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News Article Excerpt
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| January 19, 2008 |
Star-Ledger (NJ), "New label for Ortho
Evra birth control patch" |
The Food and Drug Administration yesterday
approved an updated label for Johnson & Johnson's Ortho Evra birth control
patch that gives heightened emphasis to the risk of serious blood clots
some women could face.
The label change was prompted by a study conducted by the Boston Collaborative
Drug Surveillance Program, which found that women who used the patch were
at higher risk of blood clots that form in the legs and lungs, a condition
known as venuous thromboembolism. An earlier study by the group found no
difference in the risk of clots between women who used the patch and those
who took birth control pills.
Women who use the patch face a 60 percent higher overall exposure to estrogen
than those who use oral contraceptives, according to the FDA. Higher estrogen
exposure has been linked to clot formation in some women. Those risks were
included in the existing label for the patch, but are now disclosed in bold
lettering.
Learn more
about the rights of women who have been injured or died as a result of taking
Ortho Evra. |
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