FDA Warns Ortho Evra Contraceptive
Patch Users
Ortho Evra
Contraceptive Patch News Alerts and Lawyer Updates
On November 11, 2005, the
Food and Drug Administration (FDA) announced that the Ortho Evra
contraceptive patch exposes the millions of women who use them to
levels of estrogen far higher than most daily birth control pills,
putting them at higher risk for blood clots. The FDA also approved
updated labeling for the Ortho Evra contraceptive patch to warn
healthcare providers and patients about the increased risk.
The patch exposes women to 60 percent
more estrogen than daily birth control pills, which contain 35
micrograms. Ortho Evra, made by Ortho McNeil, is the first and only
skin patch approved for birth control, and more than 4 million women
have used the patch since it came on the market three years ago. The
patch releases ethinyl estradiol, and estrogen hormone, and
norelgestromin, a progestin hormone, through the skin into the
bloodstream. It only needs to be changed once a week.
The Associated Press in July reported
that, according to FDA records it obtained through a Freedom of
Information Act, women using Ortho Evra in 2004 were three times as
likely as women using birth control pills to die or develop nonfatal
blood clots. The Associated Press learned that of the 23 cases in
which death was the outcome, doctors reviewing the cases found 17
that appeared to be blood-clot-related, including 12 in 2004.
Since the FDA estimates that it
receives reports of only between 1 percent and 10 percent of the
serious adverse drug reactions that actually occur, the death rate
for Ortho Evra may be significantly higher.
The Ortho-Evra patch, which is
available by prescription only, has not yet been pulled off the
market. The drug maker says it is launching its own study with input
from the FDA to assess the dangers of using the patch. Women who may
be using Ortho Evra should contact their physician if any of the
following warning signals develop:
- Sharp chest pain, coughing of
blood, or sudden shortness of breath (indicating a possible clot
in the lung)
- Pain in the calf (indicating a
possible clot in the leg)
- Crushing chest pain or tightness
in the chest (indicating a possible heart attack)
- Sudden severe headache or
vomiting, dizziness or fainting, disturbances of vision or
speech, weakness, or numbness in an arm or leg (indicating a
possible stroke)
- Sudden partial or complete loss
of vision (indicating a possible clot in the eye)
- Breast lumps (indicating
possible breast cancer or fibrocystic disease of the breast; ask
your doctor or health care professional to show you how to
examine your breasts)
- Severe pain or tenderness in the
stomach area (indicating a possibly ruptured liver tumor)
- Severe problems with sleeping,
weakness, lack of energy, fatigue, or change in mood (possibly
indicating severe depression)
- Jaundice or a yellowing of the
skin or eyeballs accompanied frequently by fever, fatigue, loss
of appetite, dark colored urine, or light colored bowel
movements (indicating possible liver problems)
ORTHO EVRA CONTRACEPTIVE PATCH LAWYERS / ATTORNEYS
If you or a loved one have suffered from the dangerous side effects
of the Ortho Evra contraceptive patch, you should consider receiving
a free legal evaluation from an experienced injury lawyer. For a
free evaluation of your situation please complete the following form
and a Ortho Evra contraceptive patch attorney will contact you promptly -- free of charge.
ORTHO EVRA CONTRACEPTIVE PATCH NEWS
& LAWYER UPDATES
FDA Notifies Ortho Evra Contraceptive Users
FDA -MedWatch - September
20, 2006
...Ortho-McNeil and FDA notified healthcare professionals and
patients about revisions to the prescribing information to inform
them of the results of two separate epidemiology studies that
evaluated the risk of developing a serious blood clot in women using
Ortho Evra compared to women using a different oral contraceptive.
FDA
Warns Ortho Evra Contraceptive Patch Users
CBS News - November 11, 2005
... The Food and Drug Administration has issued a
public warning on Ortho Evra Contraceptive Patch blood clot risks.
FDA says patch has blood clot risk
CNN - November 11, 2005
...
The Food and Drug Administration on Thursday warned millions of women
who use the Ortho Evra contraceptive patch that they are being exposed to
about 60 percent more estrogen than with a typical birth control pill, which
could put them at higher risk for blood clots.
FDA Issues Warning for Contraceptive Patch
Los Angeles
Times -
November 11,
2005
... Users of the Ortho Evra contraceptive patch are exposed to more estrogen
than from birth control pills and therefore are at higher risk of
blood clots and other side effects, the Food and Drug Administration
has warned. The federal agency Thursday approved updated
labeling containing the warning. Patch-maker Ortho McNeil posted the
warning on the website operated by its parent company, Johnson &
Johnson.
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