ROFECOX

“ rofecoxib (vioxx)
Vioxx is a nonsteroidal anti-inflammatory drug (NSAID) that
exhibits anti-inflammatory, analgesic, and antipyretic activities
NSAIDs are a large class of medications used to treat arthritis
pain and inflammation
There are three categories of NSAIDs:
a) Salicylates such as aspirin
b) the traditional NSAIDs
c) the COX-2 selective inhibitors
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“ rofecoxib (vioxx)
⊹ The FDA approved Vioxx in May 1999 for the
reduction of signs and symptoms of osteoarthritis,
as well as for acute pain in adults
⊹ Vioxx has demonstrated significant reduction in
joint pain compared to placebo

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 rofecoxib (vioxx)
 Brand name for Merck’s anti-inflammatory drug and
pain medication
 A prescription medicine used to relieve signs and
symptoms of arthritis, acute pain in adults, and painful
menstrual cycles
 It is also related to the nonselective NSAIDs, such as
ibuprofen, Naproxen®, Celebrex® and Bextra®

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 Description of
rofecoxib (vioxx)
 White to off white to light yellow powder tablet
 Oral administration contains either 12.5 mg, 25 mg or
50 mg
 Once a popular class of painkillers that generated
billions of dollars in annual sale
 The drugs work by blocking COX-2 (Cyclooxygenase-
2), an enzyme that inflames the joints

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 vigor
study
⊹ After Vioxx was approved in 1999, Merck created a VIGOR
(VIOXX Gastro Intestinal Outcomes Research) which was designed
to look into GI effects which included stomach ulcers and bleeding

⊹ VIGOR was a randomized, double-blinded study in 8,076 patients

with rheumatoid arthritis requiring chronic NSAID. The patients
were not allowed to use concomitant aspirin or other anti-platelet
drug

⊹ The study concluded that there was an increase of serious

cardiovascular events including heart attacks and strokes, in patients
taking Vioxx compared to patients taking naproxen 6
 Lawsuits against
Vioxx
⊹ The first VIOXX lawsuit, was a wrongful death
case heard in a Texas courtroom. The jury decided
by 10-2 vote on August 19, 2005, that Merck was
liable and awarded $253.4 million to the widow of
Robert Ernst
⊹ Under Texas law the amount is expected to be
reduced to $26.1 million

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Lawsuits against
Vioxx
⊹ Merck eventually settled the lawsuits out of court for
$4.85 billion
⊹ The legal defense for Merck cost them $1.2 billion
⊹ The average plaintiff will receive just over $100,000
before fees and expenses, which usually run between 30-
50%
⊹ The plaintiff’s attorneys will receive almost $2 billion in
fees
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Lawsuits against
Vioxx
⊹ Merck has also had to settle with unions and insurers
for $80 million
⊹ Shareholders of Merck filed suit against the officers of
Merck on behalf of the company and came to an
agreement that the officers would pay $12.5 million in
legal fees

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Thank
you.