FDA updates Ortho Evra contraception patch warnings

On Nov. 10, 2005 the Food and Drug Administration (FDA) approved updated warnings about the use of the Ortho Evra contraception patch and its possible side effects. Specifically, the patch increases average estrogen levels in the bloodstream to levels higher than that of oral contraceptives available on the market. These elevated levels may put women at a higher risk of blot clots, heart problems, and stroke.

Ortho Evra is a transdermal contraceptive patch that releases estrogen into the bloodstream. Like the Pill, this boost of estrogen “tricks” the woman’s body into believing that she is pregnant, and therefore reducing the chance of ovulation. Four million women in the U.S. use this birth control method, preferring to change a patch weekly than to remember taking a daily pill. The FDA approved the Ortho Evra patch for prescription use in April 2002.

Because the estrogen is absorbed through the skin and released directly into the bloodstream, it is a “controlled release” of estrogen throughout the week. With the pill, women experience a spike of estrogen higher than that of the patch, but this quickly falls back down soon after taking it. Further, much of the estrogen – about half – is lost during digestion of the Pill.

But it is this controlled release of Ortho Evra that could lead to problems. Since none of the estrogen is lost on the way to the bloodstream, the patch maintains a higher level of estrogen. In fact, the FDA reports that women can be receiving 60% more estrogen by using the patch rather than the Pill. Too much of this hormone can lead to severe complications like heart attacks, stroke, blood clots, and other medical conditions. It is generally accepted that the higher the level of estrogen in the blood, the higher the risk of severe side effects.

Ortho McNeil, the drug’s manufacturer, has called the basis for this new FDA warning “unscientific.” However, even before it was approved the FDA noticed that the incidence of non-fatal blot clots was three times higher in women using the patch versus those on the Pill. Since 2002, 17 women have died due to side effects caused by the patch, and many more have been injured. Lawsuits in many of those cases are already pending.

If you or a loved one has experienced blot clots, heart attack, stroke, breast cancer, or cancer of the reproductive organs while taking the Ortho Evra transdermal patch, contact a Jim S. Adler & Associates personal injury lawyer for a free case assessment. You may be entitled to compensation for your increased medical bills, lost work, and pain and suffering. But your settlement won’t be just handed to you – call on Jim S. Adler & Associates to make sure you are treated fairly.

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