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| T01-58 | Print Media: 301-827-6242 |
| November 20, 2001 | Consumer Inquiries: 888-INFO-FDA |
The Food and Drug Administration (FDA) today announced approval of Ortho Evra, the first transdermal (skin) patch approved for birth control. The weekly prescription patch releases norelgestromin (a progestin hormone), and ethinyl estradiol (an estrogen hormone), through the skin into the blood stream to prevent pregnancy.
Ortho Evra, an alternative to birth control pills, is a one-and-three-quarter inch square patch consisting of three layers. The hormones are embedded in the adhesive layer and are slowly released when the patch is applied to the skin.
Women who choose to use the product should apply it to the lower abdomen, buttocks
or upper body but not to the breasts. Each patch should be worn continuously
for one week and should then be replaced with a new patch on the same day of
the week for a total of three weeks of patch wear.
The fourth week, which is patch-free, allows a woman to have her menstrual period - similar to the regimen for birth control pills.
Like birth control pills, Ortho Evra is effective for prevention of pregnancy when used as directed. The risks of using this product are similar to the risks of using birth control pills including an increased risk of blood clots, heart attack, and stroke. The labeling also carries the warning that cigarette smoking increases the risk of serious cardiovascular side effects from use of combination hormonal contraceptives.
Three clinical trials conducted worldwide involved 4578 women of whom 3319 used Ortho Evra. The other women in the trials used birth control pills. The trials demonstrated that women using Ortho Evra were able to adhere to the once a week dosing regimen as an alternative to a daily dose of birth control pills .
In clinical trials, the product appeared to be less effective in women weighing
more than 198 pounds. About five percent of women had at least one patch that
did not stay attached to their skin. About two percent of women in the studies
withdrew from the clinical trial due to skin
irritation from the patch.
RW Johnson based in New Jersey will manufacture and market Ortho Evra. The
company will sell the product in packages of three patches for the monthly cycle
of use. Packages of a single replacement patch are also available for use if
a patch comes off before it is due to be changed.
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