Ortho Evra®, manufactured by Ortho McNeil, a subsidiary of Johnson & Johnson, is a form of birth control delivered via a transdermal patch - a patch placed on the skin. The contraceptive was approved by the FDA on November 20, 2001. Since it went on the market in April 2002, Ortho Evra® has been prescribed to over four million women. The product contains 0.75 mg ethinylestradiol and 6.0 mg norelgestromin hormones in a single patch. The gradual release of hormones over the course of each week acts much like contraceptive pills do. Most commonly, ovulation is inhibited entirely, preventing pregnancy.
FDA Warning & Label Update
The FDA issued a warning in 2005 regarding Ortho Evra use that pointed out the dangers of an increased exposure to estrogen and a higher risk of blood clots when using the product. The patch's label was subsequently updated. The problem is, the original label understated that the patch's risk, describing them as similar to the risks of the pill. We now know that Ortho Evra side effects are far more serious than scientists originally thought.
Ortho Evra & Blood Clots
Blood clots typically form in the legs and become very dangerous when they move to the heart, brain or lungs. Deep vein thrombosis and pulmonary embolism can lead to strokes, heart attacks, hemorrhaging, and even death. While oral contraceptives (the birth control pill) may also cause clotting due to the estrogen they contain, adverse event reports continue to show that the transdermal method of hormone delivery increases the risk of clotting by increasing a patient's exposure to estrogen to about 60% as compared to women taking an oral contraceptive containing 35 micrograms of estrogen. Ortho Evra® releases the hormones norelgestromin (a progestin hormone) and ethinyl estradiol (an estrogen hormone) directly into the bloodstream. Treatment for blood clots can include long term anticoagulant medications.
Ortho Evra in the News
If you or a loved one has suffered from blood clots or another injury from the use of the birth control patch, you need to speak to a qualified attorney. The Morelli Ratner law firm is experienced in dangerous drug litigation of all types, with years of knowledge regarding pharmaceutical industry recalls. For more information, contact their Ortho Evra lawyers today.