November 9, 2007—Merck announced that is has offered $4.85 billion to settle 27,000 lawsuits filed by people claiming injuries after taking Vioxx.
Vioxx was removed from the market in September 2004 after several studies revealed that the drug was associated with a substantially greater risk of heart attacks and strokes. |
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The Food and
Drug Administration (FDA) today acknowledged the voluntary
withdrawal from the market of Vioxx (chemical name rofecoxib),
a non-steroidal 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.
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