According to the latest news from the FDA, Ortho and FDA notified healthcare professionals and patients about
changes to the available prescribing information to inform them of the results of two separate epidemiology studies evaluating the risk of developing a serious blood clot in women using Ortho Evra compared to women using a different oral contraceptive.
The first study found that the risk of non-fatal venous thromboembolism (VTE) associated with the use of Ortho
Evra contraceptive patch is similar to the risk associated with the use of oral contraceptive pills containing 35 micrograms of ethinyl estradiol and norgestimate.
In the second study, the increased risk of medically verified VTE events in users of Ortho Evra compared to users of norgestimate-containing oral contraceptives containing 35 micrograms of estrogen was nearly double. The results of the second study support FDA’s concerns regarding the potential for Ortho Evra use to increase the risk of blood clots in some women.
Prescribing information for Ortho Evra continues to recommend that women with concerns or risk factors for thromboemboli disease talk with their healthcare professionals about using Ortho Evra versus other contraceptive options.