:Birth Weight; D000013:Congenital Abnormalities / Q000145:classification / Q000453:epidemiology; D005260:Female; D005865:Gestational Age; D006801:Humans; D007166:Immunosuppressive Agents / Q000627:therapeutic use*; D007231:Infant, Newborn; D007234:Infant, Premature; D016030:Kidney Transplantation / Q000276:immunology; D016031:Liver Transplantation / Q000276:immunology; D011247:Pregnancy; D011248:Pregnancy Complications / Q000188:drug therapy; D011256:Pregnancy Outcome; D012189:Retrospective Studies; D016559:Tacrolimus / Q000627:therapeutic use*; D014181:Transplantation Immunology
D007166:Immunosuppressive Agents; D016559:Tacrolimus