What Is the Teratogenic Risk of Mycophenolate?

Abstract

Mycophenolate is often used in the management of systemic lupus erythematosus. It has often been associated with significant fetal embryopathy, including fetal loss and multiple anomalies. The Food and Drug Administration has directed that women should be counseled regarding this prior to initiating treatment with this drug. Isolated total anomalous pulmonary venous return (TAPVR) is a rare association seen with its use in pregnancy.

Keywords

mycophenolate mofetil - mycophenolate sodium - teratogen - embryopathy - congenital anomalies

• References

• 1 Hoeltzenbein M, Elefant E, Vial T , et al. Teratogenicity of mycophenolate confirmed in a prospective study of the European Network of Teratology Information Services. Am J Med Genet A 2012; 158A (3) 588-596
• 2 Cellcept product information. http://www.gene.com/medical-professionals/medicines/cellcept . Accessed October 26, 2016
• 3 Coscia LA, Armenti DP, King RW, Sifontis NM, Constantinescu S, Moritz MJ. Update on the teratogenicity of maternal mycophenolate mofetil. J Pediatr Genet 2015; 4 (2) 42-55
• 4 Perez-Aytes A, Marin-Reina P, Boso V, Ledo A, Carey JC, Vento M. Mycophenolate mofetil embryopathy: a newly recognized teratogenic syndrome. Eur J Med Genet 2016; 7212 (16) 30318-30324
• 5 Food and Drug Administration. www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm148735.htm . Accessed October 26, 2016
• 6 Risk Evaluation and Mitigation Strategy. https://www.mycophenolaterems.com . Accessed October 26, 2016
• 7 Chang C. Unmet needs in the treatment of autoimmunity: from aspirin to stem cells. Autoimmun Rev 2014; 13 (04/05) 331-346
• 8 Pérgola PE, Kancharla A, Riley DJ. Kidney transplantation during the first trimester of pregnancy: immunosuppression with mycophenolate mofetil, tacrolimus, and prednisone. Transplantation 2001; 71 (7) 994-997
• 9 Le Ray C, Coulomb A, Elefant E, Frydman R, Audibert F. Mycophenolate mofetil in pregnancy after renal transplantation: a case of major fetal malformations. Obstet Gynecol 2004; 103 (5 Pt 2): 1091-1094
• 10 Sifontis NM, Coscia LA, Constantinescu S, Lavelanet AF, Moritz MJ, Armenti VT. Pregnancy outcomes in solid organ transplant recipients with exposure to mycophenolate mofetil or sirolimus. Transplantation 2006; 82 (12) 1698-1702
• 11 Perez-Aytes A, Ledo A, Boso V , et al. In utero exposure to mycophenolate mofetil: a characteristic phenotype?. Am J Med Genet A 2008; 146A (1) 1-7
• 12 Ang GS, Simpson SA, Reddy AR. Mycophenolate mofetil embryopathy may be dose and timing dependent. Am J Med Genet A 2008; 146A (15) 1963-1966
• 13 Jackson P, Paquette L, Watiker V, Randolph L, Ramanathan R, Seri I. Intrauterine exposure to mycophenolate mofetil and multiple congenital anomalies in a newborn: possible teratogenic effect. Am J Med Genet A 2009; 149A (6) 1231-1236
• 14 Parisi MA, Zayed H, Slavotinek AM, Rutledge JC. Congenital diaphragmatic hernia and microtia in a newborn with mycophenolate mofetil (MMF) exposure: phenocopy for Fryns syndrome or broad spectrum of teratogenic effects?. Am J Med Genet A 2009; 149A (6) 1237-1240
• 15 Lin AE, Singh KE, Strauss A, Nguyen S, Rawson K, Kimonis VE. An additional patient with mycophenolate mofetil embryopathy: cardiac and facial analyses. Am J Med Genet A 2011; 155A (4) 748-756
• 16 Klieger-Grossmann C, Chitayat D, Lavign S , et al. Prenatal exposure to mycophenolate mofetil: an updated estimate. J Obstet Gynaecol Can 2010; 32 (8) 794-797
• 17 Mohamed-Ahmed O, Nelson-Piercy C, Bramham K , et al. Pregnancy outcomes in liver and cardiothoracic transplant recipients: a UK national cohort study. PLoS One 2014; 9 (2) e89151 . Doi: 10.1371/journal.pone.0089151
• 18 Martín MC, Cristiano E, Villanueva M , et al. Esophageal atresia and prenatal exposure to mycophenolate. Reprod Toxicol 2014; 50: 117-121
• 19 King RW, Baca MJ, Armenti VT, Kaplan B. Pregnancy outcomes related to mycophenolate exposure in female kidney transplant recipients. . Am J Transplant 2016;