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The music selection title for this page is appropriately titled "ALL THAT JAZZ" from "CHICAGO!" - the music is supposed to play when the page loads, b
NOTE: There seems to be a real 'black hole' as far as MEDIA information provided regarding RIMADYL after about 2001. I have not had much luck in getting "reporters" very interested in the subject, despite [or perhaps because] the canine holocaust continues, but you must draw your own conclusions on that.
|Saturday, January 08, 2005 commentary:|
NSAIDs kill 16,500 Americans each year, damage intestines of 70 percent of patients
Here's more drug safety research coming from Dr. David Graham. It shows that over-the-counter painkillers (NSAIDs) like aspirin and ibuprofen, cause widespread damage to the intestines. Intestinal bleeding from these medications kills at least 16,500 Americans each year according to this research (the actual number, though, is estimated to be over 40,000 each year). If you find this article interesting, be sure to also read 'Aspirin and painkiller drugs cause widespread stomach ulcers.'
December 3, 2004 [posted at doghealth2 on 12/06/04] NOTE: all of this information is extremely OUTDATED!]
You might call it a made-for-TV drug.
By CHRIS ADAMS
Staff Reporter of THE WALL STREET JOURNAL
Approved for human use in the U.S. but not marketed that way, an arthritis medicine called Rimadyl languished for nearly 10 years in developmental limbo, then emerged in a surprising new form: Instead of a human drug, it was now a drug for arthritic dogs. And it became a hit.
With the aid of slick commercials featuring once-lame dogs bounding happily about, Rimadyl changed the way veterinarians treated dogs. “Clients would walk in and say, ‘What about this Rimadyl?’ “ says George Siemering, who practices in Springfield, Va.
Today, those TV spots are gone. The reason has to do with dogs like Montana. [the TV ads were pulled in 2000, after Jean Townsend had filed the class-action lawsuit]
A six-year-old Siberian husky with stiff back legs, Montana hobbled out of a vet’s office in Brooklyn, N.Y., six months ago accompanied by his human, Angela Giglio, and a supply of Rimadyl pills. At first, the drug appeared to work. But then Montana lost his appetite. He went limp, wobbling instead of walking. Finally he didn’t walk at all. He ate leaves, vomited, had seizures and, eventually, was put to sleep. An autopsy showed the sort of liver damage associated with a bad drug reaction. [Angela's beloved Montana is on the ADE Memorials as #33, needlessly euthanized after receiving Rimadyl in August, 1999.]
Pet drugs are big business—an estimated $3 billion world-wide—and Rimadyl is one of the bestsellers. It has been given to more than four million dogs in the U.S. and more abroad, brought Pfizer Inc. tens of millions of dollars in sales, and pleased many veterinarians and dog owners. But the drug has also stirred a controversy, with other pet owners complaining that nobody warned them of its risks.
Montana’s owner, Ms. Giglio, is among them. After she informed Pfizer and the Food and Drug administration of her relatively youthful dog’s death, Pfizer offered her $440 “as a gesture of good will” and to cover part of the medical costs. Insulted by the offer and a stipulation that she agree to tell no one about the payment except her tax preparer, she refused to sign and didn’t take the money. “There’s just no way in my conscience or heart I can release them from blame,” she says.
After reports of bad reactions and deaths started streaming in to the FDA, the agency suggested that Pfizer mention “death” as a possible side effect in a warning letter to vets, on labels and in TV ads. Pfizer eventually did use the word with vets and on labels, but when given an ultimatum about the commercials --mention “death” in the audio or end the ads—Pfizer chose to drop them.
Pfizer’s director of animal-products technical services, Edward W. Kanara, says that when reports started coming in, “we acted extremely promptly based on the information we had.” Pfizer points out that reported adverse events involve less than 1% of treated dogs. [be advised that all dogs dying and/or damaged after receiving RIMADYL are considered to be "statistically insignificant" according to PFIZER's view]
Since Rimadyl’s 1997 launch, the FDA has received reports of about 1,000 dogs that died or were put to sleep and 7,000 more that had bad reactions after taking the drug, records and official estimates indicate. The FDA says such events are significantly underreported.
