Have you or a loved one suffered from Ortho Evra side effects?

The Ortho Evra® transdermal contraceptive patch, manufactured by Ortho McNeil, a subsidiary of Johnson & Johnson, has been linked with blood clots and deaths. Deep vein thrombosis (DVT) and pulmonary embolism (PE) can lead to strokes, heart attacks, hemorrhaging, and death. Blood clots typically form in the legs and become extremely dangerous when they move to the heart, brain or lungs. Oral contraceptives may also cause blood coagulation due to the estrogen they contain, but reports are now showing that the risk is much higher with the patch method of hormone delivery.

The Ortho Evra® patch releases the hormones norelgestromin (a progestin hormone) and ethinyl estradiol (an estrogen hormone) directly into the bloodstream. It was approved by the FDA on November 20, 2001 and went on the market in April 2002. Since its approval, Ortho Evra® has been heavily marketed to women and prescribing physicians.

Reports are now surfacing about Ortho Evra’s® high incidence of potentially fatal blood clots. Recent analysis of the Ortho Evra® patch data by the Associated Press and other sources revealed that in 2004, when there were 800,000 women using the Ortho Evra® patch, the risk of developing a major blood clot was three times that of oral contraceptive pills. From April 2002 through September 2003, the FDA received 9,116 reports of adverse reactions from the Ortho Evra® patch. For a six year period for Ortho Tri-Cyclen®, the most popular oral birth control pill, the FDA only received 1,237 adverse event reports. Furthermore, Ortho Tri-Cyclen® was used by six times as many women during that time, making the patch’s adverse event incidence rate even more striking. From May 2002 until May 2003, the FDA received 44 reports of serious clot-related injuries or deaths related to Ortho Evra®, compared to only 17 similar reports about Ortho Tri-Cyclen® over the same time period, and with the pill being used by approximately six times as many women.

Gersowitz Libo & Korek, P.C.

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