FDA approves Ortho Evra’s new warning label

fda logo 100x100 FDA approves Ortho Evras new warning labelJohnson & Johnson, the makers of the Ortho Evra (norelgestromin/ethinyl estradiol) birth control patch, has updated the drug’s warning label to include new data on the odds ratio estimates of venous thromboembolism risk in women on Ortho Evra compared to users of oral contraceptives. The new label was approved by the Food and Drug Administration (FDA).

Venous thromboembolism is a blockage of an artery in the lungs by fat, air, a blood clot or tumor cells. Oral contraceptives, such as Yaz, Yasmin and the generic Ocella, put women at risk for blood clots. The patch is no exception. In the past few years, Johnson & Johnson settled several lawsuits filed against it from women who alleged that the contraceptive patch caused blood clots and other serious side effects due to heightened estrogen levels.

The transdermal patch includes the following warning: “Hormones from ORTHO EVRA® get into the bloodstream and are processed by the body differently than hormones from birth control pills. You will be exposed to about 60% more estrogen if you use ORTHO EVRA® than if you use a typical birth control pill containing 35 micrograms of estrogen. In general, increased estrogen may increase the risk of side effects. The risk of venous thromboembolic events (blood clots in the legs and/or the lungs) may be increased with ORTHO EVRA® use compared with use of birth control pills. Studies examined the risk of these serious blood clots in women who used either ORTHO EVRA® or birth control pills containing one of two progestins (levonorgestrel or norgestimate) and 30–35 micrograms of estrogen. Results of these studies ranged from an approximate doubling of risk of serious blood clots to no increase in risk in women using ORTHO EVRA® compared to women using birth control pills.”

The patch’s new label lowers the system’s odds ratio for venous thromboembolism risk from 2.5 (1.1-5.5) to 2.2 (1.2-4.0). This change additional 24 months of data from the i3 Ingenix Study and data from a new post-marketing study conducted by the Boston Collaborative Drug Surveillance Program (BCDSP).