While the numbers include cases “possibly” related to Rimadyl, it is hard to be sure. Many dogs given the arthritis drug are older, and few are autopsied after they die. Pfizer says it analyzed cases of Rimadyl treated dogs that died in 1998 and found a link to Rimadyl to be “likely” in 12% of cases and “not likely” in 22%; it says there was too little information for a judgment about the others.
Despite these problems, the FDA says Rimadyl deserves to be on the market, provided vets take the proper precautions. These include advising dog owners what bad reactions to watch for and periodically doing liver-function or other lab tests.
Within a few weeks, Pfizer will begin affixing a safety sheet directly to packages of Rimadyl pills. It is the first time either FDA officials or Pfizer can recall such a step being taken in the world of animal drugs.
Rimadyl—generically carprofen—is an anti-inflammatory medicine. Developer Roche Laboratories expected to market it for people in 1988 and received FDA approval, but shelved the plan after concluding the market for such drugs was too crowded. In addition, some outside experts expressed concerns; a commentary in a pharmaceutical journal noted unusual liver-function readings in 14% to 20% of test subjects and opined that “until additional data on carprofen are available, older compounds should probably be tried initially.”
The idea of switching the product to the animal-drug track soon arose. A couple of corporate transactions later, it ended up in the hands of Pfizer’s animal-drug unit.
There, it was treated to the kind of sophisticated marketing Pfizer does well. A survey of 885 dog owners was done. Besides shedding light on favorite dog names (Jake, Ginger, Lady), the poll revealed that one-fifth of dog owners would be willing to spend “whatever it took” to buy an aging dog an extra year or two of life. No fewer than 53% agreed that “my dog is a better companion than other members of my family.”
The FDA requires safety and efficacy testing for animal drugs just as for human ones, but animal-drug tests are smaller. Pfizer says about 500 dogs got Rimadyl in various trials, which is no more than a fifth of the number of subjects in comparable human-drug trials. Some dogs showed unusual liver-function readings and one young beagle on a high dose died, but for the most part, the FDA and Pfizer didn’t find side effects alarming. The drug was approved for an early-1997 launch.
That same year, the FDA made it easier to market drugs directly to consumers on TV. Soon, Pfizer was running commercials in which a once-stiff yellow Labrador retriever named Lady bounded over a fallen tree as she fetched tennis balls beside a lake. In another ad, a dog leapt through a window and slid down a banister.
There were also full-page magazine ads and a public-relations campaign, whose results, the PR firm later said, included 1,785 print stories, 856 radio reports and 245 TV news reports “generating 25.5 million positive impressions on the product.”
Early on, vets were floored by the drug’s effects. “The results in some cases have been pretty darn close to miraculous,” says David Whitten of the Hilldale Veterinary Hospital in Southfield, Mich. “I’m using this drug on my own dog. It has been effective. But as with all medications, side effects are certainly a problem.”
The First Complaints
Indeed, within months of the launch, vets at Colorado State University in Fort Collins noticed troubling reactions. Labrador retrievers seemed particularly affected. Since the safety studies for Rimadyl had emphasized testing on young beagles, Pfizer went back to conduct another, small test just on Labs; it says that test showed no particular problem.
Bill Keller, an FDA veterinary-medicine official, notes that “any time you take a product from the investigation and put it into actual practice, you’re going to see things you didn’t expect.” But reports about Rimadyl came in by the hundreds. The FDA had received just over 3,000 animal-drug bad-reaction
reports in 1996, the year before Rimadyl’s launch; in 1998, the drug’s first full year, Rimadyl alone produced more than that many.
They swamped the FDA’s tiny Center for Veterinary Medicine in Rockville, Md. Pfizer was scrambling as well. “Basically, their response,” says Dr. Keller, “was ‘Tell us what you want us to do. We love the fact that it’s selling so well, but we don’t know what to do with all these adverse reactions.’ “
The FDA and Pfizer discussed a “Dear Doctor” letter to be sent to vets. FDA records show the agency found parts of an early Pfizer draft “unacceptable as they are promotional in tone… .” It was revised.
