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Drug manufacturer Johnson & Johnson will update the warning label on the Ortho Evra birth control patch to include information that patch users may face double the risk of developing blood clots compared to oral contraceptives.
According to the company and the Food and Drug Administration, the label changes will reflect the final conflicting results of two Ortho Evra studies.
One study found that the patch carries the same blood clot risk as the pill. While researchers have known for years that estrogen-containing contraceptives heighten the risk of heart attack, stroke, and blood clots, the second study suggests that the Ortho Evra birth control patch exposes users to 60 percent more estrogen than oral contraceptives.
High levels of estrogen has been found to significantly increase the risk of potentially life-threatening side effects including blood clots in the lungs and legs.
The FDA has requested that J&J continue follow-up studies on women using the Ortho Evra patch to monitor reports of cardiovascular events and clotting.
“The label has recommended and continues to recommend that women with concerns or risk factors for thromboembolic disease talk with their health-care provider about using Ortho Evra versus other contraceptive options,” the FDA said.
Suffered Ortho Evra side effects? Please contact us today to consult with a qualified and experienced personal injury attorney who can protect your legal rights and help you recovery your losses.