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PRESS STATEMENT: Putting Risk Into Perspective: The Contraceptive Patch and New FDA Warning

Dr. Lee Shulman
In-Coming Chair, Board of Directors
Association of Reproductive Health Professionals (ARHP)

For Immediate Release
November 18,  2005

Ann McCall
(202) 466-3825

Recently the Food and Drug Administration (FDA) announced a label change for the adhesive, transdermal birth control patch marketed as OrthoEvra® by its manufacturer, Ortho-McNeil. The FDA is adding a “black box warning" that states the patch can lead to higher estrogen exposure than oral contraceptives but that the clinical relevance of this is "unknown."

Health care providers should closely follow this issue and help each patient understand the evidence-based factors that exist with this and all other treatments and conditions. Because the clinical relevance of this finding is not yet known, women using the patch may have concerns about starting or continuing this method of birth control. Clinicians should know that over 5 million women have used the patch since it was introduced in 2002, and that the health risks associated with patch use are seemingly the same as the risks of using other contraceptives containing estrogen.

It is disconcerting that a warning would be issued on this or any other method without sound clinical evidence of an increased risk for an adverse outcome. Taking oral contraceptives or using hormonal contraceptive patches slightly increases the risk of cardiovascular problems—especially for women over 35 who smoke. Deaths among young women because of medical problems such as blood clots and heart attacks are very rare, and they are also very rare among young women using contraceptive hormones. The rate for cardiovascular problems estimated for women using the patch is in the range that has been reported for other hormonal contraceptives such as oral contraceptives.

Until evidence-based research proves otherwise, it is the health care provider’s responsibility to ensure that their patients are fully informed about risks associated with hormonal contraception, including the patch, as well as risks associated with pregnancy, which are significantly greater. The failure to provide accurate clinical information to clinicians and consumers only serves to promote poor contraceptive choices and method misuse, and thus increases the likelihood of unintended pregnancy.


The Association of Reproductive Health Professionals (ARHP) is the leading source for trusted medical education and information on reproductive and sexual health. ARHP educates health care providers, informs consumers, and helps shape public policy. ARHP is a non-profit membership association composed of highly qualified and committed experts in reproductive health. ARHP members are health professionals in clinical practice, education, research, and advocacy and they include physicians, nurse practitioners, physician assistants, nurse midwives, researchers, educators, pharmacists, and other professionals in reproductive health. To learn more, visit: