FOR IMMEDIATE RELEASE
Nov. 10, 2005
FDA Updates Labeling for potential risks ORTHO EVRA Birth Control Patch
The Food and Drug Administration today approved updated labeling on black box warning of the ORTHO
EVRA birth control 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. Because ORTHO EVRA is a birth control 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 the 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.
The new black box bold 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.
More estrogen equals more blood clot risks.
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
In other words not much is being done to alert the public to the
dangers of the birth control patch blood clots that lead to death. Millions of
women are being exposed to this unknown danger. The life threatening blood clots caused by the estrogen patch are described in safety reports for ORTHO EVRA. The new ORTHO EVRA patch black box warning can help you learn about the potential risks that ORTHO EVRA presents. Estrogen blood clots are among the unique dangers of the birth control patch.
Have you or a loved one been unknowingly exposed to the birth control patch
dangers? Are you eligible for an ORTHO EVRA lawsuit?
Fill out the below form to see if you qualify for an ORTHO EVRA lawsuit. Ask
our experienced lawyers to review your potential lawsuit. No obligation. Donít
The statistics speak volumes about who is responsible.
The FDA has logged 9,116 reports of adverse reactions to the ORTHO EVRA birth
control patch in a 17-month period, whereas Ortho Tri-Cyclen, a birth control
pill, only generated 1,237 adverse reports in a six year period.
During a 12-month period, 44 serious injuries or deaths have been associated
with ORTHO EVRA birth control patch, whereas only 17 such reports were linked to
the birth control pill during a similar time period.
Coincidentally in October 2005, Bayer HealthCare and Ortho-McNeil
Pharmaceutical, Inc. announced that they have concluded an agreement to jointly
develop and market a new drug for the prevention and treatment of thrombosis.
(Thrombosis is the technical term for blood clots.) The drug called BAY 59-7939
is currently undergoing Phase II clinical trials. Phase III clinical trials will
assess its effectiveness in the prevention of venous thromboembolism (VTE) and
will be initiated in the next weeks.
With 9.9 million prescriptions the numbers of women with extreme complications
leading death are just starting to receive media exposure. In July 2005, a
young, healthy married mother of two children experienced shortness of breath
and died the next day. Symptoms may include shortness of breath, difficulty
breathing, anxiety, chest pain, fainting, and convulsions.
On November 10, 2005, Ortho McNeil, in conjunction with the FDA, issued a
warning about the increased risks of blood clots associated with ORTHO EVRA.
In the new warning, Ortho McNeil admitted for the first time that women who use
the patch will be exposed to up to 60% more estrogen than they would be exposed
to if they were taking birth control pills. The patch is only intended to
deliver 20 micrograms of estrogen. Throughout the medical community, it is a
well-known fact that increased exposure to estrogen greatly increases the risk
of blood clots, which can cause further serious injury or death.
It is alleged that Ortho-McNeil was aware of the increased medical risks
associated with ORTHO EVRA birth control patch before the drug was approved and
when approved -- the company failed to adequately warn patients about these
The deep-pocketed manufacturers of ORTHO EVRA are responsible for misleading
women about their birth control options. Have you or a family member experienced
a life-threatening problem with the birth control? Are you
eligible for an ORTHO EVRA lawsuit?
Fill out the below form to see if you qualify for an ORTHO EVRA lawsuit. Ask our
experienced lawyers to review your potential lawsuit. No obligation. Donít