LifeCare Chiropractic

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Celebrex

Eleven Deaths Among UK Vioxx Users – (10-16-00)

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Eleven Deaths Among UK Vioxx Users

The new selective COX-2 inhibitors Vioxx and Celebrex have been touted as a new panacea for arthritic disorders. Although the incidence of ulcers does appear reduced, we still cannot view these drugs as completely safe.

(article) Eleven deaths and more than 1,000 reports of suspected adverse reactions to Merck’s new osteoarthritis drug Vioxx (rofecoxib) have been reported in the UK since its launch in June last year, British regulators said on Thursday. Five patients died following gastrointestinal reactions, three following cardiac failure and three following myocardial infarction, the agencies reported in their newsletter “Current Problems.” An estimated 557,100 prescriptions for Merck’s COX-2 inhibitor have been dispensed in the UK up to the end of May 2000, the agencies said. The rate of reported adverse reactions is therefore approximately one per 500 prescriptions. The newsletter reminded prescribers that rofecoxib is contraindicated in patients with active peptic ulceration, GI bleeding, and severe congestive heart failure. It also noted that “caution should be exercised in patients with a history of cardiac failure, left ventricular dysfunction, or hypertension and in patients with pre-existing oedema for any other reason”. In conclusion, the agencies said, “As with all new drugs, the safety of rofecoxib remains under close review.” They pointed out that another COX-2 inhibitor, Pharmacia’s celecoxib (Celebrex), had been launched recently and promised to report on its safety profile in a forthcoming bulletin. Merck officials were not immediately available for comment.

Celebrex Has No Safety Advantage Over NSAIDs, Panel Says – (02-15-01)

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Celebrex Has No Safety Advantage Over NSAIDs, Panel Says

Celebrex’s manufacturer’s are not going to like this. The new selective COX-2 inhibitors where designed to be safer on the stomach (don’t forget that NSAIDs can also damage the liver, kidneys, GI tract other than the stomach, as well as the joints themselves…). But post-marketing studies do not support the advocacy of safer stomachs, primarily with concomitant use of aspirin. And remember, the population that is most likely to be continued users of “arthritis drugs” will also be more likely to be taking an aspirin a day for heart disease prevention.

(article) A postmarket study of celecoxib, conducted by the drug firm Pharmacia, failed to establish the drug’s safety superiority to nonsteroidal anti-inflammatory drugs (NSAIDs), an advisory panel to the US Food and Drug Administration (FDA) determined on Wednesday. The Arthritis Advisory Committee met here to discuss whether findings from Pharmacia’s extensive Celecoxib Long-term Arthritis Safety Study (CLASS) trial proved that celecoxib is safer than ibuprofen and diclofenac, and whether COX-2 inhibitors taken with aspirin may pose a health risk that warrants further study. The panel agreed that Pharmacia had not established a “clinically meaningful” safety advantage over NSAIDs and that data from the CLASS study would not support a superiority claim at present. According to the committee, the ability of the CLASS study to demonstrate a better safety profile was hindered by one compelling factor: concomitant aspirin use. Although the trial showed an overall twofold reduction in gastrointestinal complications in celecoxib-treated patients, that trend was reversed among subjects who took also low-dose aspirin. Among aspirin takers, celecoxib did not demonstrate safety superiority over ibuprofen or over pooled NSAIDS da….

 

Reduced susceptibility to ischemic brain injury in COX-2-deficient mice – (02-02-01)

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Reduced susceptibility to ischemic brain injury in COX-2-deficient mice

Selective COX-2 inhibitors such as Celebrex and Vioxx are the new rage in treatment of joint pain. There have been some additional findings in research studies, suggesting a protective effect on colon cancer. This study, although done in mice, suggests a reduction in the damage sustained during an ischemic stroke when COX-2 is not even present. Don’t let this convince you to run out and start taking Celebrex; instead, consider this as yet additional evidence that inflammation is a contributing factor to most diseases and you would do well to maintain a lifestyle that reduces inflammation.

PNAS — Abstracts: Iadecola et al. 98 (3): 1294

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Cyclo-Oxygenase 2 Function Is Essential for Bone Fracture Healing – (10-03-02)

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Cyclo-Oxygenase 2 Function Is Essential for Bone Fracture Healing

This is a clinical decision nightmare. The newest arsenal in the fight against arthritis pain is the highly overused class of drugs called COX-2 selective inhibitors (Celebrex, Vioxx). These are supposed to be safer on the GI tract. Recent concerns have arisen over potential damage to the heart with their use, and now we see that the COX-2 enzyme is needed for proper bone healing. How many patients out there are improperly given the selective COX-2 inhibitors for pain relief following joint replacement surgery or fracture? Have to admit that those pharmaceutical reps are doing a good job pushing off-label uses for their drugs!

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The Diabetes Prevention Program – (12-19-02)

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The Diabetes Prevention Program

This large intervention trial was designed to see if lifestyle changes (which were actually pretty general and not nearly inclusive of what should be included) can impact progression to diabetes. The results were a whopping 58% reduction!! And this with only general recommendations. With stronger recommendations and some specific nutrient supplementation, I’m sure the number could skyrocket. Now, the question arises; with such a dramatic reduction available, why are diabetes rates still increasing across all age groups? I still come across patients who have not heard of refined carbs and do not realize that most of their diet consists of them. We need to strongly educate the public about the hazards of this class of processed foods with the ferocity of the new release of Celebrex.

Dia Care — Abstracts: The Diabetes Prevention Program Research Group 25 (12): 2165

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RISK OF CARDIOVASCULAR EVENTS DUE TO COX-2 INTAKE – (04-22-02)

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Why do COX-2 inhibitors increase risk of cardiovascular events?

This article nicely reviews potential mechanisms for the increase in cardiovascular events seen with higher frequency in users of these new “superdrugs.” Millions spent developing and advertising for the superior safety profile of Celebrex and Vioxx–only to find an increasing risk of other types of conditions. This is the perfect example of the true guinea pigs of new drugs–the patients taking a new drug for the first decade or so of its use. When a new drug hits the open market this is the first time that particular drug has been used on such a large study and this is when the dangerous side effects often first appear.

The Journal : Current Issue –

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ASPIRIN ACCELERATE DAMAGE TO LINING OF GI TRACT – (10-01-03)

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Interaction of a selective COX-2 inhibitor w/ aspirin and NO-releasing aspirin in the human gastric mucosa

The dominoes of the newest wonder-drug for arthritis pain continue to fall. They don’t mention on those fairy-tale like commercials that combining the new drugs such as Celebrex and Vioxx with aspirin will accelerate damage to the lining of the GI tract. This is a major concern since many patients self-medicate with aspirin in an attempt to lower risk of heart attacks.

PNAS — Abstracts: Fiorucci et al. 100 (19): 10937

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RISK OF ADVERSE GASTROINTESTINAL OUTCOMES – (01-09-06)

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Risk of adverse gastrointestinal outcomes in patients taking cyclo-oxygenase-2 inhibitors or conventional non-steroidal anti-inflammatory drugs

Isn’t this just the biggest kick in the gluts? A new class of drugs, the selective COX-2 inhibitors like Vioxx and Celebrex are born and a market created by clever marketing campaigns to let people know that the “other” anti inflammatories can damage the GI tract. These drugs get handed out like candy, nearly bankrupting healthcare in some countries due to their high cost. Soon the evil side is seen in an increased tendency to clot the blood, leaving tens of thousands dead. Here’s the kicker—it may turn out that this class of drugs is not so good at doing what it was supposed to do better!! Run that by the widows and orphans whose loved ones suffered untimely deaths.

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