The Ortho Evra Contraceptive Transdermal (skin) Patch now has additional changes to its label. The U.S. Food and Drug Administration approved the changes as a result of a new epidemiology study that stated the users of the patch were at a higher risk for developing serious blood clots, known as venous thromboembolism (VTE) than women using birth control pills.
"For women that choose to use contraceptives, it is important that they thoroughly discuss with their health care providers the risks and benefits involved," said Janet Woodcock, M.D., the FDA's deputy commissioner for scientific and medical programs, chief medical officer, and acting director of the Center for Drug Evaluation and Research.
"This is an example of FDA working in tandem with the drug manufacturer to keep the public informed of new safety data and epidemiological studies that may impact health decisions about the use of FDA approved products."
The current label changes update previous changes from September 2006 when the FDA revised the Ortho Evra label to warn of the risk of VTE. That warning was based on two studies. One which showed no increased risk and one that showed that some women were at a two-time greater risk of developing VTE.
Ortho Evra is a prescription patch that releases ethinyl estradiol, an estrogen hormone, and norelgestromin, a progestin hormone, through the skin into the blood stream. Due to the fact that the hormones are processed differently than the hormones in birth control pills, woman using the patch are exposed to 60% more estrogen than the pills and thus are at an increased risk of side effects.
The FDA states that it believes 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."
[Source: FDA]
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