The records also show Pfizer disagreed with the FDA’s suggestion that the letter cite “death” as a possible side effect. To get the letter out, the FDA told Pfizer it was “agreeing to your exclusion of the ‘death’ syndrome from the letter at this time. However, we will revisit the ‘death’ syndrome issue and other potential side effects for possible inclusion in labeling at a later date.” So the term didn’t appear in the first warning Pfizer sent, in mid-1997.
Meanwhile, dog owners were asking for Rimadyl. “It was their advertising that sold me on the drug,” says Michelle Walsh, a Phoenix woman who says her miniature schnauzer was given it and later died.
Not that vets needed much convincing. They saw clear benefits from the drug. On top of that, they could get points from Pfizer for each Rimadyl purchase they made; points were redeemable for PalmPilots, Zip drives for PCs and other equipment. ["clear benefits" have definitely included the perks/incentives and income generated by the use/sales of RIMADYL]
Although Pfizer’s letter told vets to explain to owners the signs of a bad reaction to Rimadyl, such as vomiting, lethargy or diarrhea, it is evident that a great many didn’t. The FDA’s Dr. Keller says, “There are a lot of veterinarians who don’t think they need to take the time, or who forget, or for whatever reason are not providing animal owners with this information.” [the "for whatever reason" must certainly include veterinarian "self protection" from responsibility and/or liability when RIMADYL turns DEADLY]
Donna Allen, whose chow-mix, Maggie, started on Rimadyl last summer, says, “All my vet did was give me this little bag of pills, with no information.” She says Maggie “didn’t want to take it, but I made her.”
After four weeks, Maggie began to vomit violently, Ms. Allen says. The dog vanished from their home outside Birmingham, Ala., and later was found lying in a ditch. Ms. Allen loaded her into a truck and sped 35 miles to a veterinary clinic, but the five-year-old dog died. Her vet wouldn’t implicate Rimadyl in the death until Ms. Allen urged him to send the dog’s internal organs to the University of Illinois vet school, where an examination showed liver toxicity.
Maggie was buried under a marker adorned with the figure of an angel. And Ms. Allen took to the streets, delivering a letter to all the vets in the area urging them to “understand that Rimadyl helps certain dogs, but it is poison to other dogs.”
As the complaints poured in, the FDA told Pfizer it would have to revisit the label issue. Pfizer had referred to “fatal outcomes” on the label as a possible effect of the drug class to which Rimadyl belonged, but not specifically of this drug. Now the agency asked that Pfizer cite “death” prominently as a possible side effect of the drug. Describing the back and forth with Pfizer, the FDA’s Dr. Keller says, “They did it. They weren’t enthusiastic about it, but they have always been cooperative. And that’s part of the nature of the game we play with industry.” [more "games" can be seen with the HUMAN DRUGS currently being discussed in the Senate investigations, including the drug industry criteria of: "clinically insignificant", the definition of which has been provided as: "clinically insignificant is when it happens to comeone else".
HUNG OUT TO DIE via the FDA/CVM's "doggie (body) bag" count aka: ADE reports.
But the FDA also wanted the word “death” in the audio of commercials. Pfizer indicated this “would be devastating to the product,” FDA minutes of a February 1999 meeting show. A company spokesman says that “putting ‘death’ on a 30-second commercial and in proper context was something we didn’t think
was possible.” Rather than do so, it eventually pulled the commercials. [have you gotten any "clues" yet?]
Pfizer says it now will do traditional marketing to vets, making sure they know the proper way to use the drug. Another “Dear Doctor” letter will soon go out, and the company will start attaching a safety sheet to pill packages.
