ADELPHI, MD. – Advisors to the Food and Drug Administration on Dec. 9 voted 19 to 5 that the benefits of the Ortho Evra contraceptive patch outweighed its risks, although they agreed with epidemiologic evidence that use of the patch is associated with an increased risk of venous thromboembolic events.
At a joint meeting of the FDA’s Reproductive Health Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee, panelists agreed that the risk of venous thromboembolic events (VTEs) associated with the Ortho Evra patch was greater than the VTE risk associated with combination oral contraceptives (COCs) that contain 35 mcg or less of ethinyl estradiol. But those who agreed that Ortho Evra had a favorable risk-benefit profile cited the unique features that the patch provides women, since it is the only contraceptive patch available in the United States and is an alternative to having to take a daily pill, and that it was important for women to have a range of contraceptive options available.
The majority of the panel also agreed that information about the risk-benefit profile of Ortho Evra in the prescriber and patient labels should be improved, and recommended revisions to the labels to reflect the available risk-benefit data, including the results of an FDA-funded study that found the risk of VTEs was increased in Ortho Evra users.
Ortho Evra was approved in November 2001 and contains 6 mg of norelgestromin and 750 mcg of ethinyl estradiol in a patch that is worn for 3 weeks, followed by 1 patch-free week. Exposure to ethinyl estradiol with the patch is about 60% higher than a COC containing 35 mcg of ethinyl estradiol.
Postmarketing reports of thrombotic and thromboembolic events associated with Ortho Evra appeared to be higher than rates with some COCs, so the manufacturer, Janssen Research and Development LLC, conducted two epidemiologic studies using insurance claims databases. One found the risk of VTEs was about twofold higher in women on Ortho Evra, compared with those on a COC containing norgestimate and 35 mcg of ethinyl estradiol. The other study found no increased VTE risk.
Earlier this year, a boxed warning was added to the Ortho Evra label that advises clinicians to balance the higher estrogen exposure with the patch and the "possible increased risk of VTE with the patch, against the chance of pregnancy."
The FDA-funded study, reported in October 2011, using an insurance claims database found that use of Ortho Evra was associated with about a 50% increased risk of VTEs, compared with combined hormonal contraceptives.
The FDA usually follows the recommendations of its advisory panels, which are not binding. Panelists have been cleared of potential conflicts of interest related to the topic of the meeting. Occasionally, a panelist may be given a waiver, but not at this meeting.