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      Update on the Teratogenicity of Maternal Mycophenolate Mofetil

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          Abstract

          Mycophenolic acid (MPA) products, namely mycophenolate mofetil and mycophenolate sodium, are immunosuppressive medications used to prevent rejection in solid organ transplant recipients and to treat various autoimmune disorders. Mycophenolate therapy is considered to be teratogenic based on observational studies of pregnancies exposed to MPA, which demonstrated an increased incidence of miscarriages in pregnancies exposed to MPA during their first trimester and a pattern of birth defects in the offspring of some pregnancies exposed to MPA. Herein, we have detailed case and series reports in a comprehensive literature review summarizing what is known to date regarding fetal exposure to MPA. Based on evidence from the literature, results of postmarketing surveillance, and information from registries such as the National Transplantation Pregnancy Registry in the United States, it is advised that pregnancy be avoided by women taking MPA. Preconception planning offers the opportunity to explore the alternatives to protect the mother, her transplanted organ, and minimize fetal risk. How to proceed in cases of unplanned pregnancies exposed to MPA in transplant recipients is a complex issue. Research involving large epidemiological studies is expected to be sparse as women heed the warnings about becoming pregnant on MPA. Published recommendations for managing MPA in women of childbearing potential include discontinuing the medication prior to conception, switching the MPA to another medication, or discontinuing the MPA when the pregnancy is discovered.

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          Most cited references57

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          A systematic review and meta-analysis of pregnancy outcomes in patients with systemic lupus erythematosus and lupus nephritis.

          Studies of the impact of systemic lupus erythematosus (SLE) and its pregnancy complications have yielded conflicting results. Major limitations of these studies relate to their small numbers of patients and retrospective designs. The aim of this study was to perform a systematic literature review of pregnancy outcomes in women with SLE and a meta-analysis of the association of lupus nephritis with adverse pregnancy outcomes. We searched electronic databases from 1980 to 2009 and reviewed papers with validity criteria. Random-effects analytical methods were used to evaluate pregnancy complications rates. Thirty-seven studies with 1842 patients and 2751 pregnancies were included. Maternal complications included lupus flare (25.6%), hypertension (16.3%), nephritis (16.1%), pre-eclampsia (7.6%), and eclampsia (0.8%). The induced abortion rate was 5.9%, and when excluded, fetal complications included spontaneous abortion (16.0%), stillbirth (3.6%), neonatal deaths (2.5%), and intrauterine growth retardation (12.7%). The unsuccessful pregnancy rate was 23.4%, and the premature birth rate was 39.4%. Meta-regression analysis showed statistically significant positive associations between premature birth rate and active nephritis and increased hypertension rates in subjects with active nephritis or a history of nephritis. History of nephritis was also associated with pre-eclampsia. Anti-phospholipid antibodies were associated with hypertension, premature birth, and an increased rate of induced abortion. In patients with SLE, both lupus nephritis and anti-phospholipid antibodies increase the risks for maternal hypertension and premature births. The presented evidence further supports timing of pregnancy relative to SLE activity and multispecialty care of these patients.
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            Good research practices for comparative effectiveness research: approaches to mitigate bias and confounding in the design of nonrandomized studies of treatment effects using secondary data sources: the International Society for Pharmacoeconomics and Outcomes Research Good Research Practices for Retrospective Database Analysis Task Force Report--Part II.

            The goal of comparative effectiveness analysis is to examine the relationship between two variables, treatment, or exposure and effectiveness or outcome. Unlike data obtained through randomized controlled trials, researchers face greater challenges with causal inference with observational studies. Recognizing these challenges, a task force was formed to develop a guidance document on methodological approaches to addresses these biases. The task force was commissioned and a Chair was selected by the International Society for Pharmacoeconomics and Outcomes Research Board of Directors in October 2007. This report, the second of three reported in this issue of the Journal, discusses the inherent biases when using secondary data sources for comparative effectiveness analysis and provides methodological recommendations to help mitigate these biases. The task force report provides recommendations and tools for researchers to mitigate threats to validity from bias and confounding in measurement of exposure and outcome. Recommendations on design of study included: the need for data analysis plan with causal diagrams; detailed attention to classification bias in definition of exposure and clinical outcome; careful and appropriate use of restriction; extreme care to identify and control for confounding factors, including time-dependent confounding. Design of nonrandomized studies of comparative effectiveness face several daunting issues, including measurement of exposure and outcome challenged by misclassification and confounding. Use of causal diagrams and restriction are two techniques that can improve the theoretical basis for analyzing treatment effects in study populations of more homogeneity, with reduced loss of generalizability.
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              The impact of increased lupus activity on obstetric outcomes.

