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HEALTH NEWS

FDA Orders Strong Warning for Birth Control Patch Label

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 12 November, 2005  16:23 GMT

ortho evra birth control patch warning
There's no medical reason for women to use the 'more dangerous Ortho Evra' rather than one of the 'older, better understood, and equally effective oral contraceptives,' says one expert.
The US Food and Drug Administration has ordered that a strong warning be added to the label on the popular Ortho Evra birth-control patch.

The FDA said the warning was needed to alert users of the patch that they're being exposed to higher estrogen levels than was previously revealed, putting them at increased risk of blood clots and other serious side effects, the Associated Press reported.

The warning, added to the patch label on Thursday, tells women using the patch that they're be exposed to about 60 percent more estrogen than what's found in typical birth-control pills.

Lawsuits Filed

Previously, the FDA and patch maker Ortho McNeil said that risks associated with the patch were expected to be similar to those associated with taking birth-control pills, the AP reported.

Several lawsuits have been filed against Ortho McNeil by families of women who suffered blood clots or died while using the patch.

Dr. Sidney Wolfe, director of Public Citizen's Health Research Group, said in a prepared statement that there's no medical reason for women to use the "more dangerous Ortho Evra" rather than one of the "older, better understood, and equally effective oral contraceptives."




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