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Potential Increased Blood Clot Risk with Newest OCs

October 22, 2012

Washington, DC -- Birth control pills containing drospirenone may have a slightly higher risk of blood clots than other oral contraceptives (OC), but any increased risk remains very low, according to a new Committee Opinion released today by The American College of Obstetricians and Gynecologists (The College). In fact, the risk of developing blood clots with all OCs is significantly lower than the blood clot risk during pregnancy and in the month after giving birth. Women taking OCs containing drospirenone and doing well on them do not need to stop taking them.

 There are two basic types of OCs approved by the US Food and Drug Administration (FDA): combination pills containing both estrogen and progestin and progestin-only pills (the “mini-pill”). Several of the newer combination OCs contain a form of progestin known as drospirenone. Although birth control pills are safe for most women, one of the potential, but very low, risks with OCs is the development of blood clots.

According to data from the FDA, the blood clot risk among women who are not pregnant and not using combination OCs is 1–5 per 10,000 woman-years compared with a risk of approximately 3–9 per 10,000 woman-years among women using OCs. (A woman-year is a unit that represents 12 months of exposure to the risk of pregnancy.) Some recent studies reported a possible increased risk of blood clots with OCs containing drospirenone (5–10 per 10,000 woman-years) compared with other combination OCs; other studies have not found an increased risk. The risk of blood clots during pregnancy is higher at 5–20 per 10,000 woman-years. A woman’s highest risk of blood clots is during the immediate postpartum period (40–65 per 10,000 woman-years).

Several conditions are known to place women at high risk for blood clots if they are taking combination OCs. Those at high-risk include women age 35 and older who smoke; women who have hereditary thrombophilia, a history of blood clots or pulmonary embolism, inflammatory bowel disease, or lupus; women who have had major surgery requiring prolonged immobilization; or those who are less than 21 days postpartum (or 21–42 days postpartum with other risk factors). The risk of blood clots in these women usually outweighs the benefit of using combination OCs, and for some, the health risk of taking combination OCs is considered unacceptable.

Committee Opinion #540 “Risk of Venous Thromboembolism Among Users of Drospirenone-Containing Oral Contraceptive Pills” is published in the November 2012 issue of Obstetrics & Gynecology.

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Other recommendations issued in this month’s Obstetrics & Gynecology:

Committee Opinion #541 “Professional Relationships with Industry” (NEW!)
ABSTRACT: The American College of Obstetricians and Gynecologists (the College) has a long history of leadership in ensuring that its educational mission is evidence based and unbiased. A predecessor to this Committee Opinion was published in 1985, making the College one of the first professional associations to pro¬≠vide guidance on this issue. The College has continued to update the ethical guidance on physician interactions with industry periodically. Obstetrician–gynecologists’ relationships with industry should be structured in a manner that will enhance, rather than detract from, their obligations to their patients. The ideal behaviors set forth in this Committee Opinion will contribute toward maintaining patient trust in the specialty and avoiding conflicts of inter¬≠est by College members.

Committee Opinion #542 “Access to Emergency Contraception” (NEW!)
ABSTRACT: Emergency contraception includes contraceptive methods used to prevent pregnancy in the first few days after unprotected intercourse, sexual assault, or contraceptive failure. Although the U.S. Food and Drug Administration approved the first dedicated product for emergency contraception in 1998, numerous barriers to access to emergency contraception remain. The purpose of this Committee Opinion is to examine the barriers to the use of oral emergency contraception methods and to highlight the importance of increasing access.

Practice Bulletin #131 “Screening for Cervical Cancer” (Revised)
ABSTRACT: The incidence of cervical cancer in the United States has decreased more than 50% in the past 30 years because of widespread screening with cervical cytology. In 1975, the rate was 14.8 per 100,000 women. By 2008, it had been reduced to 6.6 per 100,000 women. Mortality from the disease has undergone a similar decrease from 5.55 per 100,000 women in 1975 to 2.38 per 100,000 women in 2008 (1). The American Cancer Society (ACS) estimates that there will be 12,170 new cases of cervical cancer in the United States in 2012, with 4,220 deaths from the disease (2). Cervical cancer is much more common worldwide, particularly in countries without screening programs, with an estimated 530,000 new cases of the disease and 275,000 resultant deaths each year (3, 4). When cervical cancer screening programs have been introduced into communities, marked reductions in cervical cancer incidence have followed (5, 6). New technologies for cervical cancer screening continue to evolve as do recommendations for managing the results. In addition, there are different risk–benefit considerations for women at different ages, as reflected in age-specific screening recommendations. The ACS, the American Society for Colposcopy and Cervical Pathology (ASCCP), and the American Society for Clinical Pathology (ASCP) have recently updated their joint guidelines for cervical cancer screening (7), and an update to the U.S. Preventive Services Task Force recommendations also has been issued (8). The purpose of this document is to provide a review of the best available evidence regarding screening for cervical cancer.

The American College of Obstetricians and Gynecologists (The College), a 501(c)(3) organization, is the nation’s leading group of physicians providing health care for women. As a private, voluntary, nonprofit membership organization of approximately 56,000 members, The College strongly advocates for quality health care for women, maintains the highest standards of clinical practice and continuing education of its members, promotes patient education, and increases awareness among its members and the public of the changing issues facing women’s health care. The American Congress of Obstetricians and Gynecologists (ACOG), a 501(c)(6) organization, is its companion organization. www.acog.org

 

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