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Combined Hormonal Contraceptives and Venous Thromboembolism: Putting the Risks Into Perspective

Raymond, Elizabeth G. MD, MPH; Burke, Anne E. MD, MPH; Espey, Eve MD, MPH

doi: 10.1097/AOG.0b013e31825194ca
Current Commentary

To date, 13 studies have provided data on the risk of venous thromboembolism associated with combined oral contraceptives containing drospirenone or the norelgestromin-containing contraceptive patch. The studies varied in their conclusions about whether these methods are associated with higher risks than combined oral contraceptives containing other progestins: the primary reported measures of association (adjusted odds ratios, incidence rate ratios, or hazard ratios) ranged from 0.9 to 3.3. All of the studies had weaknesses in population selection, data validity or completeness, or analysis that may have led to biased or spurious findings. Venous thromboembolism is rare; if the contraceptive methods of interest do confer a higher risk of thromboembolism, only an additional 5–10 per 10,000 users per year would be affected. The important message for patients, clinicians, and policy makers is that the benefits of all contraceptive methods markedly outweigh their risks, primarily because they prevent pregnancy, an inherently hazardous condition. Product labels for hormonal contraceptives should emphasize their substantial health benefits and established safety.

Focusing on possible small safety differences between hormonal contraceptives containing various progestins distracts from the vital message that all contraceptives are highly beneficial to health.

From Gynuity Health Projects, New York, New York; and the Departments of Obstetrics and Gynecology, Johns Hopkins University, Baltimore, Maryland, and the University of New Mexico, Albuquerque, New Mexico.

All three authors were temporary voting members at the Joint Meeting of the Advisory Committee for Reproductive Health Drugs and the Drug Safety and Risk Management Advisory Committee, U.S. Food and Drug Association, December 8–9, 2011. This article is entirely the work of the three authors and does not reflect the views of either the Advisory Committees or the U.S. Food and Drug Administration.

Corresponding author: Dr. Elizabeth G. Raymond, Gynuity Health Projects, 15 East 26th Street, Suite 801, New York, NY 10010; e-mail: eraymond@gynuity.org.

Financial Disclosure Dr. Burke is a Nexplanon and Implanon (Merck) trainer. The other authors reported no potential conflicts of interest.

© 2012 by The American College of Obstetricians and Gynecologists. Published by Wolters Kluwer Health, Inc. All rights reserved.