Ortho Evra Attorneys
The Food and Drug Administration approved
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. The Associated Press has reported that in 2004, approximately 12 women died from complications linked to the birth control patch Ortho Evra. These complications tended to involve blood clots and other thromboembolic events, which occurred twice as often in users on the patch than in users taking the pill. 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.
The addition of this new warning is a result of FDA's and the manufacturer's
analysis directly comparing the levels for estrogen and progestin hormones
in users of Ortho Evra with those in a typical birth control pill. 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 estrogen than if they were taking
a typical birth control pill containing 35 micrograms of estrogen. However,
the maximum amount of estrogen to which women are exposed is about 25%
lower with Ortho Evra than they are with typical birth control pills.
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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