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Rheumatology 2008 47(Supplement 3):iii28-iii31; doi:10.1093/rheumatology/ken168
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© The Author 2008. Published by Oxford University Press on behalf of the British Society for Rheumatology. All rights reserved. For Permissions, please email: journals.permissions@oxfordjournals.org

Update on safety during pregnancy of biological agents and some immunosuppressive anti-rheumatic drugs

M. Østensen1, M. Lockshin2, A. Doria3, G. Valesini4, P. Meroni5, C. Gordon6, A. Brucato7 and A. Tincani8

1Department of Rheumatology and Clinical Immunology and Allergology, University Hospital of Bern, Bern, Switzerland 2Joan and Sanford Weill College of Medicine of Cornell University, Barbara Volcker Center for Women and Rheumatic Disease, Hospital for Special Surgery, New York, USA 3Division of Rheumatology, Department of Clinical and Experimental Medicine, University of Padova, Padova 4Cattedra di Reumatologia, University ‘La Sapienza’, Rome 5Department of Internal Medicine, University of Milan, Allergy, Clinical Immunology & Rheumatology Unit, IRCCS Istituto Auxologico Italiano, Milan, Italy 6Rheumatology Research Group, Division of Immunity and Infection, The University of Birmingham, Birmingham, UK 7Department of Internal Medicine, Ospedali Riuniti, Bergamo 8Rheumatology and Clinical Immunology, Spedali Civili, University of Brescia, Brescia, Italy.

Correspondence to: M. Østensen, Department of Rheumatology and Clinical Immunology and Allergology, University Hospital of Bern, CH-3010 Bern, Switzerland. E-mail: monika.oestensen{at}insel.ch


   Abstract

A consensus paper concerning the interaction of anti-rheumatic drugs and reproduction was published in 2006, representing data collected during the year 2004 and 2005. Because of an increasing use of biological agents in women of fertile age, the information was updated for the years 2006 and 2007. Experts disagree whether TNF-inhibitors should be stopped as soon as pregnancy is recognized or may be continued throughout pregnancy. Pregnancy experience with abatacept and rituximab is still too limited to prove their safety for the developing fetus. They must be withdrawn before a planned pregnancy. LEF has not been proven to be a human teratogen. Registries of transplant recipients have shown that cyclosporin (CsA) and tacrolimus do not increase the rate of congenital anomalies, whereas mycophenolate mofetil (MMF) clearly carries a risk for congenital anomalies. Prophylactic withdrawal of drugs before pregnancy is mandatory for abatacept, rituximab, LEF and MMF. Data remain insufficient for gonadal toxicity of immunosuppressive drugs in men and for excretion of these drugs in human breast milk.

KEY WORDS: Pregnancy, Biological agents, Immunosuppressive drugs

Submitted 3 March 2008; Accepted 1 April 2008


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