I had a training client that was prone to back spasm's and would take vioxx when a spasm would flare up. I thought I would take a look into this drug and see what side effects my client could expericance while taking this. Here is what I came up with. Thanks to www.drugintel.com for most of this vioxx information.
Vioxx has the dubious distinction of 1st place in the FDA's 'top suspects'
list, as having the most spontaneous side effects reported. Vioxx was developed
as a simple NSAID that would have less potential for gastrointestinal side
effects compared to aspirin, ibuprofen, naproxen,
etc.
Vioxx Facts List:
Vioxx,
Celebrex Expert Witnesses recommended by DrugIntel
Vioxx Drug names:
Vioxx (rofecoxib)
Vioxx approved medical usage: Cyclo-oxygenase II (COX-2)
inhibitor, anti-inflammatory and analgesic for osteoarthritis, severe menstrual
cramps.
Voixx side effects: Serious cardiovascular thromboembolic
side effects (such as heart attacks, angina pectoris, and peripheral vascular
events)
Company Made By:
Merck
Patient presentation:
Typically myocardial infarction
Vioxx litigation status and lawsuits:
Lauderdale v. Merck & Co., Inc.
Slip Copy N.D.Miss.,2002, Feb. 4, 2002.
Further vioxx info www.drugintel.com
6,994 adverse event side effects reports were filed concerning vioxx. In a
trial of more than 8,000 patients comparing vioxx with naproxen,
the rate of severe upper gastrointestinal bleeding was lower for vioxx but
the rate of myocardial infarct was higher.
Bombardier C, Laine L, Reicin A, Shapiro D, Burgos-Vargas R, Davis B, Day
R, Ferraz MB, Hawkey CJ, Hochberg MC, Kvien TK, Schnitzer TJ. Comparison of
upper gastrointestinal toxicity of vioxx and naproxen
in patients with rheumatoid arthritis. VIGOR Study Group. N Engl J Med. 2000
Nov 23;343(21):1520-8, 2 p following 1528. PMID:
11087881
The incidence of myocardial infarction was lower among patients in the naproxen
group than among those in the vioxx group (0.1 percent vs. 0.4 percent). The
mechanism is not clear, but being obtained in a double blind prospective clinical
trial, this result carries a great deal of weight.
FDA recommends
label changes for Vioxx on Feb. 8, 2001, to add some warnings and recommendations
against using vioxx in obvious cases of ischemic heart disease, and against
using the 50 mg dose chronically.
There are also stomach, liver, and kidney side effects associated with vioxx,
some of which may be traced to the thrombotic embolism problem.
Voixx Update Jan 24 2003: Experts
in the area of Vioxx and Celebrex.
Voixx Update Thursday October 28, 2004: Merck announced results of clinical
trials indicating a reduction in serious, confirmed upper gastrointestinal
side effects for vioxx compared to four widely used NSAIDs. This was the original
rationale for develop this COX-2 inhibitor.
Merck's Arcoxia (Etoricoxib) second generation COX-2 inhibitor, likely to
replace vioxx, is found to have positive results in Phase III clinical trials.
Clinical
results with the other major COX-2 inhibitor on the market Celebrex (celecoxib;
Pfizer-Pharmacia) are not superior to the combination of Cataflam (Voltaren;
Solaraze; diclofenac; Ciba-Geigy/Novartis) plus Prilosec (omeprazole; AstraZeneca)
in not causing new stomach ulcers. The latter combination is not associated
with the same cardiac risk as COX-2 inhibitors, which would thus make it the
logical choice when weighing risk and benefit.
Voixx Update Oct 28, 2004: We find that the excellent report by Oregon Health
& Science University / Oregon Health Resources Commission "June
2002 Non-steroidal Anti-inflammatory Drugs Subcommittee Report" is difficult
or impossible to find on the web anymore, and so we are making it available
in the above NSAID PDF.
See Also Bextra Information
