Each tablet of VIOXX for oral administration contains either 12.5 mg, 25 mg, or 50 mg of rofecoxib and the following inactive ingredients:.
Approximay 3600 patients with osteoarthritis were treated with VIOXX; approximay 1400 patients received VIOXX for 6 months or longer and approximay 800 patients for one year or longer. The following table of adverse experiences lists all adverse events, regardless of causality, occurring in at least 2% of patients receiving VIOXX in nine controlled studies of 6-week to 6-month duration conducted in patients with OA at the therapeutically recommended doses (12.5 and 25 mg), which included a placebo and/or positive control group.
Eyes, Ears, Nose, and Throat: allergic rhinitis, blurred vision, cerumen impaction, conjunctivitis, dry throat, epistaxis, laryngitis, nasal congestion, nasal secretion, ophthalmic injection, otic pain, otitis, otitis media, pharyngitis, tinnitus, tonsillitis.
Digestive System: acid reflux, aphthous stomatitis, constipation, dental caries, dental pain, digestive gas symptoms, dry mouth, duodenal disorder, dysgeusia, esophagitis, flatulence, gastric disorder, gastritis, gastroenteritis, hematochezia, hemorrhoids, infectious gastroenteritis, oral infection, oral lesion, oral ulcer, vomiting.
Cardiovascular: cerebrovascular accident, congestive heart failure, deep venous thrombosis, hypertensive crisis, myocardial infarction, pulmonary edema, pulmonary embolism, transient ischemic attack, unstable angina.
Urogenital System: breast mass, cystitis, dysuria, menopausal symptoms, menstrual disorder, nocturia, urinary retention, vaginitis.
They are supplied as follows:.
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Who says advertising doesn't work? Of the top-selling drugs in 2011 viii, led by Lipitor, Nexium, Plavix, Advair Diskus, Abilify, Seroquel, Singulair and Crestor, none is taken occasionally, or "as needed" and the treatment goal is never to get off the drug, like an antibiotic.".
What would you say if you knew someone had killed 60,000 people? Would you call it a felony of the worst kind, times 60,000? If you totaled up the value of all those lives in criminal court, what would you say they're worth? Billions? Trillions?
An important strategy for creating a true blockbuster drug—at least in the United States—is the use of direct to consumer advertising.
Yet that's the plea agreement Merck recently made with a federal court in Boston on April 19 ii, after being charged with illegal promotion of Vioxx for treatment of rheumatoid arthritis, before it was approved for that use.
According to a report by ABC11 x :.
Rofecoxib was approved by the U.S. Food and Drug Administration (FDA) on May 20, 1999, and was marketed under the brand names Vioxx, Ceoxx, and Ceeoxx. Rofecoxib gained widespread acceptance among physicians treating patients with arthritis and other conditions causing chronic or acute pain.
Some commentators have noted that naproxen would have to be three times as effective as aspirin to account for all of the difference, and some outside scientists warned Merck that this claim was implausible before VIGOR was published. Merck's scientists interpreted the finding as a protective effect of naproxen, ling the FDA that the difference in heart attacks "is primarily due to" this protective effect. No evidence has since emerged for such a large cardioprotective effect of naproxen, although a number of studies have found protective effects similar in size to those of aspirin.
Furthermore, a more recent meta-study of 114 randomized trials with a total of 116,000+ participants, published in JAMA, showed that Vioxx uniquely increased risk of renal (kidney) disease, and heart arrhythmia.
In September 2001, the FDA sent a warning letter to the CEO of Merck, stating, "Your promotional campaign discounts the fact that in the VIGOR study, patients on Vioxx were observed to have a four to five fold increase in myocardial infarctions (MIs) compared to patients on the comparator non-steroidal anti-inflammatory drug (NSAID), Naprosyn (naproxen)." This led to the introduction, in April 2002, of warnings on Vioxx labeling concerning the increased risk of cardiovascular events (heart attack and stroke).
In May 2000, executives at Merck, the pharmaceutical giant under siege for its handling of the multibillion-dollar drug Vioxx, made a fateful.
It also took place amid a fierce battle between Vioxx and Celebrex in which federal regulators said marketing claims ran ahead of the science. The decisions about how to test Vioxx were made in a hothouse environment in which researchers fiercely debated how the question should be pursued, and some even now question whether the drug needed to be withdrawn.
For Merck, the Vioxx episode has been bitter.
And, they say, they were open to the possibility that Vioxx was at fault. Company executives and researchers say that from the moment they were told in March 2000 about the preliminary results from the Vigor trials, they sought every possible explanation for the signs of increased cardiovascular risk.
Konstam in a recent interview.
Learn the history of the once popular NSAID pain reliever, Vioxx. Read about Merck's withdrawal of Vioxx due to its link to heart attacks, strokes & death.
Used to Treat: Pain and inflammation.
Vioxx (rofecoxib) was the second drug of its kind to enter the United States market, directly competing with Celebrex, manufactured by Monsanto and co-marketed by Pfizer Inc. and touted as the second-most-prescribed arthritis drug at the time. Merck introduced Vioxx as a part of a relatively new class of drugs known as COX-2 selective NSAIDs or COX-2 inhibitors, which boasted fewer gastrointestinal adverse effects than nonselective NSAIDs, such as ibuprofen.
However, that same study also consequently revealed its higher rate of heart attacks and other cardiovascular risks.