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 VIOXX
HEART ATTACK
LAWSUIT
VIOXX
RECALL ALERT - DUE TO EXCESSIVE RISK OF HEART ATTACKS, SUDDEN CARDIAC DEATHS & STROKES
VIOXX LAWSUIT
EVALUATION
Free
Evaluation Form
Have
you have suffered a Heart Attack or Stroke or lost a
Family member as a result of a sudden cardiac event while
on Vioxx or a few months after last taking Vioxx?
If
so, call us immediately !
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VIOXX
RELATED HEART ATTACKS, SUDDEN CARDIAC DEATH & STROKES
(September
30, 2004) FDA Issues Public Health Advisory on Vioxx as its
Manufacturer Voluntarily Withdraws the Product The Food and
Drug Administration (FDA) today acknowledged the voluntary
withdrawal from the market of Vioxx (chemical name rofecoxib),
a nonsteroidal
anti-inflammatory drug (NSAID) manufactured by Merck & Co.
FDA today also issued a Public
Health Advisory to inform patients of this action and to advise
them to consult with a physician about alternative medications.
Merck is withdrawing
Vioxx from the market after the data safety monitoring board overseeing
a long-term study of the drug recommended that the study be halted
because of an increased risk of serious cardiovascular events,
including heart attacks and strokes, among study patients taking
Vioxx compared to patients receiving placebo. The study was being
done in patients at risk of developing recurrent colon polyps.
"Merck
did the right thing by promptly reporting these findings to FDA
and voluntarily withdrawing the product from the market," said
Acting FDA Commissioner Dr. Lester M. Crawford. "Although
the risk that an individual patient would have a heart attack
or stroke related to Vioxx is very small, the study that was
halted suggests that, overall, patients taking the drug chronically
face twice the risk of a heart attack compared to patients receiving
a placebo."
Dr.
Crawford added that FDA will closely monitor other drugs in this
class for similar side effects. "All of the NSAID drugs
have risks when taken chronically, especially of gastrointestinal
bleeding, but also liver and kidney toxicity. They should only
be used continuously under the supervision of a physician."
FDA
approved Vioxx in 1999 for the reduction of pain and inflammation
caused by osteoarthritis, as well as for acute pain in adults
and for the treatment of menstrual pain. It was the second of
a new kind of NSAID (Cox-2 selective) approved by FDA. Subsequently,
FDA approved Vioxx to treat the signs and symptoms of rheumatoid
arthritis in adults and children.
At
the time that Vioxx and other Cox-2 selective NSAIDs were approved,
it was hoped that they would have a lower risk of gastrointestinal
ulcers and bleeding than other NSAIDs (such as ibuprofen and
naproxen). Vioxx is the only NSAID demonstrated to have a lower
rate of these side effects.
Merck
contacted FDA on September 27, 2004, to request a meeting and
to advise the agency that the long-term study of Vioxx in patients
at increased risk of colon polyps had been halted. Merck and
FDA officials met the next day, September 28, and during that
meeting the company informed FDA of its decision to remove Vioxx
from the market voluntarily.
In
June 2000, Merck submitted to FDA a safety study called VIGOR
(Vioxx Gastrointestinal Outcomes Research) that found an increased
risk of serious cardiovascular events, including heart attacks
and strokes, in patients taking Vioxx compared to patients taking
naproxen. After reviewing the results of the VIGOR study and
other available data from controlled clinical trials, FDA consulted
with its Arthritis Advisory Committee in February 2001 regarding
the clinical interpretation of this new safety information. In
April 2002, FDA implemented labeling changes to reflect the findings
from the VIGOR study. The labeling changes included information
about the increase in risk of cardiovascular events, including
heart attack and stroke.
Recently
other studies in patients taking Vioxx have also suggested an
increased risk of cardiovascular events. FDA was in the process
of carefully reviewing these results, to determine whether further
labeling changes were warranted, when Merck informed the agency
of the results of the new trial and its decision to withdraw
Vioxx from the market. FDA News Release 9/30/04
VIOXX
RECALL- WITHDRAWAL UPDATE
The
pharmaceutical company Merck & Company pulled the arthritis
and pain medication Vioxx from the worldwide market Thursday
-September 30, 2004, after data from a clinical trial showed
an increased risk for heart attacks and strokes. According
to Merke, they are taking this action because they believe
it best serves the interests of patients," the chairman,
president and chief executive officer of Merck, Raymond Gilmartin,
said in a statement on the company's Web site. People taking
Vioxx are advised to speak with their doctor about switching
to another drug or treatment. Merck says it will reimburse
patients for any tablets they currently have.
Vioxx
was first marketed as an anti-inflammatory drug that reduced
internal inflammation causing pain in the body. It has been
on the market since FDA approval in 1999. The product is marketed
under the trademark Ceoxx in some countries and worldwide sales
amounted to $2.5 billion in 2003, according to the company.
The announcement came after a three-year trial designed to
evaluate the efficacy of taking the drug in preventing a recurrence
of colorectal polyps in patients with a history of benign colorectal
tumors, the company said.
Merck
found that after 18 months of treatment, patients taking Vioxx
were at greater risk for heart attacks compared with those
taking a placebo. The results confirmed the findings of an
FDA investigator who reported similar risks with the drug in
August. In that study, Dr. David Graham found that the difference
in heart risk was statistically significant between a recommended
dose of Vioxx, 25 milligrams a day or less, and the drug's
main competitor, Pfizer's Celebrex. Doses in excess of 25 milligrams
a day more than tripled the risk, compared with patients who
had not taken painkillers within the past two months. At that
time, Merck disputed the results of the study.
VIOXX HEART
ATTACKS- LAWSUITS & LEGAL ACTIONS
DID
VIOXX CAUSE YOUR HEART ATTACK OR STROKE ? DID YOU LOSE A LOVED
ONE DUE TO A SUDDEN CARDIAC DEATH ?
If
you or a loved one have been had a Heart Attack or Stroke while
taking Vioxx or if a loved one died from a sudden cardiac death,
then you may have a right to file a individual legal action against
the Merck. Due to the nature of these legal actions and the serious
and devastating problems that a heart attack or stroke can cause,
Vioxx patients are urged to contact an attorney immediately to
discus their legal options.
Call
us for a Free Confidential Consultation. Talk with a Board Certified
Personal Injury Trial Lawyer about your legal rights. No Fees
or Expenses Charged unless we make a Recovery for You.
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Us Toll Free at 1-800-883-9858 or
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