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Wireless News - LDR Spine Gets FDA Approval to Conduct Clinical Trial for a Second- Generation Cervical Artificial Disc

admin — Mon, 12 Jan 2009 13:46:03 +0000

Wireless News

02-01-2006

LDR Spine Gets FDA Approval to Conduct Clinical Trial for a Second- Generation Cervical Artificial Disc

LDR Spine announced that it obtained approval for an Investigational Device Exemption (IDE) from the United States Food and Drug Administration (FDA).

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This allows the company to conduct a pivotal human clinical trial to investigate the safety and effectiveness of the Mobi-C …

Read the rest of this article with a Free Trial at HighBeam Research.

Medical Marketing and Media - Bextra woes boost rivals as treatment options narrow

admin — Tue, 06 Jan 2009 01:41:02 +0000

THE PAINKILLER Mobic saw sharp gains in new users in the days following Pfizer’s withdrawal of COX-2 drug Bextra.
In the week ending April 8, nearly 25 percent of former Bextra patients switched to Mobic, which is jointly marketed by Abbott Laboratories and Boehringer Ingelheim, according to data from Verispan’s Vector One.
Bear Stearns analyst Rick Wise said in published reports that Abbott can expect a 165 percent growth in sales for Mobic now that Bextra has been eliminated from the arthritis market.

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Abbott licenses Mobic from Boehringer Ingelheim, and the two have marketed the drug aggressively to physicians since the Bextra withdrawal. “We have stepped up our detailing and direct-to-physician efforts,” said John Yonsky, a spokesman for Boehringer Ingelheim. “But we haven’t done much with (consumer) advertising in a while.”
Meanwhile, Pfizer’s Celebrex, the only remaining COX-2 drug on the market, received 24 percent of Bextra’s business by the end of the week of the withdrawal, the data showed.
“We believe the net patient losses and gains from Bextra switches to Celebrex will equalize based on the current trend in the COX-2 class since Vioxx’s withdrawal,” said Lehman Brothers analyst Tony Butler. “Some patients may stop using Celebrex because they are fearful of the class, and some Bextra patients will switch to Celebrex.”
At press time, data was not available to indicate whether former Bextra users might turn to OTC medications as an alternative, but results from a recent study suggested the move could be economical for some patients.
A study published April 15 in in the Journal of Arthritis Care & Research suggested the most cost-effective treatment for arthritis pain is to combine OTC NSAIDs like Aleve, Motrin and Advil with stomach-soothing proton pump inhibitors like Nexium, Prevacid or Prilosec. The study was funded by TAP Pharmaceutical, maker of Prevacid.
But the FDA also called for the revision of information for all OTC NSAIDs to include warnings about potential gastrointestinal and cardiovascular risks, and adverse skin reactions including Stevens Johnson Syndrome.
“Tylenol, Motrin, Bactrim, Dilantin and Allopurinol are just a few of the marketed products known to have been associated with Stevens Johnson Syndrome in rare cases,” Butler noted.
-Stephen McGuire
Copyright CPS Communications May 2005
Provided by ProQuest Information and Learning Company. All rights Reserved

Chain Drug Review - Boehringer Ingelheim’s Mobic receives FDA clearance

admin — Fri, 02 Jan 2009 15:51:02 +0000

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> The Food and Drug Administration has approved the use of Mobic as a treatment for rheumatoid arthritis. Boehringer Ingelheim Inc. launched the drug four years ago for treating osteoarthritis, the most common form of the disease. Because Mobic is a nonsteroidal anti-inflammatory drug (linked to ulcers and bleeding), the FDA says patients should take doses of Mobic no greater than 15 milligrams (once daily).
COPYRIGHT 2004 Racher Press, Inc.
COPYRIGHT 2008 Gale, Cengage Learning

Internal Medicine News - Generic versions of osteoarthritis drug

admin — Tue, 30 Dec 2008 19:16:02 +0000

The Food and Drug Administration has approved the first generic versions of Mobic (meloxicam) for the treatment of osteoarthritis. The new approvals of 13 generic meloxicam applications stem from the agency’s cluster review approach, aimed at increasing efficiency and decreasing review time for generic drugs.

