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Rimadyl (carprofen), Deramaxx (deracoxib), Vioxx (rofecoxib)

Meloxicam (metacam), Zubrin (tepoxalin) and Previcox (firocoxib)

Also: TRAMADOL (Analgesic, Opioid)

FDA Drug Labeling 

pawprints

The above drugs are known as NSAID's (Non-Steroidal Anti-Inflammatory Drugs). There are many more not listed. As with any medication, your dog should be closely monitored for adverse reactions but especially when dealing with NSAID's.

See: DeathByPrevicox_RowdysLastVacation.htm

Even painkillers for dogs have serious risks
by Julie Schmit USA TODAY

Like pain relievers for humans, pain relievers for dogs are big business, improving the lives of millions. And like pain relievers for humans, those for dogs have led to heartache.

Pfizer pioneered the market for dog painkillers when it introduced Rimadyl (carprofen) in 1997. Nearly 15 million dogs have taken it, many for pain from degenerative joint disease, or osteoarthritis.

Rimadyl (carprofen) now has four competitors with more likely. The market for dog arthritis pain medications tops $130 million a year and is growing about 13% a year, consulting firm Wood Mackenzie says.

But 3,200 dogs have died or been put down after taking the drugs, Food and Drug Administration records show. Almost 19,000 dogs have had bad reactions to them.

The FDA says the drugs are safe, if properly used. Drugmakers say fewer than 1% of dogs have bad reactions to them. If not for the drugs, many dogs might be put to sleep sooner, they say.

"In theory, the drugs are safer for dogs than aspirin," says Steve Marks, head of small-animal medicine at the University of Illinois.

Yet the deaths and other adverse events are a reminder that all drugs pose risks, including those for animals. They also underscore that a drug's risks may not be fully known until the drug is widely sold, despite the FDA's stamp of approval.

Several million dogs received Rimadyl (carprofen) before its warning label was updated to add mention of death in rare cases. Number 2 pain reliever Deramaxx (deracoxib), was marketed for a year before its label was so changed.

George, a beloved Lab who died from Rimadyl

Despite stronger warnings and other safeguards, the drugs continue to create controversy. Some dog owners and veterinarians say the drugs are being overprescribed by vets who don't always give risk information to owners and who, like doctors for humans, are often educated on drugs by pharmaceutical companies.

"There are no safe drugs. There are only safe doctors," says Robert Rogers, founder of the Critter Fixer Pet Hospital in Spring, Texas. "The large number of adverse events occur with these drugs because veterinarians don't know how to use them." Drugmakers share the blame, he says. Their sales representatives often fail to present adequate risk information.

Watch doses, interactions

Proper use of dog pain relievers lessens risks, but proper use isn't always the norm. Novartis analyzed 1,680 Deramaxx (deracoxib) adverse-event reports, including 1,257 osteoarthritis cases.

In 59% of osteoarthritis cases, dogs received doses in excess of the approved dose.

In 28% of all the adverse events, the dog was also on another drug, often aspirin. "This is a definite no-no because mixing can cause serious adverse events," Novartis' David Stansfield says.

Dogs should also be checked before and after receiving NSAIDS, says veterinarian Wayne Randolph of Flemington, N.J. Before he puts dogs on NSAIDs, he does blood work, involving 35 tests at a cost of $65, to check a dog's liver and kidneys, and later repeats the blood work.

The dog NSAIDs are FDA-approved to treat pain and inflammation associated with osteoarthritis. Rimadyl (carprofen) and Deramaxx (deracoxib) are also approved to treat post-surgery pain.

Adverse-event reports

Through November 2004, the FDA received almost 13,000 adverse-event reports about Rimadyl (carprofen), far more than for any other dog pain reliever.

Pfizer's database includes almost 20,000 adverse-event reports. The FDA's data include those "possibly" or "probably" linked to the drug. Adverse events for all drugs are believed to be under-reported.

Pfizer won't release Rimadyl (carprofen)'s revenue, but it says Rimadyl (carprofen) has the most reports because it's the oldest and biggest dog pain reliever.

Rimadyl, with a generic name of Carprofen, originated at Roche Laboratories as an anti-inflammatory drug for people. Deramaxx (deracoxib) was developed by Novartis for dogs but was discovered by G.D. Searle, where Celebrex originated.

Both Rimadyl (carprofen) and Deramaxx (deracoxib) are Non-Steroidal Anti-Inflammatory Drugs, or NSAIDs, as is ibuprofen and aspirin for humans. Deramaxx (deracoxib), is also a COX-2 inhibitor, like Celebrex and Vioxx, the pain reliever for people withdrawn from the market in September because of heart attack and stroke risk.

NSAIDs cause many of the same problems in dogs that they do in humans: Vomiting, diarrhea and ulcers are the most common. Reports of heart problems associated with dog NSAIDs are rare, the FDA says.

Before getting FDA approval, Rimadyl (carprofen) was tested in 549 dogs; Deramaxx (deracoxib) in about 700. That's far fewer than the number of subjects in clinical drug trials for human drugs. Erectile dysfunction drug Cialis, for instance, was evaluated in more than 4,000 patients before it got FDA approval.

