Home » Drug Information » FDA Approved Drugs » 2001
Medical Areas: Obstetrics/Gynecology (Women’s Health)
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The following drug information is obtained from various newswires, published
medical journal articles, and medical conference presentations.
Company: Ortho-McNeil Pharmaceutical
Approval Status: Approved November 2001
Treatment Area: Contraception
Ortho Evra is approved as a once-a-week contraceptive for women.
It is the first transdermal hormonal patch to be approved, as well
as the first non-invasive form of birth control that, when used
correctly, is 99 percent effective.
Ortho Evra is a one and three-quarter inch square patch that
must be applied to the lower abdomen, buttocks, upper torso, or
outer upper arm. A woman is able to swim, bathe, and exercise
without the patch coming off. Each patch is worn for seven days
before being replaced, for three weeks. The fourth week is
treatment free, as with oral contraceptives.
The approval of Ortho Evra is supported by data from clinical
trials, conducted in more than 3,000 women, that compared the patch
to oral contraceptives. When Ortho Evra is used correctly, the
chance of becoming pregnant is approximately one percent. This is
comparable to correct usage of the pill.
Adverse events associated with the use of Ortho Evra may include
(but are not limited to) the following:
- Breast symptoms
- Application site reaction
- Upper respiratory infection
- Menstrual cramps
- Abdominal pain
Mechanism of Action
Ortho Evra (norelgestromin/ethinyl estradiol) is a combination
contraceptive that acts through supression of gonadotropins. The
primary mechanism of action is the inhibition of ovulation, though
other alterations include changes in the cervical mucus and
endometrium. The patch delivers a steady flow of hormones through
the skin and into the bloodstream.
For additional information on Ortho Evra, please visit