Pfizer acknowledges it has a perception problem with some dog owners; a consumer group, for instance, has mounted a campaign dubbed BARKS, for Be Aware of Rimadyl’s Known Side-effects. The company is contacting dog owners who have told their stories on the Internet, and it is offering to pay medical and diagnostic expenses for some dogs who may have been harmed by Rimadyl.
But Pfizer stands firmly behind the value of the drug, of which it says sales have continued to grow. Most vets also remain strongly behind Rimadyl. Owners, too, generally say they think the drug is important—they just want to know the risks.
Atlantan Roger Williams gave his mixed-breed terrier, William, Rimadyl for more than a year and believes it contributed to the dog’s death. “But if I had to do it all over, I would give my dog Rimadyl again,” he says. “The difference is I would have known what to expect. Without Rimadyl, William was miserable. And what’s the point of living another three years if you’re miserable?”
Write to Chris Adams at firstname.lastname@example.org
Actual Source of this Article The WALL ST JOURNAL
[let me know if you FIND this reporter! ]
To see the report at its source go to http://www.fda.gov/cvm/index/updates/rimadyl2.html and type Rimadyl® in the search engine
Posted by Les Sarnoff
KINK welcomes your feedback: email@example.com
What's wrong with Pfizer? The question gets asked a lot in southeastern Connecticut where several generations of employees, their families and ordinary investors are used to making large profits on the financial success of the big pharmaceutical company. Lately, that hasn't happened. In fact, Pfizer has been fighting to hold its share price, never mind make large gains. Since January, the stock has slipped from $36.50 to $28 plus, a decline of about 21 percent.
But Chairman Hank McKinnell, meeting with analysts a few days ago in Groton, asserted that there's nothing wrong that a few more years of research and new drugs in the pipeline won't cure. In fact, he said that the firm, now swollen by its acquisition of Warner Lambert and Pharmacia, expects to meet its goal of 20 new drugs in the five-year period ending in 2006.
Even by the standards of a behemoth such as Pfizer, that's a great deal of production. It's no secret that Chairman McKinnell, visiting Groton-New London three years ago, had been concerned about the small number of successful new drugs coming into the pipeline from research here. In fact, the absence of enough blockbuster drugs was part of the reason Pfizer acquired the other two large pharmaceutical companies, for they brought with them some blockbuster revenues. For example, Warner Lambert had Lipitor, a cholesterol drug that is the world's largest seller accounted for $2.74 billion in sales in the third quarter alone this year.
But last week, Mr. McKinnell and John LaMattina, Pfizer's president of Pfizer Global Research and Development, talked about the company's improved efficiency and productivity in research. A new, vibrant pipeline of potential drugs has emerged in discovery, they said.
In spending some $140 billion to buy Warner Lambert and Pharmacia, Pfizer in effect raised the stakes on the urgency of producing new blockbuster drugs to pay for the acquisitions and keep earnings growing. And in a maturing research environment, the easier solutions to medical problems have largely been discovered and placed on the market already by the various large pharmaceutical firms. Going forward, the research difficulties increase. But Pfizer says that the combination of data from the acquisitions it made has helped Pfizer understand its own data on various projects. And Pfizer now has about 3 million compounds in its library, a spokesman said.
Of course, the huge array of research scientists now working on drug solutions for Pfizer and the ever-increasing improvements in technology for research speed and efficiency are, in part, an answer to the problem.
Still Pfizer's earnings going forward concern analysts who worry that the huge company may not be able to increase profits at levels experienced in the past. And there are the added concerns about possible price reductions, pressure from the federal government to make drugs available at more favorable prices and drugs that may have negative effects and lead to lawsuits.
Pfizer has two drugs, Celebrex and Bextra, that are Cox-2 inhibitor drugs of the type of Vioxx, which Merck & Co. pulled from drug store shelves last September because of increased heart attacks and strokes among some Vioxx patients. Pfizer said Celebrex and Bextra have different molecular compositions than Vioxx.
In spite of all these concerns, Chairman McKinnell described Pfizer's drug prospects as “sensational” and said that 12 of the 20 new drugs will have been filed with the federal government by year's end. But he made no predictions about earnings in 2005.
