ORTHO EVRA

Ortho Evra Birth Control Patch (norelgestromin/ethinyl estradiol)

There have been three different studies done on Ortho Evra:

The first study was conducted by the Boston Collaborative Drug Surveillance Program (BCDSP). This study found that the risk of non-fatal VTE events associated with the use of the Ortho Evra contraceptive patch is similar to the risk associated with the use of oral contraceptive pills (OCs) containing 35 micrograms of ethinyl estradiol and the progestin norgestimate. Analysis of 17 months of data on new cases not included in the original report showed a similar finding.

The second study, which included review of patients� charts, was conducted by another group of investigators (i3 Ingenix). Results of this study showed an approximately two-fold increase in the risk of medically-verified VTE events in users of Ortho Evra compared to users of OCs containing 35 micrograms of estrogen and the progestin norgestimate.

The third study, also conducted by BCDSP, compared the risk of non-fatal VTE events among users of Ortho Evra to the risk among users of OCs containing 30 micrograms of ethinyl estradiol and the progestin levonorgestrel. The results showed an approximately two-fold increase in the risk of VTE among the Ortho Evra users.

These epidemiology studies were conducted to evaluate the risk of developing a serious blood clot in women using Ortho Evra compared to women using different, commonly prescribed, oral contraceptive pills containing from 30-35 micrograms of the estrogen ethinyl estradiol and one of two progestins (norgestimate or levonorgestrel). Concern about this risk arose based on reports to FDA and to Johnson and Johnson of serious blood clots, which suggested that use of Ortho Evra might pose a greater risk of VTE, at least in some women, compared to use of oral contraceptives.

Even though the results of the three studies are conflicting, the results from two of the studies support FDA�s concerns regarding the potential for use of Ortho Evra to increase the risk of blood clots in some women. The label continues to recommend that women with concerns or risk factors for thromboembolic events talk with their healthcare provider about using Ortho Evra versus other contraceptive options.

FDA Updates Labeling for Ortho Evra Contraceptive Patch

Ortho Evra has updated labeling for the Ortho Evra contraceptive patch to warn healthcare providers and patients that this product exposes women to higher levels of estrogen than most birth control pills. Ortho Evra was the first skin patch approved for birth control. It is a weekly prescription patch that releases ethinyl estradiol (an estrogen hormone) and norelgestromin (a progestin hormone) through the skin into the blood stream. FDA advises women to talk to their doctor or healthcare provider about whether the patch is the right method of birth control for them.

Furthermore, women taking or considering using this product should work with their health care providers to balance the potential risks related to increased estrogen exposure against the risk of pregnancy if they do not follow the daily regimen associated with typical birth control pills. Because Ortho Evra is a patch that is changed once a week, it decreases the chance associated with typical birth control pills that a woman might miss one or more daily doses.

In general, increased estrogen exposure may increase the risk of blood clots. However, it is not known whether women using Ortho Evra are at a greater risk of experiencing these serious adverse events. The new bolded warning specifically states that women who use Ortho Evra are exposed to about 60 percent more total estrogen in their blood than if they were taking a typical birth control pill containing 35 micrograms of estrogen. However, the maximal blood level of estrogen (peak blood levels) is about 25% lower with Ortho Evra than with typical birth control pills. While the estrogen level with the patch remains constant for one week until the patch is removed, the peak blood levels with a daily birth control pill rapidly declines to levels that are lower than on the Orthro Evra.

FDA is continuing to monitor safety reports for the Ortho Evra patch. The manufacturer, Ortho McNeil Pharmaceuticals is conducting additional studies to compare the risk of developing serious blood clots in women using Ortho Evra to the risk in women using typical birth control pills that contain 35 micrograms of estrogen.

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