Ortho Evra
Ortho Evra is a weekly prescription patch that releases hormones transdermally through the skin into the blood stream.Each week the patch is changed and put on a different part of the torso, shoulders, abdomen or buttocks, avoiding the breasts. The hormones released include:
* .75 mg ethinyl estradiol (an estrogen hormone)
6.00 mg norelgestromin (a progestin hormone)
Updated Ortho Evra® Label
On September 20, 2006, following the release of a study showing twice the blood clot risk with Ortho Evra® than with oral contraceptive pills, the FDA and Johnson & Johnson announced that the drug’s label would once again be updated.Previously, on November 10, 2005, the FDA and Johnson & Johnson updated the labeling for the Ortho Evra® contraceptive patch, warning healthcare providers and patients that this product exposes women to higher levels of estrogen than most birth control pills. The FDA said that women who use Ortho Evra® are exposed to 60 percent more estrogen than those who use the pill with 35 micrograms of estrogen, an increased exposure amount likely due to the transdermal delivery mechanism of the patch hormones and their absorption into the body. It is believed that this increased estrogen exposure increases the risk of blood clots and resulting complications.Ortho Evra’s® original label stated that the patch’s health risks including clotting were similar to those of oral contraceptives.