Analysis of 100 pregnancy outcomes in women treated systemically with tacrolimus

Abstract

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.

Treating Psoriasis During Pregnancy: Safety and Efficacy of Treatments

“…Pregnancy in organ-transplanted women is associated with a high level of complications. Jain et al [45] reported on 27 pregnancies and found a surprisingly low incidence of maternal complications and, consistent with other studies [46,47], an incidence of preterm delivery and low birth weight similar to those described in other immunosuppressive agents. Due to the molecular size of calcineurin inhibitors, topical use results in poor systemic absorption [48] and is hence expected to be safe during pregnancy; however, due to the lack of human data the FDA has assigned it a pregnancy category C and topical corticosteroids are preferred.…”

Kidney transplantation during a twin pregnancy. Case report and review of the literature

“…Tacrolimus is considered to be a safe drug to use during pregnancy, without presenting any increase in malformation rate with its use. There are no digital defects related with this drug [17][18][19]. Another infant had two development defects: lingual thyroid and interatrial septum defect, and the third infant a pyeloureteral junction stenosis.…”

General Approach: Pre-pregnancy Assessment of the Rheumatic Disease Patient

“…In general, in addition to prednisone, immunosuppressive medications that are considered permissible during pregnancy include azathioprine and cyclosporine. Use of tacrolimus is increasingly considered an effective alternative for patients who fail azathioprine: studies from the transplant literature suggest safety and tolerability in pregnancy [ 14 ] and pilot studies suggest effi cacy for lupus nephirits [ 15 ], including a case report of successful treatment of lupus nephritis with tacrolimus during lupus pregnancy [ 16 ].…”