Some say media reports about Vioxx, others are overblown
January 11, 2005 12:18

For both doctors and patients, choosing the best pain-killing medication has become a real pain.

http://www.gainesvilletimes.com/news/stories/20050111/localnews/66638.shtml

In October, Merck voluntarily pulled its popular arthritis drug Vioxx off the market after studies showed it could raise the risk of heart attacks. Celebrex and Bextra, two other drugs in the same category known as COX-2 inhibitors, are under suspicion as well.

And just last month, it was announced that over-the-counter medicines such as naproxen (Aleve) and ibuprofen (Advil) might also be linked to heart problems. The Food and Drug Administration has ordered a broad review of all anti-inflammatory drugs to re-evaluate their safety.

... She had been taking Vioxx for arthritis until her insurance company stopped reimbursing for it. Then she decided to manage her condition with diet and exercise.

... "Over-the-counter pain relievers have been around forever, and now suddenly they're a problem?" she said.

Brown thinks Vioxx was withdrawn not because of the actual harm it might cause, but because its manufacturer was afraid of lawsuits. ... estrogen might be linked to heart attacks and cancer, the drugs weren't taken off the market.

...

"What's an acceptable level of risk?" he said. "One in a million (patients with fatal reactions)? One in 10 million? Common sense has to rule. But I think consumers are running scared."

...To his knowledge, none of Stewart's patients experienced heart attacks or strokes from taking Vioxx. Yet he feels pulling it off the market was the right decision.

"There were real concerns about Vioxx," he said. "Unfortunately, I think Celebrex and Bextra will probably end up getting pulled as well, even though in small dosages their risk is minimal."

The COX-2 inhibitors were hailed as a major advance because they cause less stomach upset and gastrointestinal bleeding than the older anti-inflammatories. ..."I can't tell you how many patients I had who did well on Vioxx and had no problems," she said. "I also have several who have not done as well when I switched them from Vioxx to Celebrex or Bextra."

As for questions about the safety of naproxen, Gibbs said, "It's hard to make heads or tails of what to tell patients. You really have to look at each study individually, and each practitioner has a different opinion."

...

"If I have a patient with known heart disease, I'd prefer to switch them from Aleve to Tylenol until we have more information."

http://www.contracostatimes.com/mld/cctimes/living/health/10616491.htm

Q: I value your opinion and hope you can get to my question. My aunt takes SAMe for osteoarthritis pain. She says that brands like Nature Made work better, because they are natural rather than synthetic. What does this mean?

A: This issue is generally misunderstood and merits some discussion. A chemical compound consists of atoms in a specific structural configuration. At this molecular level, the body recognizes and uses the compound the same way, whether it's manufactured in nature or in a chemical laboratory. In short, one is no better than the other. The only difference is that natural sources (foods and plants) provide a countless array of nutrients and substances in addition to a particular one you might be interested in. Extracting a certain compound from its natural source, or synthesizing it in a lab, enables a large amount of the pure compound to be put into a pill that can be swallowed. Ingesting the same amount from a natural source would generally require consuming an impractically large load. That said, whether you might need significantly more of a particular vitamin, mineral, phytochemical or other substance than is provided in a balanced diet of natural foods is a separate issue. SAMe (short for S-adenosylmethionine), the supplement your aunt takes, is a naturally occurring compound the body manufactures as needed. Nature Made rightfully uses the words "naturally occurring" in its product description, and your aunt may have read unwarranted meaning into this phrase. Because foods provide scant amounts of SAMe, a supplement is required to get appreciable quantities. Substantial evidence suggests that SAMe is effective for osteoarthritis, the "wear and tear" type of arthritis that many people develop as they age. SAMe also seems to work for clinical depression. In fact, the depression sometimes seen with Parkinson's disease might be related to the depletion of the body's SAMe levels by levodopa, a drug commonly used to treat this disease. However, by this same mechanism, SAMe given as a supplement might reduce the effectiveness of levodopa. Back to your aunt's osteoarthritis: The supplements glucosamine and chondroitin are much less expensive than SAMe, and have as much or more evidence backing them for osteoarthritis. All three supplements appear to be about as effective as NSAIDs in alleviating the painful joint symptoms of osteoarthritis. Additionally, and unlike NSAIDs, glucosamine and chondroitin appear to actually slow the progression of the disease. SAMe might also provide this benefit, but the evidence for it is preliminary. Mounting evidence implicates the COX-2 specific NSAIDs Vioxx, Bextra and Celebrex (at higher doses) in raising cardiovascular risk. Surprising recent findings, though preliminary, suggest that this risk might extend to traditional NSAIDs (naproxen). All things considered, these supplements may be safer alternatives for many people with osteoarthritis. Keep in mind that they may require several weeks to exert their full effects.

