Molecular structure of rofecoxib
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Vioxx

Rofecoxib is a nonsteroidal anti-inflammatory drug (NSAID) that was used in the treatment of osteoarthritis, acute pain conditions, and dysmenorrhoea. Formerly marketed by Merck & Co. under the trade names Vioxx, Ceoxx and Ceeoxx, it was voluntarily withdrawn from the market in 2004 because of concerns about increased risk of heart attack and stroke. more...

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Rofecoxib was one of the most widely used drugs ever to be withdrawn from the market. Worldwide, over two million people were prescribed Vioxx at the time. In the year before withdrawal, Merck had a sales revenue of US$2.5 billion from Vioxx.

Rofecoxib was available on prescription as tablets and as an oral suspension.

COX-2 selective inhibitor

Rofecoxib belongs to the group of NSAIDs known as COX-2 selective inhibitors or coxibs (CycloOXygenase-2 InhiBitors). Being COX-2 selective means that these drugs act specifically on one form of the cyclooxygenase (COX) enzyme, namely the COX-2, whereas previous NSAIDs inhibited both COX-1 and COX-2. This specificity allows rofecoxib and other COX-2 inhibitors to reduce inflammation and pain while minimizing undesired gastrointestinal adverse effects - peptic ulcers - that are common with non-selective NSAIDs such as aspirin, naproxen, and ibuprofen.

Interestingly, at the time of its withdrawal, rofecoxib was the only coxib with clinical evidence of its superior gastrointestinal adverse effect profile over conventional NSAIDs. This was largely based on the VIGOR (Vioxx GI Outcomes Research) study, which compared the efficacy and adverse effect profiles of rofecoxib and naproxen. (Bombardier et al., 2000).

Adverse drug reactions

Aside from the reduced incidence of gastric ulceration, rofecoxib exhibits a similar adverse effect profile to other NSAIDs.

Withdrawal from the market

VIGOR study

The VIGOR study, published in 2000, had indicated a significant 4-fold increased risk of acute myocardial infarction (heart attack) in rofecoxib patients when compared with naproxen patients (0.4% vs 0.1%, RR 0.25) over the 12 month span of the study. There was no significant difference in the mortality from cardiovascular events between the two groups. Nor was there any significant difference in the rate of myocardial infarction between the rofecoxib and naproxen treatment groups in patients without high cardiovascular risk. The difference in overall risk was accounted for by the patients meeting the criteria for low-dose aspirin prophylaxis of secondary cardiovascular events (previous myocardial infarction, angina, cerebrovascular accident, transient ischemic attack, or coronary bypass), but who were excluded from taking low-dose aspirin in the initial design study. Once this risk was noted, Merck notified investigators in other rofecoxib studies to modify allow high-risk patients to take low-dose aspirin. (Bombardier et al., 2000)

Merck's scientists interpreted the finding as a protective effect of naproxen in reducing the risk of MI in high cardiovascular risk patients by 80 percent (which some commentators have noted would make naproxen three times as effective as aspirin). The results of the VIGOR study were submitted to the United States Food and Drug Administration (FDA) in February 2001, which led to the introduction, in April 2002, of warnings on Vioxx labelling concerning the increased risk of cardiovascular events (heart attack and stroke).

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Vioxx/Bextra controversy not driving arthritis sufferers to natural sector
From Drug Store News, 5/2/05 by Michael Johnsen

It would stand to reason that if the safety of a whole class of prescription drugs were called into question, maybe people would explore more natural alternatives. It may not be the "good stuff" backed by decades of research from a team of scientists, but the ingredients in many cases have their own pedigree of substantiation, having been used safely in one form or another for hundreds, if not thousands of years.

It would stand to reason.

So when Merck pulled Vioxx off the market in September and when Pfizer acceded to the Food and Drug Administration's request that Bextra likewise be pulled last month, it would make sense that the people to whom 26.9 million prescriptions for those two medicines were dispensed in 2004--according to IMS Health--would seek safer alternatives, whether prescription, non-prescription or natural.

But not necessarily.

