Ortho Evra Patch Labeling Updates FAQ

September 20, 2006--Information provided by Johnson & Johnson on Feb. 16, 2006 was based on an interim report from one of the two epidemiological studies. The label is now being updated with the available results from the two studies. These two studies were conducted to evaluate the risk of developing a serious blood clot in women using Ortho Evra compared to women using a different, commonly prescribed, oral contraceptive. Concern about this risk was originally based on reports to the FDA about serious blood clots suggested that Ortho Evra may have a greater risk for venous thromboembolism (VTE) for at least some women, compared to oral contraceptives.

Even though the results of the two studies are conflicting, the results of the second epidemiology study support the FDA's concerns regarding the potential for Ortho Evra use to increase the risk of blood clots in some women. The label has recommended and continues to recommend that women with concerns or risk factors for thromboembolic disease talk with their healthcare provider about using Ortho Evra versus other contraceptive options. (FDA)