Valdecoxib chemical structure
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Bextra

Valdecoxib is a prescription drug used in the treatment of osteoarthritis, rheumatoid arthritis, and painful menstruation and menstrual symptoms. It is classified as a nonsteroidal anti-inflammatory drug, or NSAID, and should not be taken by anyone allergic to these types of medications. more...

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Valdecoxib was manufactured and marketed under the brand name Bextra® by G. D. Searle & Company. It was available by prescription in tablet form until 2005, when it was removed from the market due to concerns about possible increased risk of heart attack and stroke.

Uses

Since its registration, Bextra was prescribed for pain associated with arthritis, menstrual discomfort, and other ailments.

Side-effects and withdrawal

On April 7, 2005, Pfizer withdrew Bextra from the US market on recommendation by the FDA, citing an increased risk of heart attack and stroke and also the risk of a serious, sometimes fatal, skin reaction. This was a result of recent attention to prescription NSAIDs, such as Merck's Vioxx. Other reported side-effects were angina and Stevens-Johnson syndrome.

Pfizer first acknowledged cardiovascular risks associated with Bextra in October of 2004. The American Heart Association soon after was presented with a report indicating patients using Bextra while recovering from heart surgery were 2.19 times more likely to suffer a stroke or heart attack than those taking placebos.

Personal injury

With the removal of the drug from the market, there is expected to be a surge in personal injury claims, many in the form of class action, to seek compensation.

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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.

COPYRIGHT 2005 Reproduced with permission of the copyright holder. Further reproduction or distribution is prohibited without permission.
COPYRIGHT 2005 Gale Group

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