The U.S. Food and Drug Administration (FDA) has ordered Ortho McNeil, Inc., makers of the Ortho Evra birth-control patch, to add a label warning users that they are being exposed to estrogen levels far higher than initially reported. The company has cooperated with the FDA by adding a warning stating that users of the patch are exposed to 60 percent more estrogen than is found in birth control pills. Higher estrogen levels put users at increased risk for blood clots and other serious side effects.

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