Ortho Evra birth control patch blood clot warning strengthened by FDA

By Harvey Kirk
Posted January 19, 2008

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Late Friday afternoon, the FDA and Johnson & Johnson announced that the warning label for Ortho Evra will be strengthened to include new information from a study which confirms users of the birth control patch face an increased risk of serious and potentially fatal blood clots, known as venous thromboembolism (VTE). The Ortho Evra blood clot risk is already on the label, but the stronger warning will remove conflicting information about whether the risk is greater than that associated with the birth control pill.

>>INFORMATION: Ortho Evra birth control patch blood clot risk

The Ortho Evra patch is a newer form of birth control which was approved by the FDA in 2002. It is the only form of birth control which delivers the active ingredients through a patch which is placed on the skin. However, side effects of the birth control patch could result in increased amounts of estrogen being delivered into the blood stream, which increases the risk of blood clots, deep vein thrombosis, pulmonary embolism, heart attacks, strokes and death.

Johnson & Johnson currently faces lawsuits from over 2,400 users of the birth control patch who have been injured by the drug, and Ortho Evra settlements have already been made by the drug manufacturer for some women who pursued claims. Although the manufacturer has been aware of the blood clot risk for some time, the Ortho Evra warning label has not fully disclosed the true extent of the risk.

In 2005, information was added to the warning label that indicated users of the Ortho Evra patch were exposed to 60% more estrogen than women taking birth control pills containing 35 mg of estrogen. In September 2006, information was added about one study which found that Ortho Evra side effects potentially double the blood clot risk, but conflicting information was also included about another study which indicated that users of the patch and the pill could face equal risks.

Based on the results of a new study conducted by the Boston Collaborative Drug Surveillance Program, the warning label will now be strengthened to remove conflicting information. The study, which was sponsored by Johnson & Johnson, involved women ages 15 to 44. When compared with women using a birth control pill, users of the Ortho Evra patch were found to have a higher risk for a venous thromboembolism (VTE). The serious blood clot could develop in the veins and lead to potentially fatal injuries if it travels to the lungs and causes a pulmonary embolism.

Although the new warning is stronger, it is not a “black box” warning, which would be the strongest warning that can be placed on a prescription drug. Many experts and consumer advocates have indicated the drug should be removed from the market, since there are no unique advantages to the birth control patch over the pill and other available contraceptives. However, there is no indication that the FDA is considering an Ortho Evra recall at this time.

ORTHO EVRA BLOOD CLOT LAWSUITS

The Ortho Evra lawyers at Saiontz & Kirk, P.A. represent women who have suffered a blood clot resulting in a heart attack, stroke, deep vein thrombosis, pulmonary embolism or death. Birth control patch lawsuits are being reviewed throughout the United States to pursue compensation for women who have been impacted by Ortho Evra side effects.

If you, a friend or family member have suffered an injury after using the Ortho Evra birth control patch, request a free claim evaluation.