By: Maayan S. Heller for Uterus1Since the Ortho Evra contraceptive patch was introduced to the market, many women have praised the breakthrough in convenience that allows them to forgo their daily pill. In the past few months, however, other women have been placing frantic calls to their doctors. In November, the FDA announced new labeling for the patch – the first and only one of its kind – warning that it exposes women to higher levels of estrogen than other birth controls, which may increase the risk for blood clots.
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The risk of blood clotting, in perspective:
For a normal, healthy, young woman, not on the patch or pill – the risk of clotting events is 4 or 5 out of 100,000 women
For a normal, healthy young woman on the pill - the risk increases 3-4 fold, to 15 out of 100,000 women
For a pregnant woman, the risk increases 12-fold, to 60 out of 100,000 women
Women who should NOT be on the patch include the following:
Anyone with strong personal or family history of clotting
Anyone who smokes and who is over 35 years old (this increases the risk of heart attack)
Anyone with a known cancer that’s estrogen-dependent (like breast or uterine cancer)
Anyone with gallbladder disease
Anyone with classic migraine headaches
Women over 198 lbs.(90 Kg)
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A lawsuit filed last summer by 10 women in New Jersey against the companies that manufacture Ortho Evra alleged the patch is unreasonably dangerous and caused them to suffer strokes and blood clots. According to the FDA’s Web site, “the addition of this new warning [to the Ortho Evra label] is a result of … analysis directly comparing the levels for estrogen and progestin hormones in users of Ortho Evra with those in a typical birth control pill.”
Though the new label raises questions, it hasn’t been shown whether women using it have a higher risk of serious side effects than those taking typical birth control pills. Some doctors guess the lawsuit pushed the FDA to amend the patch’s label, but emphasize that the risk itself didn’t change, just explanations on the packaging.
Since its introduction in 2002, about four million women have used Ortho Evra, a weekly prescription patch that releases estrogen and progestin hormones into the bloodstream through the skin. Because it’s applied only once a week, the chance a woman might miss one or more doses, which often occurs with the pill, goes down.
“If I have a patient who knows she’ll have trouble taking a daily pill, the patch is a good option,” says Maura Quinlan, MD, assistant professor of OB/GYN at the University of Chicago.
The trade-off, as the FDA notes, is an increase in the amount of estrogen absorbed. The patch may expose women to approximately 60% more estrogen than the typical 35 microgram pill. However, this higher percentage is somewhat deceptive. Because the total amount of estrogen delivered is higher, the maximal (peak) blood level of estrogen is about 25% lower with Ortho Evra than with most birth control pills.
“The difference with the patch is, you put it on and within the first 24-48 hours the estrogen levels reach a plateau, and they’ll stay there – at a steady level – for the week. With the pill, it’s a level that rises and falls day by day,” explains Radha Reddy, MD, an OB/GYN in Cincinnati, Ohio.
No one knows the consequences of increased estrogen levels in this form since there is neither long-term experience with the patch nor any conclusive scientific study.
According to doctors, blood clots are a risk with any estrogen increase, including using the patch and pill, and with pregnancy.
“In terms of the dangers of blood clots, it’s actually much riskier to be pregnant than to take any form of contraception,” says Dr. Quinlan, “so in the balance of risks, the patch is safer than unwanted pregnancy.”
Furthermore, Erika Schwartz, MD, a physician, author and women’s health advocate in New York City, stresses that any estrogen-containing birth control raises the possibility of clotting, among other risks. “Synthetic estrogens like the ones in birth control pills, patches, rings, etc. are substances that override the woman's hormone production system and open the door for potentially lethal problems,” she says, and suggests birth control alternatives without hormones, like diaphragms or condoms.
Even the FDA emphasizes that “it is not known whether women using Ortho Evra are at a greater risk.” Its Web site states that studies are currently being conducted comparing the risks with Ortho Evra to those with typical birth control pills.
In the meantime, Dr. Reddy has had many patients call her, worried and panicked, after learning about the labeling. She says the problem is “that the whole story isn’t – and wasn’t – available.” She still prescribes the patch, and emphasizes that it’s crucial “to put the risk of [clotting] in perspective.”
“The truth is, nobody’s 100 percent safe,” she says. “There’s no absolute with birth control. Women need to know their bodies, their abilities to manage their care, and their personal and family medical histories and be open to discussing these and the risks of birth control with their doctors.”
