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Ortho Evra Birth Control Patch Linked to Heart Attack's and Stroke
Upwards of 5 million women have used the Ortho Evra Birth Control Patch since it was approved by the FDA in November 2001. Touted as a safe alternative to pills, the Ortho Evra patch has recently been linked to reports showing increased risk of serious blood clots in women who are using the patch.
Worn on the upper arm, upper torso, stomach or buttocks, the patch is generally considered more convenient than oral contraceptives. So far, reports have shown that as many as 17 women who were using the Ortho Evra patch have died as a result of blood clots. While a link between these deaths and the patch has yet to be substantiated, there is sufficient evidence to support one. Amy Allina of the Washington-based National Women's Health Collective has suggested that the FDA begin a large-scale study to examine the effects of the Ortho Evra patch. According to the AP, such a study was recommended by an FDA medical reviewer at the time the patch was approved, but the FDA chose not to implement one.
FDA notified healthcare professionals and patients of revisions to the label for Ortho Evra, a skin patch approved for birth control, that includes a bolded warning about higher exposure to estrogen for women using the weekly patch compared to taking a daily birth control pill containing 35 micrograms of estrogen. A woman on Ortho Evra may be exposed to approximately 60% more estrogen than if she were taking a typical 35 microgram estrogen birth control pill. Estrogen use is linked to blood clots in the legs and lungs and other clotting problems such as strokes and heart attacks. It is not known if women using Ortho Evra have a higher risk of serious side effects than women taking the typical 35 microgram estrogen pills.
FDA is announcing a revision to the label for the drug Ortho Evra, the only skin patch approved for birth control. This change includes a new bolded warning about higher exposure to estrogen for women using the weekly patch compared to taking a daily birth control pill containing 35 micrograms of estrogen, a commonly prescribed dose. Higher levels of estrogen may put some women at increased risk for getting blood clots. When thinking about prescribing or using Ortho Evra, healthcare professionals and women need to balance the increased exposure to estrogen against the chance of pregnancy if a birth control pill is not taken daily.
Why is the FDA making this announcement?
A woman on Ortho Evra may be exposed to approximately 60% more estrogen than if she were taking a typical 35 microgram estrogen birth control pill. There are also high dose estrogen pills on the market, such as the 50 microgram birth control pills, and some women need these. Estrogen use is linked to blood clots in the legs and lungs and other clotting problems such as strokes and heart attacks. It is not known if women using Ortho Evra have a higher risk of serious side effects than women taking the typical 35 microgram estrogen pills.
How does the increase in exposure of estrogen affect me when taking Ortho Evra?
In general, a woman may be at higher risk for getting side effects if she takes higher doses of estrogen. However, it is not known if a woman using the Ortho Evra patch is at higher risk for serious side effects than if she is using a typical birth control pill. Women should discuss with their health care professional whether the Ortho Evra patch is a good method of contraception for them.
Can a woman decrease the amount of estrogen from the Ortho Evra patch by cutting the patch and applying only a part of the patch?
No. The patch should not be cut. If cut or altered, Ortho Evra will not protect against pregnancy.
If a woman wants to change from the Ortho Evra patch to a birth control pill, what should she do?
Talk to her health care professional. The health care professional will help her make this change.
While women’s health specialists have long been aware of the risk of blood clots associated with birth control pills, the AP reports that such risks may be three times greater with the patch. If you or someone you know has suffered adverse health effects as a result of using the Ortho Evra patch, you should contact an attorney. For a free case evaluation, please fill out the form below:
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