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In the case of meloxicam, an NSAID, the FDA received more than 20 abbreviated new drug applications.
COPYRIGHT 2006 International Medical News Group
COPYRIGHT 2008 Gale, Cengage Learning

Running & FitNews - New arthritis drug - Mobic - Brief Article - Product Announcement

admin — Sat, 27 Dec 2008 02:46:03 +0000

The real breakthrough was when the COX-2 inhibiting nonsteroidal anti-inflammatory drugs (NSAIDs) first emerged. First was Celebrex. Next came Vioxx. Now there is Mobic (or meloxicam) for the treatment of the symptoms of osteoarthritis. For those who suffer chronic arthritis pain, these drugs were a true innovation. The first generation of NSAIDs worked by inhibiting both COX-1 and COX-2 enzymes because they could not distinguish between the two. COX-2 enzymes are involved in pain and swelling. COX-1 enzymes affect the prostaglandins that protect the stomach and kidneys. The new NSAIDs are smarter because they work only against the COX-2 enzymes–pain relief with fewer gastrointestinal side effects like bleeding. The new drug, Mobic, is expected to be less expensive than the very expensive Celebrex and Vioxx. For those who suffer chronic pain, having more options is good news.

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(Food and Drug Administration, April, 2000)
COPYRIGHT 2001 American Running & Fitness Association
COPYRIGHT 2003 Gale Group

Australasian Business Intelligence - Popular drugs danger warning.

admin — Tue, 23 Dec 2008 06:16:02 +0000

Jun 26, 2005 (The Mercury - ABIX via COMTEX)

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Concerns are being raised about some of the most commonly used medicines in Australia. The arthritis drug Vioxx was withdrawn from sale in 2004, because trials indicated an increased risk of heart attack and stroke, and the Therapeutic Goods Administration has said the same risks exist for people taking more than 200mg a day of the arthritis treatment Celebrex or more than 15mg a day of Mobic. The arthritis treatment diclofenac, often sold as Voltaren, has been associated with a 55 increase in the risk of heart …

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FDA Consumer - Generic drugs for osteoarthritis

admin — Sat, 20 Dec 2008 12:26:02 +0000

The FDA has approved several generic versions of Boehringer Ingelheim’s Mobic (meloxicam) tablets. Meloxicam is indicated for the treatment of osteoarthritis.
“This is another example of our agency’s endeavor to counter rising health care costs by approving safe and effective generic alternatives to brand name drugs,” Gary Buehler, director of the FDA’s Office of Generic Drugs (OGD), said in announcing the July 2006 approval. “Meloxicam is a widely-used nonsteroidal anti-inflammatory drug (NSAID), and its generic versions can bring significant savings to the millions of Americans with osteoarthritis.”

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The approval of meloxicam was the result of a “cluster” review approach, one of the process improvements the FDA has instituted to facilitate the review of generic drug applications. The OGD has begun to review groups of applications submitted at the end of five-year new chemical entity (NCE) exclusivity in “clusters” to increase efficiency and decrease review time. At the expiration of five-year exclusivity, the FDA often receives multiple applications from different sponsors, submitted on the same day.
In the case of meloxicam, the OGD received more than 20 Abbreviated New Drug Applications (ANDAs), and efforts of the FDA’s review team resulted in approval of 13 generic applications for this product in a little over nine months of review time. This is the first time that any generic version of this product has been available.
Because all the patents have expired for Mobic, approval of meloxicam is likely to represent immediate savings to the American public. In 2005, Mobic was ranked 38th in dollar sales of brand-name drugs in the United States, with sales totaling $916,397,000, according to the online magazine, Drug Topics.
Generic drugs are used to fill more than 50 percent of all prescriptions. Because they can cost a fraction of the price of brand-name drugs, the economic impact of the FDA’s generic drug program is significant. With this in mind, the OGD continues working expeditiously to review and take action on generic drug applications.
COPYRIGHT 2006 U.S. Government Printing Office
COPYRIGHT 2008 Gale, Cengage Learning

What You Can Do If You Have Arthritis Knee Pain… Information From An Expert

admin — Mon, 15 Dec 2008 17:56:02 +0000

The most common type of arthritis is osteoarthritis (OA). This article discusses the diagnosis and management of this common problem.

Osteoarthritis (OA) of the knee is one of the most common causes of knee pain in people over the age of 30. The cause is progressive wearing away of the cartilage cushion that covers the ends of the long bones that make up the knee joint. The inflammation that accompanies this process leads to swelling and pain.

Risk factors include family history of osteoarthritis, trauma, misalignment of the knee (leg not being straight), and obesity. Initially the discomfort is described as stiffness in the knees after lying down or sitting. Going up and down stairs as well as getting into and out of a car may be difficult.

OA of the knee can also cause locking, clicking, and a “give-way” sensation in the knee.

Pain at night is also a sign of OA.

