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U.S. Department of Health and Human Services

Safety

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Ortho Evra (Norelgestromin/Ethinyl Estradiol) Transdermal Patch

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) – August 2012

Summary View

 

WARNINGS AND PRECAUTIONS

  • Five epidemiologic studiesare described below. These are 4 case control studies, that compared VTE rates among women using Ortho Evra to rates among women using an OC comparator, and an FDA-funded cohort study that estimated and compared VTE rates among women using various hormonal contraceptives, including Ortho Evra…
  • Some of the data from the epidemiologic studies suggest an increased risk of VTE with use of Ortho Evra compared to use of some combined oral contraceptives…
The five studies are:
  • The Boston Collaborative Surveillance Program… using only non-fatal idiopathic cases. VTE cases were not confirmed by chart review.
  • BCDSP with LNG-containing oral contraceptives as the comparator, based on the Pharmetrics database, using only non-fatal idiopathic cases. VTE cases were not confirmed by chart review.
  • BCDSP with LNG-containing oral contraceptives as the comparator, based on the Marketscan database, using only non-fatal idiopathic cases. VTE cases were not confirmed by chart review.
  • FDA-funded study with two groups of comparators [1) only LNG-containing oral contraceptives, and 2) oral contraceptives that contain LNG, norethindrone or norgestimate], based on Kaiser Permanente and Medicaid databases. This study included patient chart review to confirm the VTE occurrence.
 
Thromboembolic Disorders and Other Vascular Problems
Thromboembolism
  • An increased risk of thromboembolic and thrombotic disease associated with the use of combination hormonal contraceptives (CHCs) is well established. Case control studies have found Although the relative risk of absolute VTE rates are increased for users of CHCs compared to non-users, the rates associated with pregnancy are even greater, especially during the post-partum period.
  • The frequency of VTE in women using CHCs has been estimated to be 3 to 912 cases per 10,000 woman-years.
  • The risk of VTE is highest during the first year of use of hormonal contraception. The risk of thromboembolic disease due to combination hormonal contraceptives gradually disappears after use is discontinued.
  • Figure 6 shows the risk of developing a VTE for women who are not pregnant and do not use CHCs, for women who use CHCs, for pregnant women, and for women in the postpartum period.
  • To put the risk of developing a VTE into perspective: If 10,000 women who are not pregnant and do not use CHCs are followed for one year, between 1 and 5 of these women will develop a VTE.
  • A two- to four-fold… risk factors, such as smoking, obesity or family history of VTE…
  • If feasible, discontinue hormonal contraceptives 1) at least four weeks prior to and for two weeks after major surgery or other surgeries known to have an elevated risk of thromboembolism and 2) during and following prolonged immobilization.
 

PATIENT LABELING

Other Considerations Before Taking Ortho Evra
  • Like pregnancy, hormonal birth control methods increase the risk of serious blood clots, especially in women who have other risk factors, such as smoking, obesity, or age greater than 35 years. This increased risk is highest when you first start using hormonal birth control. Some studies have reported that women who use ORTHO EVRA® have a higher risk of getting a blood clot. Talk with your healthcare provider about your risk of getting a blood clot before deciding which type of birth control is right for you.
  • It is possible to die or be permanently disabled from a problem caused by a blood clot, such as a heart attack or a stroke. Some examples of serious clots are blood clots in the…