Patient investors take note.
What are NSAIDs and how do they work?
Prostaglandins are a related family of chemicals that are produced by the cells of the body and have several important functions. They promote inflammation, pain, and fever, support the function of platelets that are necessary for the clotting of blood, and protect the lining of the stomach from the damaging effects of acid. Prostaglandins are produced within the body's cells by the enzyme cyclooxygenase (Cox). There actually are two Cox enzymes, Cox-1 and Cox-2. Both enzymes produce prostaglandins that promote inflammation, pain, and fever. However, only Cox-1 produces prostaglandins that support platelets and protect the stomach. Nonsteroidal anti-inflammatory drugs (NSAIDs) block the Cox enzymes and reduce prostaglandins throughout the body. As a consequence, ongoing inflammation, pain, and fever are reduced. Since the prostaglandins that protect the stomach and support the platelets and blood clotting also are reduced, NSAIDs can cause ulcers in the stomach and promote bleeding. (NSAIDs do not cause bleeding, but they make bleeding worse, for example, when there is a cut.) NSAIDs differ in how strongly they inhibit Cox-1 and, therefore, in their tendency to cause ulcers and promote bleeding.
For what conditions are NSAIDs used?
NSAIDs are used primarily to treat inflammation, mild to moderate pain, and fever. Specific uses include the treatment of headaches, arthritis, sports injuries, and menstrual cramps. Aspirin (also an NSAID) is used to inhibit the clotting of blood and prevent strokes and heart attacks in individuals at high risk. NSAIDs also are included in many cold and allergy preparations.
Are there any differences between NSAIDs?
Yes. NSAIDs vary in their potency, duration of action, and the way in which they are eliminated from the body. Another important difference is their ability to cause ulcers and promote bleeding. The more an NSAID blocks Cox-1, the greater is its tendency to cause ulcers and promote bleeding. One NSAIDs, celecoxib (Celebrex), block Cox-2 but have little effect on Cox-1. This drug is referred to as selective Cox-2 inhibitors and cause less bleeding and fewer ulcers than other NSAIDs. Aspirin is a unique NSAID, not only because of its many uses, but because it is the only NSAID that is able to inhibit the clotting of blood for a prolonged period (4 to 7 days). This prolonged effect of aspirin makes it an ideal drug for preventing the blood clots that cause heart attacks and strokes. (Most other NSAIDs inhibit the clotting of blood for only a few hours.) Ketorolac (Toradol) is a very potent NSAID and is used for moderately severe pain that usually requires narcotics. Ketorolac causes ulcers more frequently than any other NSAID and is, therefore, not used for more than five days. Although NSAIDs have a similar mechanism of action, individuals who do not respond to one NSAID may respond to another.
What are the side effects of NSAIDs?
NSAIDs are associated with a number of side effects. The frequency of side effects varies between the drugs. The most common side effects are nausea, vomiting, diarrhea, constipation, decreased appetite, rash, dizziness, headache, and drowsiness. NSAIDs may also cause fluid retention, leading to edema. The most serious side effects are kidney failure, liver failure, ulcers and prolonged bleeding after an injury or surgery. Some individuals are allergic to NSAIDs and may develop shortness of breath when an NSAID is administered. People with asthma are at a higher risk for experiencing serious allergic reaction to NSAIDs. Individuals with a serious allergy to one NSAID are likely to experience a similar reaction to a different NSAID. Use of aspirin in children and teenagers with chicken pox or influenza has been associated with the development of Reye's syndrome. Therefore, aspirin and nonaspirin salicylates (e.g. salsalate) should not be used in children and teenagers with suspected or confirmed chicken pox or influenza.
With which drugs do NSAIDs interact?
