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New Warning Labels for Ortho Evra Contraceptive Patch

November 12, 2005

Birth Control • Ortho-Evra Patch Should Be Withdrawn: Public Citizen • Contraceptive Pill May Help Conception • Birth Control Pill Linked to Heart Disease • New Contraceptive Eliminates Women’s Periods • FDA Approves OTC Sales of Plan B • Wal-Mart Agrees to Stock Plan B in Connecticut Stores • Wal-Mart to Begin Dispensing "Morning After" Pill This Week • FDA: Birth Control Patch Needs More Study • Little Risk with Today's IUDs • Wal-Mart May Stock "Emergency" Contraceptives • New Warning Labels for Ortho Evra Contraceptive Patch • Feds Toughen Warning for Depo-Provera

The Food and Drug Administration has approved updated labeling warning that the Ortho Evra contraceptive patch exposes women to higher levels of estrogen than most birth control pills. Ortho Evra was the first skin patch approved for birth control.

It is a weekly prescription patch that releases an estrogen hormone and a progestin hormone, through the skin into the blood stream. FDA advises women to talk to their doctor about whether the patch is the right method of birth control for them.

“Furthermore, 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 in a release.

“Because Ortho Evra is a patch that is changed once a week, it decreases the chance associated with typical birth control pills that a woman might miss one or more daily doses.”

The addition of the new warning is a result of analyses comparing the levels for estrogen and progestin hormones in users of Ortho Evra with those in a typical birth control pill.

In general, increased estrogen exposure may increase the risk of blood clots. However, it is not known whether women using Ortho Evra are at a greater risk of experiencing these serious adverse events.

FDA said it is continuing to monitor safety reports for the Ortho Evra patch. The manufacturer, Ortho McNeil Pharmaceuticals, is conducting additional studies to compare the risk of developing serious blood clots in women using Ortho Evra to the risk in women using typical birth control pills that contain 35 micrograms of estrogen.

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