Monday, August 13, 2007

New Contraceptive Patch Leads to Concerns About Health

The Ortho Evra Patch released by Ortho McNeil has recently come under fire for the patch’s contribution to serious thrombotic problems such as heart attack and stroke.

After its approval in November 2001, the Ortho Evra Birth Control Patch revolutionized birth control by allowing women to wear a patch directly on their body giving it the nickname the “Birth Control Band-Aid.” Following its release to the public in 2002 over 5 million women have tried the Ortho Evra contraceptive.

Recently, however, the Ortho Evra Patch has been linked to an increased risk of a number of serious thrombotic problems. These problems might include heart attack, stroke, blood clots, myocardial infarction, pulmonary embolism and deep vein thrombosis.

Those problems have been shown to be caused by the constant level of estrogen and progestin absorbed by the body while the patch is in use. Oral contraceptives, as compared with the Ortho Evra Patch, give users 35 micrograms (mcg) of estrogen in a daily dose as opposed to the patch that provides 20 mcg continuously for a week.

A British study completed in 1969 found that the body could not receive estrogen in excess of 50 mcg without the risk of inflicting the user with serious blood clots. All companies selling estrogen with more than 50 mcg had taken their products off the market by 1988.

The problem with the Ortho Evra Patch is that, although it only is a 20 mcg dosage of estrogen, it provides it for a prolonged period of time. The FDA issued a new warning in November of last year, asserting that the Ortho Evra Patch exposes users to 60% more estrogen than those on the oral contraceptive.

Essentially, the patch actually floods the users system with a 56 mcg dosage of estrogen over a longer period of time

There have also been new studies that have been released indicating that progestin, another active ingredient in the Ortho Evra Patch, also poses dangers to health. An anti-throbotic, prostegin inhibits the user’s blood from forming clots. This is the opposite of estrogen, a pro-thrombotic, which causes blood to clot. It was thought that each would cancel the other out. What everyone failed to see was that the prostegin, which was a 3rd generation version of the drug, indicating that the drug actually allows for the creation of more blood clots. This combined with the increased dosage of estrogen puts women at serious risk for many clotting-related issues such as heart attacks and strokes.

It was discovered that the Ortho Evra Patch fails to warn women adequately of the risks imposed on them by the levels estrogen and progestin exposure.

Currently, there are many attorneys that are working on a class action lawsuit against Ortho McNeil, maker of Ortho Evra. You may qualify to join this lawsuit if you:

Have been prescribed the Ortho Evra Patch

Have taken oral contraceptives for an extended period of time prior to using the Ortho Evra Patch without incident.

Suffered from a serious thrombotic event like heart attack, stroke, pulmonary embolism, blood clot, etc.

Were forced to stay in a hospital for an extended period of time as a result of the thrombotic incident

Were forced to undergo surgery as a result of the thrombotic incident Have to undergo coagulant therapy for at least 6 months.

Also, if you are a smoker and have had a thrombotic event after using the Ortho Evra Patch, you may still qualify to file a lawsuit. Although there is a warning against smoking while using the Ortho Evra Patch, it does not specify the severity of the consequences, or mention the risks associated with smoking while using the Ortho Evra Patch.
Sara Goldstein

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