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*** ORTHO EVRA PATCH INJURIES & ACCIDENTS *** The Fox Law Firm is Reviewing Potential ORTHO EVRA PATCH Claims Have you experienced severe health issues following the use of Ortho Evra Patch? Have your loved ones suffered adversely following the use of the Ortho Evra Patch? If so, you should contact us immediately to protect your legal rights. If you or your loved ones have experienced any of these side effects you may have a claim for legal compensation. Contact The Fox Law Firm for superior legal representation. Ortho Evra is a prescription-based patch that releases a product called ethinyl estradiol (which is an estrogen hormone) and norelgestromin (a progestin hormone) through the skin and into the blood stream of the patient. As a result of the fact that hormones which are released via patch are processed by the body in a different way to hormones from birth control pills, women who have been prescribed the patch could potentially be exposed to approximately 60 percent more estrogen than if they were using typical birth control pills - that contain 35 micrograms of estrogen. Elevated levels of estrogen can increase certain risk-factors that may result in serious and life-threatening side-effects, including blood-clots, or VTE: venous thromboembolism. VTE may result in a potentially fatal pulmonary embolism. In September 2006, the Food and Drug Administration (FDA) revised the labeling for Ortho Evra to advise women of the potential risks posed by VTE. The FDA’s warning was drawn from the findings of two epidemiology studies. One of the studies in question, which was undertaken by i3 Ingenix, revealed that some women who were using the Ortho Evra patch were at a two-fold greater risk of developing VTE. On January 18, 2008, the FDA approved further changes to the Ortho Evra Patch labeling to include the findings of a new epidemiology study that concluded users of the birth control patch were at greater risk of developing serious blood clots than were women using pill-based birth control methods. The January 2008 labeling changes were formulated following a study carried out by the Boston Collaborative Drug Surveillance Program (BCDSP) on behalf of Johnson and Johnson. The patch was studied in women in the age group of 15 to 44. These newer conclusions offered further support to the conclusions of an earlier study that also stated women in this particular age group were at a higher risk of developing VTE. "For women that choose to use contraceptives, it is important that they thoroughly discuss with their health care providers the risks and benefits involved," stated Janet Woodcock, M.D., the FDA's Deputy Commissioner for Scientific and Medical Programs, Chief Medical Officer, and Acting Director of the Center for Drug Evaluation and Research. "This is an example of FDA working in tandem with the drug manufacturer to keep the public informed of new safety data and epidemiological studies that may impact health decisions about the use of FDA approved products,” she added. The FDA strongly recommends that women should discuss with their own health care provider the possible increased risk of VTE with Ortho Evra, which is applied once a week, and balance this risk against the increased chance of pregnancy if they choose not to use the contraceptive. The FDA concludes that Ortho Evra is a safe and effective method of contraception – when it is used according to the labeling, which recommends that women with either concerns or risk factors for serious blood clots talk with their health care provider about using Ortho Evra versus other contraceptive options. The Ortho Evra Contraceptive Transdermal Patch is manufactured by Ortho McNeil Pharmaceuticals, a division of Johnson and Johnson. Additional Information:
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