FDAnews Device Daily Bulletin

FDA WARNS ABOUT ORTHO EVRA PATCH

Nov. 14, 2005
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Johnson & Johnson's Ortho Evra contraceptive patch contains higher levels of a hormone known to cause blood clots than average birth control pills, U.S. regulators recently warned. The U.S. Food and Drug Administration said new labeling for the patch will include information about the higher levels of estrogen, but that it was not clear whether women using the once-a-week product were more at risk for clots. Women who use Ortho Evra are exposed to 60 percent more estrogen than those who use the pill, the FDA said in a statement. But the pills, which contain several variations with different hormone levels for use during one month, can contain a higher maximum amount of estrogen.
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