MONDAY, Jan. 21 (HealthDay News) --
The U.S. Food and Drug Administration (FDA) has approved updated label information for the Ortho Evra contraceptive skin patch to incorporate the results of new study findings that suggest users of the patch may be at higher risk of developing serious blood clots, according to an FDA statement released Jan. 18.
The label change is based on a study conducted by the Boston Collaborative Drug Surveillance Program on behalf of Johnson and Johnson, which manufacturers Ortho Evra through its Ortho McNeil Pharmaceuticals division. The study compared the risk of nonfatal venous thromboembolism (VTE) among Ortho Evra users with the risk among users of oral contraceptive pills containing 35 micrograms of ethinyl estradiol and the progestin levonorgestrel. The results showed an approximately twofold greater risk for VTE among the Ortho Evra users.
The FDA had previously revised the label for Ortho Evra after another study found that some women were at a twofold greater risk of developing VTE. A third study found that some women using the Ortho Evra patch were not at greater risk of blood clots than women using birth control pills containing 30 to 35 micrograms of estrogen and the progestin norgestimate.
"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.
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