NSAIDs reduce blood flow to the kidneys and therefore reduce the action of diuretics and decrease the elimination of lithium (Eskalith) and methotrexate (Rheumatrex). NSAIDs also decrease the ability of the blood to clot and therefore increase bleeding time. When used with other drugs that also increase bleeding time, there is an increased likelihood of bleeding complications. Therefore, individuals who are taking drugs that reduce the ability of blood to clot should avoid prolonged use of NSAIDs. Nonsteroidal anti-inflammatory drugs may also increase blood pressure in patients with hypertension and therefore antagonize the action of drugs that are used to treat hypertension.
What are approved NSAIDS in the United States?
The complete list of approved NSAIDs is very long. The following list contains only NSAIDs that are commonly used:
URGENT [but fake] NEWS RELEASE:
|Office of Information and Public Affairs||Washington, DC 20207|
WASHINGTON, D.C.- In cooperation with the U.S. Consumer Product Safety Commission (CPSC), National Service Industries Inc. (NSI), of Atlanta, Ga., is voluntarily recalling about 1.1 million bottles of drain cleaner sold in 64 oz., child-resistant bottles. The bottles can leak, allowing the contents of the cleaner to come into contact with consumers. These cleaners can cause irritation and burns to the skin and eyes.
NSI has received 16 reports of the bottles leaking, including three incidents involving skin irritations to the leg and hand, and 13 incidents involving property damage.
The U.S. Consumer Product Safety Commission is charged with protecting the public from unreasonable risks of serious injury or death from more than 15,000 types of consumer products under the agency's jurisdiction. Deaths, injuries and property damage from consumer product incidents cost the nation more than $700 billion annually. The CPSC is committed to protecting consumers and families from products that pose a fire, electrical, chemical, or mechanical hazard or can injure children. The CPSC's work to ensure the safety of consumer products - such as toys, cribs, power tools, cigarette lighters, and household chemicals - contributed significantly to the 30 percent decline in the rate of deaths and injuries associated with consumer products over the past 30 years.
Due to a conflict of interests that's developed between the CPSC, the EPA and the FDA, there are currently 1.1 MILLION plastic containers of caustic drain de-cloggers available at the FDA warehouse, which PFIZER is actively negotiating to purchase at discount.
LET'S HELP PFIZER OUT [the door]!
Due to the need for PFIZER to come up with a minimum of at least 20 NEW drugs for the FDA to automatically approve on the 'fast track' for marketing in 2005, and to do so without spending additional funds/resources for any legitimate testing of same, the ROMI Foundation proposes the following for consideration:
AutoMune - automatically ensures all natural immunity disappears; totally replaces original system
well. . . . DUH!
RALEIGH, N.C., November 19, 2004—Non-steroidal anti-inflammatory drugs (NSAIDs) are the cornerstone of treatment for many painful conditions in horses, including arthritis, laminitis, and colic. Although these drugs are an important component of therapy for these disease syndromes, overuse and misuse of NSAIDs can result in gastrointestinal injury, kidney damage and even death in horses. Researchers at North Carolina State University’s College of Veterinary Medicine have investigated these drugs in horses with colic-related intestinal injury. This research has uncovered previously unknown adverse effects: NSAIDs actually retard healing of damaged gastrointestinal tissue.
NSAIDs are among the most frequently-used and relied-upon medications in equine medicine. Available in tablet, paste and injectable formulations, their use has been extremely important in the treatment of painful conditions in horses for much of the last 25 years. For example, Butazolidin® (phenylbutazone), commonly known as ‘bute,’ and Banamine® (flunixin meglumine) have dominated the treatment of colic and lameness respectively, although newer NSAIDs such as ketoprofen and naproxen have also been used extensively for these conditions. However, because these drugs are absorbed systemically and are transported throughout the body via the bloodstream, they reach unintended targets where they can have adverse effects. Specifically, there is increasing evidence that two organ systems are particularly susceptible to these drugs: the gastrointestinal tract and the kidneys.
