Breaking News - FDA Updates Labeling for Ortho Evra® Contraceptive Patch
On November 11th, 2005, The Food and Drug Administration 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® is a birth control patch that has been prescribed to more than 5 million women. This new form of birth control was aggressively marketed to consumers and doctors as a safe and convenient alternative to oral birth control pills. Ortho Evra® has become the most popular prescribed form of birth control in the United States. Manufactured by Ortho-McNeil Pharmaceutical, Inc., a division of Johnson & Johnson, the patch is currently under scrutiny for possible dangers associated with use. Some serious side-effects including serious injury and death have been linked to the use of this patch. Due to these serious side effects linked to Ortho Evra®, the patch is now the target of lawsuits filed on behalf of victims who have suffered injury or death after using the patch. If you or a loved one has been using the Ortho Evra® patch, and feel the drug has caused injury or death, the lawyers at Balkin & Eisbrouch, LLC may be able to help you. Please email us for more information.
Ortho Evra® Dangers
Since the patch was made available for consumer use, it has become associated with a significantly higher rate of incidents of stroke,
transient ischemic attack ("TIA"), emboli, blood clots, heart attacks, coma, and death, as well as other severe and permanent health consequences than other forms of birth control. Though the makers of Ortho Evra® did warn that these injuries could occur while using the patch, their claim was that the occurrence of these injuries was not only low, but was at the same rate as birth control pills. However, although the hormones used in both forms of birth control are similar, the method of administration is not. The hormones in the patch are delivered directly into the bloodstream, through the skin, by a time-release mechanism, bypassing the liver, which changes the relative activity of the various clotting factors that can ultimately set the stage for clot formation. Further, even trace amounts of additional estrogen via a time-release rather than the regimented and well-set amount delivered by daily oral doses through birth control pills can cause the tragic injuries that we are seeing. There have been over 9,000 reports to the FDA of adverse reactions over a 17-month period. Further, Otho-McNeil relied primarily on safety and risk information derived from studies of birth control pills taken orally, not through a transdermal patch. There have also been 17 deaths of young women that may be related to the use of Ortho Evra®.
We Can Help!
Balkin & Eisbrouch, LLC is a national law firm covering all fifty states as well as Canada, Puerto Rico and all American possessions. No matter where you live, we will have an experienced personal injury attorney represent you.
If you or someone you love has been injured or died while using the Othro Evra Patch, you may be entitled to a large compensatory award. Call us now at 1-800-RESULTS (1-800-737-8587). Or Email us for more information.
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