FDA Issues Warning on JJ Contraceptive Patch

//November 11, 2005//

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The new labeling for the patch will include information about the higher levels of estrogen.The Ortho Evra contraceptive patch, produced by Ortho McNeil Pharmaceuticals, a unit of Johnson & Johnson (NYSE: JNJ), contains higher levels of a hormone known to cause blood clots than average birth control pills, the U.S. Food and Drug Administration announced late Thursday night. The regulator said that 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 at increased risk for clots.

Higher estrogen exposure may increase the risk of side effects, including blood clots, strokes and heart attacks, Raritan-based Ortho-McNeil said today in a statement.

Ortho McNeil is conducting studies comparing the blood clot risk in women using its patch compared with those taking typical birth control pills containing 35 micrograms of estrogen, the FDA said. The agency will also continue to monitor for safety problems, it added. J&J shares slipped $0.32 to $61.09 in early trading.

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