Safety alert
date: 11/17/2005
Contraceptive patch warning: What it means
The
contraceptive patch exposes women to more estrogen than previously
thought. For women who can remember to take the birth-control pill
every day, it may be the more prudent choice.
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What should women who use the Ortho Evra contraceptive
patch do now that the manufacturer and the Food and Drug Administration
have announced a new label warning that the product exposes women to more
estrogen than most birth-control pills?
Ortho Evra works by delivering the pregnancy-preventing hormones estrogen and progestin directly through the skin into the bloodstream (in contrast to the birth-control pill, which must first be digested). A new bold-faced warning on the official label says that women who use the patch will be exposed to about 60 percent more estrogen overall than if they used a typical birth-control pill. The Nov. 10 warning followed an analysis by the FDA and the manufacturer of Ortho Evra, Ortho McNeil Pharmaceuticals, that compared blood levels of estrogen and progestin over three weeks in women using the patch with those on a typical birth-control pill.
In general, increased estrogen exposure from oral contraceptives is associated with an increased risk of rare but serious side effects, including blood clots in the leg veins, which can break off and become lodged in the lungs. It's not yet known whether the greater exposure to estrogen from Ortho Evra translates into a higher risk of clots. Despite news reports over the past year alleging that women on the patch suffer serious adverse events more often than women taking standard birth-control pills, studies thus far have not established any increased risk.
Approved by the FDA in 2002, the patch is worn on the buttocks, abdomen, upper torso, or arm and changed just once a week. It's the first and only birth-control patch on the market.
The warning
Ortho Evra works by delivering the pregnancy-preventing hormones estrogen and progestin directly through the skin into the bloodstream (in contrast to the birth-control pill, which must first be digested). A new bold-faced warning on the official label says that women who use the patch will be exposed to about 60 percent more estrogen overall than if they used a typical birth-control pill. The Nov. 10 warning followed an analysis by the FDA and the manufacturer of Ortho Evra, Ortho McNeil Pharmaceuticals, that compared blood levels of estrogen and progestin over three weeks in women using the patch with those on a typical birth-control pill.
In general, increased estrogen exposure from oral contraceptives is associated with an increased risk of rare but serious side effects, including blood clots in the leg veins, which can break off and become lodged in the lungs. It's not yet known whether the greater exposure to estrogen from Ortho Evra translates into a higher risk of clots. Despite news reports over the past year alleging that women on the patch suffer serious adverse events more often than women taking standard birth-control pills, studies thus far have not established any increased risk.
Approved by the FDA in 2002, the patch is worn on the buttocks, abdomen, upper torso, or arm and changed just once a week. It's the first and only birth-control patch on the market.
What you can do
- The birth-control pill, with its longer safety record, may be a more prudent choice than the patch.
- Women who choose the patch because they have trouble remembering to take the pill every day should work with their doctors to weigh the possible risks of the extra estrogen from the patch against the risk of an unwanted pregnancy from failing to take the pill consistently.
- Women who have a greater-than-average risk of blood clots—including those with a history of blood clots or cardiovascular disease and those who smoke and are older than 35—shouldn't use any estrogen-containing contraceptive at all. Note that while the patch and pill are comparable in their ability to prevent pregnancy if used correctly, Ortho Evra's effectiveness, unlike the pill's, declines in women weighing more than 200 pounds.
This site is for your information only. For medical advice, consult a health professional.
