Vioxx
Arthritis
affects around 40 million Americans, causing pain and joint deterioration.
So, when Merck & Co., Inc. launched its new ground breaking COX-2
inhibitor drug VIOXX in 1999, it was distributed to more than 30,000 pharmacies
just eleven days after approval.
VIOXX is
Merck's second largest-selling medicine, and it is this fact that leaves
Merck in the middle of 4 federal lawsuits, a number of state lawsuits,
individual claims, and class actions. The FDA issued a "Warning
Letter" to Merck on September 17, 2001 to cease certain marketing
efforts because their promotional activities and materials are "false,
lacking in fair balance, or otherwise misleading in violation of the
Federal Food, Drug, and Cosmetic Act and applicable regulations".
The letter
went on to say that "You have engaged in a promotional campaign
for VIOXX that minimizes the potentially serious cardiovascular findings
that were observed in the Vioxx Gastrointestinal Outcomes Research," referring
to the allegations that link the drug to problems like
heart attacks, stroke, sudden death, and blood clots. The warning letter
indicates that Merck has previously upset regulators. For more Vioxx
lawsuit information click here.
New study comparing
COX-2 inhibitor rofecoxib (VIOXX) with the traditional NSAID
naproxen
Researchers believe that the risk of cardiovascular problems, including heart
attack, stroke, and blood clots, is more than two times higher in people who
use VIOXX than in people who use traditional arthritis pain treatment.
Vioxx
is Merck's second largest-selling medicine, and it is this fact that
leaves Merck in the middle of 4 federal lawsuits, a number of state
lawsuits, individual claims, and class actions. |
Vioxx Lawsuit News
In response to the Vioxx controversy
, FDA asks Congress for ability to require drug label changes
March 1, 2005
After serious Vioxx side effects were discovered, safety warnings were delayed reaching the public because the FDA and manufacturer Merck & Co. had to negotiate what the warning should say.
In response to the Vioxx controversy, the FDA asked Congress on Tuesday for authority to dictate label changes for drugs to end the back and forth with pharmaceutical companies that delayed warnings to Vioxx users about potential risks. The FDA's deputy director for new drugs told the Senate Committee on Health, Education, Labor and Pensions that the Vioxx safety warning lapse was the result of negotiating “how the specific language should be worded.”
Read Full Article....
More Vioxx News...
Vioxx Questions and Answers
Dr.
John Klippel, of the Atlanta based Arthritis Foundation, answers important
questions about the dilemmas patients face with the drugs VIOXX and
Celebrex. The
highly marketed drugs did a good job promoting the benefits of the drug
but were not as forthcoming with the potential risks of the arthritis drug,
used mainly for osteoarthritis sufferers. Now that research is out
showing the potential cardiovascular risks that VIOXX and Celebrex pose,
patients are wondering whom to believe. For
the complete Newsweek Web Exclusive click
here.
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