Known adverse effects of systemic NSAIDs
It is now widely recognized that NSAIDs can cause side effects in the gastrointestinal tract, such as stomach ulcers and on rare occasion, potentially fatal conditions such as colitis (severe inflammation and injury of the colon). The kidneys may also suffer damage from these drugs, particularly when horses are dehydrated. Although studies have shown that these complications may be caused by excessive doses of NSAIDs, some horses develop adverse effects when given normal doses. For example, in one study reported by Dr. Noah Cohen at Texas A&M University, five horses evaluated for intermittent colic were found to have right dorsal colitis when taken to surgery, and all had been on normal dosages of phenylbutazone from 5-30 days. In other studies, excessive doses of phenylbutazone have been shown to induce a range of adverse effects within a relatively short period of time, including gastric ulcers, colitis, and kidney damage. Therefore, although a uniform recommendation can be made about careful dosing of horses according to the labeled instructions, owners also need to be aware of the possibility of complications even when they follow these directions. Other factors, particularly dehydration, should alert owners to be especially cautious about administration of even low doses of NSAIDs.
New research raises additional concerns
Recent research conducted by Dr. Anthony Blikslager, associate professor of equine surgery, has yielded surprising results and highlights the complexity of NSAID use. Eight horses with intestinal injury of the small intestine were treated with Banamine®, which is very beneficial for controlling pain and reversing some of the systemic effects of absorption of bacterial toxins from the damaged intestine. Surprisingly, the drug slowed down the intestinal repair process as compared to horses which received no Banamine®, although Banamine® did improve the comfort level of the horses. (None of the horses showed colic signs as they all received the alternative narcotic pain medication butorphanol, trade name Torbugesic®.) Banamine® stopped the intestinal lining from re-sealing for at least 18-hours, which could result in increased endotoxin absorption. According to Dr. Blikslager, “This effect was unexpected because Banamine® is used for its ability to reduce the clinical signs of endotoxin absorption. Now, we need to assess the clinical importance of these findings, and look at safer drugs in the NSAID class.”
New diagnostic methods
While ulcers can cause subtle changes in a horse’s performance, the adverse effects caused by NSAIDs can be quite difficult to detect, so owners and veterinarians need to monitor horses closely during administration. Fortunately, new diagnostic tests are becoming available that can help veterinarians detect problems early. Dr. Sam Jones, associate professor of equine medicine at North Carolina State University’s College of Veterinary Medicine has worked with new diagnostic methods that are paving the way for early detection of problems. “Our awareness of the presence of stomach ulcers has increased dramatically with the availability of new endoscopes that are long enough to reach into the stomach,” notes Dr. Jones. “Ultrasound technology similar to that used to scan tendons has been effective in detecting early evidence of colitis. This allows at-risk horses to be monitored closely before a major problem occurs, and the technology can also be used to monitor the recovery process in horses with on-going colitis.”
What can horse owners do?
When using systemic NSAIDs, horse owners should make sure that they use these drugs in the safest manner possible. “The overall goal of pain management therapy should be to use these drugs at the lowest possible dose for the shortest time possible,” said Dr. Blikslager. “We find that sometimes owners use these drugs in an effort to prevent a problem or to improve a horse’s performance without realizing the potential adverse impact to the horse’s health.”
Unfortunately, there are few outward signs of the initial adverse effects caused by systemic NSAIDs. However, if a horse is being treated with a systemic drug like bute for lameness, and becomes uninterested in food and depressed, gastrointestinal damage could be the reason. The next level of severity would involve episodes of colic or diarrhea. Evidence of any of these findings requires immediate veterinary consultation. The veterinarian may be able to give advice over the phone, but more severe clinical signs warrant immediate attention. Treatment may be as simple as reducing the dose of the NSAID, or taking the horse off NSAIDs completely. More intensive testing at a referral center, involving blood analyses, endoscopy and ultrasound may be required to determine the cause of the problem. Above all else, owners should closely follow the instructions provided by their veterinarian, and immediately alert their veterinarian if they think their horse has a problem associated with systemic NSAID administration.
