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.