FDA Approves Contraceptive Patch

First Transdermal Combination Hormone Birth Control Patch

The contraceptive patch, Ortho Evra is an alternative to daily birth control pills. It is a one-and-three quarter inch square patch made of three layers with the hormones embedded in the adhesive layer being slowly released when the patch is applied to the skin.

Ortho Evra can be worn on the lower abdomen, buttocks, or upper body (with the exception of the breasts where it should never be worn). Each contraceptive patch should be worn 24 hours a day for 7 days; it should be replaced on the same day of the week, and worn for three weeks. During the fourth patch-free week menstruation should occur.

The risks of Ortho Evra are similar to those associated with the use of oral contraceptives and include an increased risk of blot clots, heart attacks, or stroke. Women who smoke should be aware of the increased risk of serious cardiovascular side effects associated with the use of combination hormonal contraceptives.

In clinical trials, most women found it easy to stick to the weekly patch-changing regimen as an alternative to daily birth control pills.

Ortho Evra is effective for prevention of pregnancy when used as directed. However, it should be noted that women, in clinical trials, who weighed more than 198 pounds found the patch less effective; approximately 5% of women experienced difficulty with at least one patch adhering to their skin, and about 2% withdrew from the trials due to skin irritation from the contraceptive patch.

Ortho Evra will be manufactured and marketed by RW Johnson of New Jersey. Ortho Evra will be sold in packages of three patches, and in single packages for replacement should a patch come off before it is time to be changed.

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