It is important to note that systemic NSAIDs can be used very successfully, to the point where some horses with chronic lameness receive bute for extended periods of time, typically at a dose such as 1 g once daily. However, even in these horses, it is worth considering giving horses time off from treatment, such as treating only before and after strenuous exercise on a limited number of days per week, or taking the horse off bute periodically to allow organ systems such as the gastrointestinal tract and kidneys to recover.
Drs. Anthony Blikslager and Sam Jones are associate professors of equine surgery and equine Medicine, respectively, in the Department of Clinical Sciences at the College of Veterinary Medicine, North Carolina State University. Their research and outreach efforts are supported by the Colic and Digestive Disease Program at NC State (http://www.cvm.ncsu.edu/docs/ccddp.html). They can be reached by email (Anthony_Blikslager@ncsu.edu, Sam_Jones@ncsu.edu).
It's not "just" dogs that are being killed/damaged by NSAIDs - had true and accurate information regarding these drugs been available on the DOGS, a lot of PEOPLE wouldn't now be going through this!
Media Inquiries: 301-827-6242
The Food and Drug Administration (FDA) today issued a Public Health Advisory summarizing the agency's recent recommendations concerning the use of non-steroidal anti-inflammatory drug products (NSAIDs), including those known as COX-2 selective agents. The public health advisory is an interim measure, pending further review of data that continue to be collected.
In addition, FDA today announced that it is requiring evaluation of all prevention studies that involve the Cox-2 selective agents Celebrex (celecoxib) and Bextra (valdecoxib) to ensure that adequate precautions are implemented in the studies and that local Institutional Review Boards reevaluate them in light of the new evidence that these drugs may increase the risk of heart attack and stroke. A prevention trial is one in which healthy people are given medicine to prevent a disease or condition (such as colon polyps or Alzheimer's disease).
FDA is issuing an advisory because of recently released data from controlled clinical trials showing that the COX-2 selective agents (Vioxx, Celebrex, and Bextra) may be associated with an increased risk of serious cardiovascular events (heart attack and stroke) especially when they are used for long periods of time or in very high risk settings (immediately after heart surgery).
Also, as FDA announced earlier this week, preliminary results from a long-term clinical trial (up to three years) suggest that long-term use of a non-selective NSAID, naproxen (sold as Aleve, Naprosyn and other trade name and generic products), may be associated with an increased cardiovascular (CV) risk compared to placebo.
Although the results of these studies are preliminary and conflict with other data from studies of the same drugs, FDA is making the following interim recommendations:
Non-selective NSAIDs are widely used in both over-the-counter (OTC) and prescription settings. As prescription drugs, many are approved for short-term use in the treatment of pain and primary dysmenorrhea (menstrual discomfort), and for longer-term use to treat the signs and symptoms of osteoarthritis and rheumatoid arthritis. FDA has previously posted extensive NSAID medication information at http://www.fda.gov/cder/drug/analgesics/default.htm.
FDA is collecting and will be analyzing all available information from the most recent studies of Vioxx, Celebrex, Bextra, and naproxen, and other data for COX-2 selective and nonselective NSAID products to determine whether additional regulatory action is needed. An advisory committee meeting is planned for February 2005, which will provide for a full public discussion of these issues.
FDA urges health care providers and patients to report adverse event information to FDA via the MedWatch program by phone (1-800-FDA-1088), by fax (1-800-FDA-0178), or by the Internet at http://www.fda.gov/medwatch/index.html.
The Public Health Advisory is available online at www.fda.gov/cder/drug/advisory/nsaids.htm.
Due to the on-going and non-stop cover-up machinations of the "guilty parties" involved in my own experience, ROMI's "remains" [all of them] are not available.
Please attend ROMI's on-line spirit funeral service at: http://www.thesqueakywheel.com/complaints///complaint5611.cfm
First they killed you; then they cut you up into pieces; now they're hiding all the bits and pieces to cover up their "dirty deeds" - ROMI, you and I answer to a "higher power", just as they will ultimately have to.
May my beloved partner ROMI rest in peace - no matter wherever her bits and pieces/frozen carcass may be held hostage.
[what's in YOUR "urn" ?]
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