The diagnosis is established by careful history and physical examination. Physical findings include tenderness along the joint line, misalignment of the knee (either bow-legs or knock knees), and the presence of joint swelling. The hip should also be examined because hip arthritis can also cause knee pain.

Laboratory blood tests will often be ordered to rule out other causes of arthritis. In addition, the physician will often draw fluid off the knee to analyze it.

While x-rays may be ordered to determine the extent of cartilage wear, they may be normal early on in OA. Magnetic resonance imaging (MRI) is a much more sensitive method for detecting OA of the knee but is expensive.

Treatment of OA of the knee depends on the extent of symptoms. For mild pain, analgesics such as acetaminophen (Tylenol) may be sufficient. Stronger analgesics such as tramadol (Ultram) or propoxyphene (Darvon) may be more effective.

However, for those people who do not respond to acetaminophen or tramadol, the next option is low doses of non-steroidal anti-inflammatory drugs (NSAIDS). Examples of these drugs include ibuprofen (Advil), ketoprofen (Orudis) and naproxen (Aleve). These drugs may be purchased over the counter. More severe or persistent pain may require a prescription NSAID such as etodolac (Lodine), nabumetone (Relafen), dicloflenac (Voltaren), meloxicam (Mobic), and celecoxib (Celebrex). A note of caution: all NSAIDS have been associated with a slight increase in risk as far as cardiovascular events (heart attack and stroke) are concerned. They should be used with caution in patients who have a history of underlying heart disease. Also because of other reasons, they should be used with great caution in patients who have a history of ulcers or significant liver and kidney disease.

At the same time as medicines are introduced, a patient should be started on ice (ice packs) applied to the knee for 20 minutes twice a day. They should also start quadriceps setting (thigh muscle strengthening) exercises. These are exercises designed to strengthen the quadriceps muscles. The stronger these muscles are, the less pain a patient will experience.

Dietary supplements such as good quality forms of glucosamine and chondroitin may be helpful.

Injections of glucocorticoids (steroids) into the knee can be quite useful for symptomatic patients. Another type of injection- hyaluronic acid (Hyalgan, Supartz, Euflexxa, Orthovisc, Synvisc) may be indicated. Hyaluronic acid mimics the effects of the normal synovial fluid produced by the healthy knee. These injections reduce pain, provide lubrication, and may slow down the rate of cartilage deterioration.

Inserts in shoes may help with knee alignment issues and therefore can lead to pain relief.

Weight loss for patients who are obese is important. Low impact aerobic exercise (swimming, a stationary cycle, walking) accompanied by thigh strengthening and stretching are also effective for reducing pain.

Finally, braces and sleeves worn over the knee can also reduce pain that occurs with weight-bearing. Special types of braces that “unload” the part of the knee that is narrowed from arthritis can relieve symptoms in many patients.

Arthroscopy, which is a procedure where a small telescope is inserted into the knee and used to remove damaged or diseased tissue, is another potential option. Finally, patients who have pain that is associated with severe loss of cartilage from the knee may be candidates for knee replacement.

Is The Fox Guarding The Henhouse?

