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US FDA warns about J&J patch hormone levels

Nov 10, 2005

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 warned on Thursday.

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.

"Women taking or considering using this product should work with their health care providers to balance the potential risks related to increased estrogen exposure against the risk of pregnancy if they do not follow the daily regimen associated with typical birth control pills," the agency said.

Representatives for J&J's Ortho McNeil Pharmaceuticals unit, which makes the patch, could not be immediately reached for comment.

Ortho McNeil is conducting studies comparing the blood clot risk in women using its patch compared to 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 said.

Ortho Evra, the first contraceptive patch on the U.S. market, releases the estrogen hormone ethinyl estradiol and a progestin hormone norelgestromin into the blood stream through the skin.

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