Ask Monheit Law, "Do I have a Celebrex Case?"

For more information, contact:
Michael Monheit, Esquire, Monheit Law, PC

Painful News Consumers who've reverted to good old aspirin, ibuprofen or naproxen because of sometimes-conflicting health warnings about the newer painkillers Celebrex, Bextra and Vioxx may need to think again: A new study shows that regular use of those traditional nonsteroidal anti-inflammatory drugs (NSAIDs) substantially increases risk of ulcers and bleeding in the small intestine. The new findings add insult to injury for users of naproxen (Aleve), which was recently cited for possible ties to heart trouble, too.

A Peek Inside NSAIDs have long been linked to stomach bleeding, (resulting in anemia and even death), but their effect on the small intestine has been hard to determine. David Graham, a gastroenterologist at the Michael E. DeBakey VA Medical Center in Houston, had 21 regular NSAID users and 20 people who used either acetaminophen products (such as Tylenol) or nothing to treat their arthritis pain swallow endoscopic cameras. Resulting pictures showed that 71 percent of NSAID users suffered small-intestine injury. Only 10 percent of the control group had such injuries, and theirs were comparatively minor. None of the participants in the study -- which appears in the journal Clinical Gastroenterology and Hepatology -- showed or felt outward symptoms of the intestinal problems.

Ditch the NSAIDs? Not so fast. "If I were a patient, I'd just kind of file this away for now," said Graham. (He is not the David Graham of the Food and Drug Administration, who blamed the agency recently for trying to suppress findings of Vioxx's heart-disease risks.) "We really need to rethink the whole situation as to how to use pain drugs most effectively." Tylenol is not an NSAID, but it has its own risks, including liver damage if a dose is too high or is taken with alcohol. Risks of any drug must always be weighed against benefits; consult your doctor before changing a regimen.

-- Jennifer Huget http://www.washingtonpost.com/wp-dyn/articles/A64431-2005Jan10.html

Of the 181 drugs, which includes Vioxx, Pfizer painkillers Celebrex and Bextra are a top concern, Wolfe said. The group plans to petition the FDA as early as next week to remove both drugs from the market, he said.

HALTED two studies involving Pfizer Inc.'s Celebrex and naproxen, sold by Bayer AG under the brand name Aleve... Of the 181 drugs, which includes Vioxx, Pfizer painkillers Celebrex and Bextra are a top concern, Wolfe said. The group plans to petition the FDA as early as next week to remove both drugs from the market, he said...

At a time when the safety of pain medications such as Vioxx, Celebrex, and Aleve are being publicly questioned, millions of people have nowhere to turn for relief. Or do they? A new technique is allowing at least some pain sufferers to give themselves a safe and possibly effective alternative from a new source ? their own subconscious mind.

(PRWEB) January 14, 2005 -- At a time when the safety of pain medications such as Vioxx, Celebrex, and Aleve are being publicly questioned, millions of people have nowhere to turn for relief. Or do they?

Contact Information:
Ben Plumb, CEO
352-376-7095
 

ROCKVILLE, Md., Jan. 12, 2005 - The Food and Drug Administration today posted a letter on its website sent to Pfizer Inc. on Jan. 10, 2005 regarding various advertisements regarding Celebrex and Bextra.
http://www.pharmalive.com/News/index.cfm?articleid=204316&categoryid=57