Update to Label On Birth Control Patch
The FDA has approved additional changes to the label for the Ortho Evra Birth Control Patch to include a warning that Higher levels of estrogen may increase risk of serious blood clots for some women.
According to a new clinical study completed in January 2008, users of the transdermal contraceptive patch have a higher risk of developing serious blood clots than women who use birth control pills such as Ortho Tricyclen, Yaz, or Lybrel.
Also known as venous thromboembolism (VTE), these blood clots can lead to pulmonary embolism (a blockage in an artery in the lung).
The Ortho Evra Contraceptive Patch is manufactured by Ortho McNeil Pharmaceuticals, a division of Johnson and Johnson. The label changes are based on a clinical study conducted at the drug maker’s request. The study included women aged 15-44, and the conclusions support a 2005 research study which also found that women in this group were at higher risk for venous thromboembolism.
Ortho Evra was the first transdermal patch approved for birth control. Applied to the skin once a week, Ortho Evra is a prescription patch that releases an estrogen hormone and a progestin hormone into the blood stream. Because these two hormones are processed by the body differently than hormones from oral contraceptives, women who use Ortho Evra are exposed to about 60 percent more total estrogen in their blood than if they were taking a typical birth control pill containing 35 micrograms of estrogen. These increased levels of estrogen may increase the risk of side effects, including VTE. Women who are considering the birth control patch are advised to discuss this possible increased risk of blood clots with their doctor.
The FDA is plans to continue to monitoring safety reports for the Ortho Evra patch. In a statement released today, the FDA says, “Ortho Evra is a safe and effective method of contraception when used according to the labeling, which recommends that women with concerns or risk factors for serious blood clots talk with their health care provider about using Ortho Evra versus other contraceptive options.”