admin — Wed, 10 Dec 2008 18:31:03 +0000

About WebMD
WebMD Health Corp. (Nasdaq: WBMD) is the leading provider of health information services, serving consumers, physicians, healthcare professionals, employers and health plans through our public and private online portals and health-focused publications. WebMD is a subsidiary of Emdeon Corporation (Nasdaq: HLTH). The WebMD Health Network reaches approximately 30 million visitors a month through its leading owned and operated health sites that include WebMD Health, Medscape, MedicineNet, eMedicine, eMedicine Health, RxList and theheart.org.
The National Dairy Council’s web site states that “American milk and dairy products are among the safest and most highly regulated foods in the world” and that milk from hormone-treated cows has repeatedly been shown to be “safe for human consumption.”
A farmer who would like to convert his farm to organic produce only would have to come up with nearly $20,000 dollars for an average size farm which would be smaller than a conventional farm. The cost comes from regulatory licensing paid to the federal government (to be USDA Certified). Don’t you think the Federal government should subsidize farmers who want to grow whole foods? Why do they make it so expensive for farmers to provide Americans with what is clearly a healthier choice? No hormones or pesticides and genetically altered vegetables would find their way onto the shelves of your local supermarkets. And why are conventional farms (users of pesticides, chemicals, genetically altered produce) heavily subsidized by the government, using our tax-dollars? Shouldn’t these federal agencies be looking out for us? The National Dairy Council is comprised of government employees that tell you of studies done showing milk from hormone-treated cows is safe for human consumption.
Webmd is 85% owned by Emdeon Corporation. This mission statement is taken from the home-page of their website.
“Our mission is to provide revenue cycle and clinical communication solutions that simplify the business and improve the delivery of healthcare. Our solutions are designed to provide providers, payers, and patients not only with connectivity, but also the information and data necessary to:”
Improve patient collections Insure rapid, accurate payment processing Increase effectiveness of the clinical encounter
Does this sound like a caring organization? Or does it sound like a company interested in their bottom line?
The drugs listed below are listed on Webmd as treatment for certain symptoms. None of them cure any disease but they do have terrible side effects, including, but far from limited to cancer. Are you taking any of these?
Atenolol Ativan Cymbalta Effexor Hydrocodone Lexapro Lipitor Lisinopril Lyrica Mobic Naproxen Neurontin Norvasc Oxycodone Paxil Prednisone Percocet Prozac Seroquel TOPAMAX Tramadol Vicodin Wellbutrin Xanax Zoloft
Every month the FDA is forced through tort litigation to list drugs that are causing multiple deaths. And every month more drugs are approved by this same FDA. They are shooting us with the gun and telling us where the bullets are coming from. Things aren’t right anymore in this country and it’s only getting worse. The wrong people are in dangerous positions, all the way to the presidency, do not think things will improve. People need to educate themselves as to what is really going on around them. It isn’t too late to make things better, but it’s got to be up to the majority-and that’s up to you and I. Don’t trust your government to do the right thing, they’re too content to allow you to die. That’s the truth.
Graham
http://www.gillfinn.mionegroup.com

Drug Store News - Arthritis: direct medical costs reach $51 billion

admin — Wed, 03 Dec 2008 19:26:03 +0000

The latest figures show that roughly 43 million American adults–about 1-in-5–have arthritis diagnosed by a doctor, making it the leading cause of disability in the United States. This number is projected to increase to 67 million by 2030.
Each year, arthritis results in 750,000 hospitalizations and 36 million out-patient visits. Around 9,500 deaths are attributed to arthritis, and direct medical costs amount to more than $51 billion. Another $35 billion in costs result from loss of earnings. About 23 million people are said to live with chronic joint symptoms, but have not been diagnosed by a doctor.

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Leading drugs used to treat rheumatoid arthritis include Amgen’s Enbrel, Centocor’s Remicade and Abbott’s Humira. According to IMS Health, only 10 percent of diagnosed patients are treated with one of these anti-TNF drugs, so growth within this class of drugs is expected to continue as physicians become more familiar with the drugs. IMS predicts that Enbrel and Humira will especially benefit from growth, as unlike Remicade, they are self-administered.
Sales of Remicade are therefore expected to slow down or decrease by 2010. According to 2005 figures, Enbrel (etanercept) is ranked 11th among the leading U.S. products in terms of sales, achieving sales of $2.7 billion and 36 percent growth. Remicade (infliximab) is ranked 20th, achieving sales of $2.2 billion and 12 percent growth.
Recent COX-2 withdrawals mean they are no longer among the top 10 leading classes of drugs and have thrown the prescription market for drugs to treat osteoarthritis, the more common form, into a tailspin–nothing has really stepped in to pick up the lost COX-2 dollars, suggesting that many people are living in discomfort. Even OTC pain relief has yet to see the lift many suppliers expected in the wake of the COX-2 troubles. In 2005, total sales of Bextra and Celebrex reached $1.76 billion compared with total COX-2 sales of $5.4 billion in 2004, when Vioxx was still on the market. Among traditional NSAIDs, Mobic was the top seller in 2005, achieving sales of $1.94 billion.
Anti-TNF drugs in the pipeline include UCB’s Cimzia (certolizumab pegol), which is expected to be approved for use to treat RA in 2007, and Centocor’s golimumab, which is in phase II trials for RA and has shown good clinical results, according to IMS.
In March this year, Roche received approval for the use of MabThera (Rituxan) in RA patients who fail to respond to anti-TNF therapy. The company has another potential RA drug, Actemra (tocilizumab), in phase HI trials. Also this year, Bristol Myers Squibb launched Orencia (abatacept), a T-cell co-stimulation modulator, for patients who fail to respond to other disease-modifying drugs, including methotrexate. Both Mabthera and Orencia are expected to reach blockbuster levels (in excess of $1 billion) in sales, according to IMS.
COPYRIGHT 2006 Reproduced with permission of the copyright holder. Further reproduction or distribution is prohibited without permission.
COPYRIGHT 2008 Gale, Cengage Learning