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Ortho Evra & Heart Attacks, Strokes, Blood Clots
Ortho Evra Lawyer, Lawsuit, Recall Information

Ortho McNeil Issues Warnings About Orth Evra Birth Control Patch

The makers of Ortho Evra, a popular birth control patch, have issued a series of warnings regarding health risks associated with the patch.

Possible side effects focus primarily on an increased risk of blood clots which can lead to a heart attack or stroke.

Ortho McNeil has issued the following warning regarding Ortho Evra:

"Important Safety Information: Most side effects of the Patch are not serious and those that are, occur infrequently. Serious risks, which can be life threatening, include blood clots, stroke and heart attacks and are increased if you smoke cigarettes. Cigarette smoking increases the risk of serious cardiovascular side effects, especially if you are over 35. Women who use the Patch are strongly advised not to smoke. Some women should not use the Patch, including women who have blood clots, certain cancers, a history of heart attack or stroke, as well as those who are or may be pregnant.

Hormones from patches applied to the skin get into the blood stream and are removed from the body differently than hormones from birth control pills taken by mouth. You will be exposed to about 60% more estrogen if you use ORTHO EVRA than if you use a typical birth control pill containing 35 micrograms of estrogen. In general, increased estrogen exposure may increase the risk of side effects. However, it is not known if there are differences in the risk of serious side effects based on the differences between ORTHO EVRA and a birth control pill containing 35 micrograms of estrogen.

You should discuss with your healthcare professional whether ORTHO EVRA is a good method of contraception for you. The Patch does not protect against HIV or sexually transmitted diseases."

Have you been injured as a result of Ortho Evra? We are a team of lawyers with a long track record of taking on large pharmaceutical companies like Ortho McNeil. We only handle individual claims with serious damages. Serious claims require individual time and attention. If you believe you may have a claim, contact us today toll free at (800) 253-5537 for an immediate, free phone consultation.

Free Ortho Evra Contraceptive Patch Case Evaluation

It may be that you are entitled to compensation due to injuries suffered from the contraceptive patch Ortho Evra. If you suffered a serious side effect including complications from a blood clot such as a heart attack, stroke or other serious medical condition, please contact us for a free case evaluation.

Our lawyers will provide you with a free case evaluation. Simply click on the following link to complete a short form and one of our attorneys will contact you today. We evaluate cases nationwide. Click here to complete a short form

News

FDA Updates Labeling for Ortho Evra Contraceptive Patch
November 10, 2005

The Food and Drug Administration today approved updated labeling for the Ortho Evra contraceptive patch to warn healthcare providers and patients that this product exposes women to higher levels of estrogen than most birth control pills. Ortho Evra was the first skin patch approved for birth control.

It is a weekly prescription patch that releases ethinyl estradiol (an estrogen hormone) and norelgestromin (a progestin hormone) through the skin into the blood stream. FDA advises women to talk to their doctor or healthcare provider about whether the patch is the right method of birth control for them.

Furthermore, women taking or considering using this product should work with their health care providers to balance the potential risks related to increased estrogen exposure against the risk of pregnancy if they do not follow the daily regimen associated with typical birth control pills. Because Ortho Evra is a patch that is changed once a week, it decreases the chance associated with typical birth control pills that a woman might miss one or more daily doses.

The addition of this new warning is a result of FDA's and the manufacturer's analysis directly comparing the levels for estrogen and progestin hormones in users of Ortho Evra with those in a typical birth control pill. In general, increased estrogen exposure may increase the risk of blood clots. However, it is not known whether women using Ortho Evra are at a greater risk of experiencing these serious adverse events.

The new bolded warning specifically states that women who use Ortho Evra are exposed to about 60 percent more total estrogen in their blood than if they were taking a typical birth control pill containing 35 micrograms of estrogen. However, the maximal blood level of estrogen (peak blood levels) is about 25% lower with Ortho Evra than with typical birth control pills. While the estrogen level with the patch remains constant for one week until the patch is removed, the peak blood levels with a daily birth control pill rapidly declines to levels that are lower than on the Orthro Evra.

FDA is continuing to monitor safety reports for the Ortho Evra patch. The manufacturer, Ortho McNeil Pharmaceuticals is conducting additional studies to compare the risk of developing serious blood clots in women using Ortho Evra to the risk in women using typical birth control pills that contain 35 micrograms of estrogen.

The new labeling information is available along with additional information for healthcare providers and consumers online at: www.fda.gov/cder/drug/infopage/orthoevra/default.htm.

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