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Use of Statins by Pregnant Women

NEW YORK—November 21, 2008

Several recent news stories have highlighted the results of a research study (reported in the October 2008 issue of The Journal of Clinical Investigation [1]) on a mouse model of antiphospholipid syndrome-induced pregnancy loss in which a scientist at Hospital for Special Surgery, Guillermina Girardi, Ph.D., participated. These media reports could create the false impression that statins (cholesterol-lowering drugs such as Lipitor®, Zocor®, and Crestor® that are available only by prescription) are safe to take during pregnancy. They also might be read to suggest that a clinical study to test whether statins prevent pregnancy loss is currently in progress at HSS, or that such a study will commence in the near future.

Neither is true.

  • Statins are contraindicated during pregnancy. The U.S. Food and Drug Administration has labeled statins as pregnancy category X drugs, meaning that studies in animals or humans have demonstrated fetal abnormalities or there is evidence of fetal risk based on human experience, or both, and the risk clearly outweighs any possible benefit.
  • HSS is not currently studying the use of statins to prevent pregnancy loss in humans. HSS is currently studying the use of statins in antiphospholipid syndrome (APS), which can cause pregnancy loss, but pregnant women are not allowed to participate in that study – only people with other features of APS may take part. HSS is also conducting clinical research on APS and pregnancy loss, but none of those studies involve statins. (For more information about HSS’s current studies regarding APS, please visit our antiphospholipid syndrome listing of clinical trials on HSS.edu). While HSS may, in the future, pursue clinical studies to determine whether statins or similar drugs prevent pregnancy loss in humans, no such study is currently planned.

It is important to note that the study reported in these news stories was a proof-of-concept study in mice, not a clinical trial involving human subjects. While the mouse study does point to a new way of thinking about how pregnancies are lost, and may in the future point to a new type of treatment for APS-induced pregnancy loss, clinical studies are necessary before the use of statins during human pregnancy can be deemed safe.

Hospital for Special Surgery

Stephen A. Paget, M.D., FACP, FACR
Physician-in-Chief and Chairman of the Division of Rheumatology

Michael D. Lockshin, MD, MACR
Director, Barbara Volcker Center for Women and Rheumatic Disease
Co-Director, Mary Kirkland Center for Lupus Research

[1] Redecha P, et al: Neutrophil activation by the tissue factor/Factor VIIa/PAR2 axis mediates fetal death in a mouse model of antiphospholipid syndrome. J Clin Invest 2008 October 1; 118(10): 3453–3461.

 

About HSS | Hospital for Special Surgery
HSS is the world’s leading academic medical center focused on musculoskeletal health. At its core is Hospital for Special Surgery, nationally ranked No. 1 in orthopedics (for the eighth consecutive year) and No. 3 in rheumatology by U.S. News & World Report (2017-2018). Founded in 1863, the Hospital has one of the lowest infection rates in the country and was the first in New York State to receive Magnet Recognition for Excellence in Nursing Service from the American Nurses Credentialing Center four consecutive times. The global standard total knee replacement was developed at HSS in 1969. An affiliate of Weill Cornell Medical College, HSS has a main campus in New York City and facilities in New Jersey, Connecticut and in the Long Island and Westchester County regions of New York State. In 2017 HSS provided care to 135,000 patients and performed more than 32,000 surgical procedures. People from all 50 U.S. states and 80 countries travelled to receive care at HSS. In addition to patient care, HSS leads the field in research, innovation and education. The HSS Research Institute comprises 20 laboratories and 300 staff members focused on leading the advancement of musculoskeletal health through prevention of degeneration, tissue repair and tissue regeneration. The HSS Global Innovation Institute was formed in 2016 to realize the potential of new drugs, therapeutics and devices. The culture of innovation is accelerating at HSS as 130 new idea submissions were made to the Global Innovation Institute in 2017 (almost 3x the submissions in 2015). The HSS Education Institute is the world’s leading provider of education on the topic on musculoskeletal health, with its online learning platform offering more than 600 courses to more than 21,000 medical professional members worldwide. Through HSS Global Ventures, the institution is collaborating with medical centers and other organizations to advance the quality and value of musculoskeletal care and to make world-class HSS care more widely accessible nationally and internationally.

 

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