              Systemic lupus erythematosus is associated with multiple adverse pregnancy outcomes. We examined the impact of disease activity on spontaneous abortions, perinatal mortality, preterm delivery, and birth weight. The study was designed to assess all pregnancies in a cohort of lupus patients who were observed prospectively from 1987 to 2002. At each visit, the physician's estimate of lupus activity was determined on a visual analog scale (high-activity lupus defined as a score of >or=2). Disease activity in each trimester was compared. We assessed the impact of high-activity lupus during pregnancy on gestational age, live birth rate, and small for gestational age babies. Potential confounders, including demographics of the women as well as maternal history of lupus, renal lupus, and antiphosphoplipid antibody syndrome, were analyzed through multivariate analysis. Two hundred sixty-seven pregnancies were observed. Of these, 229 (85.8%) resulted in a live birth. High-activity lupus occurred in 57 pregnancies (21%). Fewer pregnancies among women with high-activity lupus ended with live births (77% versus 88% of those with low-activity lupus; P = 0.063). Full-term delivery was achieved in 15 pregnancies (26%) among women with high-activity lupus, compared with 127 pregnancies (61%) achieving full-term in those with no or mild lupus activity (P < 0.001). High-activity lupus in the first and second trimesters led to a 3-fold increase in pregnancy loss (miscarriages and perinatal mortality). High-activity lupus during pregnancy leads to increased premature birth and a decrease in live births, with almost one-quarter of these pregnancies resulting in fetal loss. Pregnancies in lupus patients must be closely watched and treated during all trimesters to improve pregnancy outcomes.
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                Author and article information

                Journal
                J Pediatr Genet
                J Pediatr Genet
                10.1055/s-00029027
                Journal of Pediatric Genetics
                Georg Thieme Verlag KG (Stuttgart · New York )
                2146-4596
                2146-460X
                June 2015
                : 4
                : 2
                : 42-55
                Affiliations
                [1 ]National Transplantation Pregnancy Registry (NTPR), Gift of Life Institute, Philadelphia, Pennsylvania, United States
                [2 ]University of Central Florida College of Medicine, Orlando, Florida, United States
                [3 ]Department of Pharmacy Practice, Temple University School of Pharmacy, Philadelphia, Pennsylvania, United States
                [4 ]Department of Medicine, Temple University School of Medicine, Philadelphia, Pennsylvania, United States
                [5 ]Department of Surgery, Lehigh Valley Health Network, Allentown, Pennsylvania, United States
                [6 ]Department of Surgery, Morsani College of Medicine, University of South Florida, Tampa, Florida, United States
                Author notes
                Address for correspondence Lisa A. Coscia, RN, BSN, CCTC National Transplantation Pregnancy Registry (NTPR) Gift of Life Institute 401 N. 3rd Street, Philadelphia, PA 19123United States NTPR@ 123456giftoflifeinstitute.org
                Article
                14140
                10.1055/s-0035-1556743
                4944211
                27617117
                08d0acd5-f5f2-495e-867a-ec6cf9ad6a7b
                © Thieme Medical Publishers
                History
                : 31 March 2015
                : 01 April 2015
                Categories
                Review Article
                Prenatal Exposures and Short and Long Term Developmental Outcomes
                Guest Editors: Sura Alwan, PhD and Christina D. Chambers, PhD, MPH

                mycophenolate mofetil,mycophenolic acid,mycophenolate sodium,fetus,immunosuppression,teratogen,birth defect,transplantation,pregnancy

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