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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 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.>
Click here
for Ortho Evra resources |
