Vioxx
On August 19, 2005, a Texas jury awarded Carol Ernst $253.4 million dollars
in damages as a result of the death of her husband, Robert, from a heart
attack after he took Vioxx® . The jury found Merck & Co. liable for lost
pay, mental anguish, loss of companionship and punitive damages.
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Vioxx is a COX II inhibitor, which
is a family of non-steroidal anti-inflammatory drugs. This family was
thought to be an advance over existing anti-inflammatory drugs as they have
been proven to cause less stomach irritations and possible resulting
complications such as stomach bleeding and ulceration.
Vioxx was pulled off the shelves worldwide on September 30th after a
clinical study confirmed concerns that it raises the risk of heart attack and
stroke, which can lead to serious and permanent injuries and death. More than 2
million people worldwide are using Vioxx.
Serious complications can begin
approximately 6 months after patients start taking
Vioxx. |
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Previous clinical trials had linked Vioxx to an increase in blood clots and other cardiovascular problems, including
heart attack, chest pain related to heart disease, stroke and sudden death.
Vioxx users were more than three times as likely to experience serious heart
problems than patients using the control drug. One study has linked Vioxx to
27,785 heart attacks and sudden cardiac deaths
Vioxx Side Effects
Recently a report in the
Journal of the American Medical Association linked Vioxx to blood
clots, heart attacks, and strokes.
Other serious side effects
associated with Vioxx usage are:
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Serious stomach problems,
such as stomach and intestinal bleeding, can occur with or without
warning symptoms. These problems, if severe, could lead to
hospitalization or death. Although this happens rarely, you should
watch for signs that you may have this serious side effect and tell
your doctor right away.
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Serious allergic reactions
including swelling of face, lips, tongue, and/or throat which may
cause difficulty breathing or swallowing occur rarely but may
require treatment right away.
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Serious kidney problems
occur rarely, including acute kidney failure and worsening of
chronic kidney failure.
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Severe liver problems
occur rarely in patients taking NSAIDs. Tell your doctor if you
develop symptoms of liver problems. These include nausea, tiredness,
itching, tenderness in the right upper abdomen, and flu-like
symptoms.
Bextra
On April 7, the Food and
Drug Administration requested that Pfizer suspend sales of BEXTRA
in the United States. As a result, BEXTRA will no longer be
available to patients in the United States.
The FDA is requiring
all manufacturers of prescription non-steroidal anti-inflammatory
arthritis medicines to provide additional information about
cardiovascular and gastrointestinal risks. The FDA is also asking
all the manufacturers of over-the-counter NSAIDs to revise their
labels to include more information on cardiovascular,
gastrointestinal and skin risks.
Why will BEXTRA no longer be
available?
In light of the FDA's position that there is an increased cardiovascular
risk for all prescription non-steroidal anti-inflammatory arthritis
medicines, as well as the increased rate of rare, serious skin reactions
with BEXTRA, the FDA has requested that sales of BEXTRA be suspended. |
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The FDA expressed concern
that side effects of the arthritis drug outweighed any benefits.
Clinical studies indicate that Bextra patients are more than twice as
likely to suffer a heart attack or stroke compared to those taking a
placebo.
This evidence, combined with
information that the drug can cause a fatal skin disease known as
Stevens Johnson Syndrome, led the FDA to conclude that Bextra did not
possess a favorable risk-benefit profile.
In January 2005, the
American Heart Association announced results of a study that showed a
threefold risk of serious cardiovascular problems in some Bextra
patients. A study reported in the New York Times in November 2004 also
linked Bextra with increased numbers of heart attacks and strokes.
"This is a time bomb waiting
to go off," Dr. Garret A. FitzGerald, a University of Pennsylvania
cardiologist and pharmacologist, told The New York Times after
presenting the study data. "The magnitude of the signal with Bextra is
even higher than what we saw in Vioxx.”
Vioxx and Bextra News
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