FDA advisers stand behind Ortho Evra patch
ADELPHI, Maryland (Reuters) - Drug advisers recommended that the label for Johnson and Johnson's Ortho Evra birth control patch should be simplified to better explain the risk of blood clots.
Advisers to the Food and Drug Administration, in a sweeping 20 to three vote with one abstention on Friday, found the current label for Ortho Evra, the only contraceptive patch sold in the country, inadequately reflects the risks women face by using it.
However, the panel voted 19-5 that the patch's risks were nonetheless outweighed by its benefits, such as pregnancy prevention through a once-weekly application.
All commonly-used birth control pills increase women's chances of getting blood clots. The patch, approved in 2001, has been linked to an even higher risk as it contains a much greater amount of hormone estrogen than a pill.
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