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Drug & Device News
Ortho Evra Patch Users Cautioned
Since the FDA warned physicians and patients of newly discovered dangers from use of the Ortho Evra skin patch birth control method, client recruitment advertisements from attorneys have proliferated. Ortho Evra is a weekly prescription patch that releases ethinyl estradiol (an estrogen hormone) and norelgestromin (a progestin hormone) through the skin into the bloodstream. It was the first skin patch approved for birth control. The warning, given Nov. 14, explains that the patch delivers approximately 60% more estrogen to users than oral birth control medications, placing users at potentially greater risk for blood clotting problems, heart attack and stroke.
Dr. Sidney Wolfe, director of the Health Research Group of consumer advocate group Public Citizen, issued a statement following the FDA announcement. He pointed out that his organization had warned consumers on its Web site WorstPills.org that the patch was dangerous, 2 months before the FDA issued its statement. Said Dr. Wolfe, “The new warning by the U.S. Food and Drug Administration (FDA) belatedly acknowledges the increased dangers of using the drug. These dangers were noted by the FDA physician who reviewed the drug before the agency approved it. Despite the fact that the agency has now admitted that 'women who use Ortho Evra are exposed to about 60% more estrogen than if they were taking a typical birth control pill' — important because increased estrogen means increased risks — the agency still allowed the drug on the market and is stubbornly unwilling to ban it.”
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