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Ciclosporin Use During Pregnancy

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Abstract

Ciclosporin (cyclosporine) is an immunosuppressive drug first approved for use in organ transplantation to prevent rejection. Ciclosporin is also known to be used for the treatment of psoriasis, rheumatoid arthritis, systemic lupus erythematosus and inflammatory bowel disease, among other indications. While it is recommended that all medications that are not absolutely necessary should be avoided during pregnancy, this may not be an option for many women whose quality of life is significantly impacted without treatment, or for those who must continue immunosuppressive therapy to avoid organ rejection. The purpose of this review is to provide a comprehensive report from the literature of ciclosporin exposure during pregnancy. PubMed, MEDLINE and the Cochrane Database of Systematic Reviews were searched for English-language articles published from 1970 to 2012 that included reports of pregnant women treated at any time during pregnancy with ciclosporin. On an initial search, it was evident that much of the available information is limited to pregnancy after transplant, which suggests that ciclosporin use during pregnancy appears to be associated with premature delivery and low birthweight infants. Comorbidities such as hypertension, pre-eclampsia and gestational diabetes mellitus are also reported at higher incidences than the general population. Medical literature concerning women with autoimmune disorders exposed to ciclosporin during pregnancy are currently limited to case reports and registry data, and, as such, it is difficult to determine if any risks associated with ciclosporin therapy during pregnancy are due to exposure to the drug alone or to pre-existing maternal comorbidities. The literature suggests that ciclosporin therapy during pregnancy should be carefully considered by the treating physician, but may be a safe alternative for patients with autoimmune disease refractory to conventional treatment. Continued monitoring of this patient population remains a key component to understanding the risk factors associated with ciclosporin exposure during pregnancy.

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The Neoral® Pregnancy Registry for Psoriasis and Rheumatoid Arthritis (NPR) is supported by a grant from Novartis Farmacéutica S.A., which was involved in the approval and review of the manuscript. The National Transplantation Pregnancy Registry (NTPR) has been supported by grants from Novartis Pharmaceuticals Corporation, Astellas Pharma US, Inc., Genentech, Inc., Pfizer Inc., Teva Pharmaceuticals USA, Sandoz Inc. and Bristol-Myers Squibb Company.

Conflicts of interest

Michael Moritz has been a prior participant on the Novartis Speakers Bureau. All other authors declare no conflicts of interest that are directly relevant to the content of this review.

Neoral® Pregnancy Registry for Psoriasis and Rheumatoid Arthritis

To contact the NPR to report additional pregnancies: Gift of Life Institute, 401 N. 3rd Street, Philadelphia, PA 19123, USA; Phone: Toll-free 001-888-522-5581; Email: npr.registry@giftoflifeinstitute.org; Website: http://www.npr.giftoflifeinstitute.org

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Authors and Affiliations

  1. Johns Hopkins Hospital, Baltimore, MD, USA

    Karolina Paziana

  2. Academy Dermatology, Moorestown, NJ, USA

    Magaly Del Monaco

  3. Cooper University Hospital, Camden, NJ, USA

    Elyce Cardonick

  4. Lehigh Valley Network, Allentown, PA, USA

    Michael Moritz

  5. Thomas Jefferson University, Philadelphia, PA, USA

    Matthew Keller & Bruce Smith

  6. Gift of Life Institute, 401 N. 3rd Street, Philadelphia, PA, 19123, USA

    Lisa Coscia & Vincent Armenti

Authors
  1. Karolina Paziana
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  2. Magaly Del Monaco
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  3. Elyce Cardonick
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  4. Michael Moritz
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  5. Matthew Keller
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  6. Bruce Smith
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  7. Lisa Coscia
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  8. Vincent Armenti
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Corresponding author

Correspondence to Vincent Armenti.

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Paziana, K., Del Monaco, M., Cardonick, E. et al. Ciclosporin Use During Pregnancy. Drug Saf 36, 279–294 (2013). https://doi.org/10.1007/s40264-013-0034-x

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  • DOI: https://doi.org/10.1007/s40264-013-0034-x

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