Many consumers apparently have opted to suffer through their arthritic aches and pains until the dust settles around all of the safety issues. Consumers steadfast in their use of a cox-2 inhibitor for their relief of arthritis pain now will be funneled toward Pfizer's Celebrex. And sales of most OTC pain relievers positioned against arthritis are showing double-digit incremental growth. But the sale of glucosamine/chondroitin products for the 52 weeks ended March 27 actually fell 3.5 percent to $179.7 million in the drug channel, according to Information Resources Inc. data. Comparatively, sales of Tylenol Arthritis grew 14.4 percent over a similar time period (the 52 weeks ended March 20).

There may be as many as three factors working against the sale of glucosamine and chondroitin products in what otherwise would be assumed a bull market for any natural product positioned against bone/joint improvement.

First, a lot of the former Vioxx and Bextra users already have tried natural supplements. "The typical patient with osteoarthritis makes the diagnosis before they even come in and see me," said Dr. Bill McCarberg, founder of the chronic pain management program for Kaiser Permanente in San Diego. "They already know they have it, and they've already done treatments for themselves prior to seeing me. They'll have started glucosamine because they read about it in the Ladies Home Journal."

That's not to say, however, that former Vioxx/ Bextra users have tried the category and left, necessarily. But it is to say they've tried the category and made up their minds whether supplements positioned against bone/joint health are right for them.

Of course, the four weeks to six weeks it typically takes before consumers begin realizing results may be the second reason why sales of glucosamine and chondroitin supplements are down when, by all accounts, they should be up. Americans typically are plied with a fast-acting, immediate-relief marketing message, so any product that promises less than immediate efficacy faces an uphill battle in gaining consumer trials.

Last, but not least, of all the nonherbal supplements, glucosamine and chondroitin supplements have represented a constant beacon of growth in the past several years even as the bad-news press has nipped away at the confidence consumers once had in other supplements. It may be that sales of glucosamine and chondroitin simply have plateaued.

"It's a commoditized category in G/C," remarked one supplier who asked not to be named. The only thing a supplier can do is introduce proprietary new products that can't easily be duplicated by private label manufacturers. "We're trying to step the consumer up a bit to bring some profit back into the category, but it's not an easy thing to do."

Pharmavite plans to step up its advertising across its CholestOff and TripleFlex supplements for this spring, the company announced last month. Pharmavite has shot a two-minute spot for TripleFlex featuring testimonials from actual supplement users, highlighting the product benefit of supplementing with glucosamine, chondroitin and MSM. "The [direct-response television] format is a win-win proposition," stated Charles Conroy, Nature Made HealthSolutions senior product manager. "Consumers win because DRTV's longer format provides a complete story about how our supplements can help.... Manufacturers win because DRTV allows us to gauge consumer response in real time." And retailers win, because Pharmavite does not field orders for the products featured. Rather, the DRTV ads direct viewers to an 800-number or Web site where they can get additional information (such as where to buy the product) and a $5 coupon.

The segments will air on women-focused cable channels, including Animal Planet, Bravo, CNN, Oxygen and Soapnet.

In addition, suppliers are beginning to look for ways to inject some excitement back into the category with a dose of product innovation.

In 2003, PatentHealth launched a microlactin product called FluidJoint. And NBTY, now the proud owner of Rexall Sundown's Osteo Bi-Flex brand, introduced another microlactin product called Vital Joint in June.

Microlactin works by inhibiting the migration of neutrophils to sore joint space, which helps reduce pain and inflammation. In addition, microlactin marketers point to clinical trials that suggest consumers realize benefits from the bone joint supplement in as little as two weeks. While still not offering the immediate relief, it's a considerable improvement on the amount of time necessary to achieve results from glucosamine and chondroitin.

Welder in the fall launched Lubriflex3, which contains glucosamine, hyaluronic acid and a proprietary blend of antioxidants called Uniflex, adding to its Schiff MoveFree lineup. Like microlactin, Weider is positioning Lubriflex as a faster-acting supplement for the improvement of bone/joint health.

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