When it hit the market, Rimadyl (carprofen), was heralded as a "wonder drug" for freeing dogs from pain. Happy, bounding dogs were shown on TV commercials. "No drug in the history of veterinarian medicine has been met with such instant success," says Steve Dale, host of radio show Steve Dale's Pet World.

Rimadyl (carprofen)'s fast start had a dark side: Reports of dogs suffering liver damage and other effects began pouring in. One of those dogs was George, a 12-year-old chocolate Labrador retriever owned by Jean Townsend of Johns Island, S.C.

She saw the Rimadyl (carprofen) ads and asked her veterinarian whether Rimadyl (carprofen) could help George, who, while seemingly healthy, was moving slower. Rimadyl (carprofen) seemed to work, but after several weeks, George sometimes couldn't move. He started vomiting and had blood in his stool. Within 30 days of starting Rimadyl (carprofen) George was put down. An autopsy showed liver damage, ulceration and bleeding.

"I had no earthly idea I was killing my dog," says the 68-year-old retired government worker. Townsend says she wasn't warned of the risks and didn't ask, trusting her veterinarian. She refused Pfizer's offer of $249 and filed a lawsuit in 1999 that was joined by 300 others.

Pfizer settled in 2003 to avoid costly litigation, it says. Each plaintiff received about $1,000. Pfizer didn't admit wrongdoing and says it informed the FDA of side effects as soon as they were reported.

"We were incapable of informing the world of what we didn't know," spokesman Robert Fauteux says. Pfizer updated Rimadyl (carprofen)'s label twice, the last time in 1999 noting that death occurred in rare instances. That year, it stopped TV ads. Today's print ads include the death warning.

Warning signs:

What to watch for in dogs on non-steroidal anti-inflammatory drugs (NSAIDs):

  •  Vomiting

  • Diarrhea, black, tarry or bloody stools

  • Change in drinking or urination

  • Change in behavior, such as depression or restlessness

  • Yellowing of gums, skin or whites of eyes

Owners Don't Always Get Info

Deramaxx (deracoxib) has been used by about 1 million dogs since its 2002 launch, owner Novartis says. The FDA's data include 2,813 adverse-event reports for Deramaxx (deracoxib), including 630 dogs who died or were put down.

Deramaxx (deracoxib) went to market in 2002 with a label saying the drug "was well tolerated" with an adverse event rate comparable to dogs treated with placebos. Once again, adverse events after the drug was sold proved otherwise.

Both drug makers now issue information sheets for dog owners describing the drugs' risks and proper use. Pfizer even attaches the sheet to Rimadyl (carprofen) bottles. But it may not get to consumers because veterinarians frequently repackage drugs into smaller vials. Marks says risk information is rarely discussed with clients. The FDA has said pet owners often complain about not getting the information sheets.

Pooter, a 7-year-old black Labrador, went in for a checkup in February, says his owner Vickie McCullen-Main, 52, of Bethel Springs, Tenn. Pooter's veterinarian diagnosed a respiratory infection, prescribed NSAID Metacam and sent him home with a week's supply of Rimadyl (carprofen) and an antibiotic.

The doctor "never mentioned anything at all about the risks," says McCullen-Main. Nor did he check Pooter's blood to make sure he didn't have weaknesses that would make him a bad NSAID candidate.

Pooter started to drool, lost his appetite and bladder control. Thirteen days after his checkup, he was put to sleep. McCullen-Main says Pooter should not have received medication for pain because, "He didn't have pain."

She doesn't want Rimadyl (carprofen) or the other NSAIDs removed from the market. She just wants people to know, "These drugs have risks."

Understanding Deramaxx®
Smart Drug or Clever Marketing?

Silk, my 9 year old Dobie, injured her left rear leg and was prescribed Deramaxx® which she took for just two days. Needless to say, three days and $1,500.00 dollars later, the specialists are still giving her IV fluids. A scope was performed today by an internal medicine specialist who found that the entire stomach lining had been sloughed off. Her symptoms were violent vomiting which included blood, bloody stool and bleeding from the rectum. IV fluids will be maintained for at least two more days, which will make that a total of 5 days on IV fluids.  Cheryl Hartman As of March 14th, Cheryl's bill for treating Silk is now $3,470.53.

Deramaxx® is a non-steroidal anti-inflammatory (NSAID) marketed by Novartis Animal Health Products. The essence of the Novartis marketing campaign is that because Deramaxx® is a Cox-2 specific NSAID it is both safer and more effective than other veterinary NSAIDs. Claims like this have been disallowed by the Food and Drug Administration for human Cox-2 inhibitors. Cox-2 inhibitors simply trade one set of side effects for another.

As with any NSAID, it is a medicine to be taken wisely since the side effects can include death.

As of February 24, 2003, the Center for Veterinary Medicine of the Food and Drug Administration had received reports of the death of 27 dogs which were possibly linked to Deramaxx®. Reported adverse events typically represent about 10%-15% of actual events.

This website has been created to provide information on using Deramaxx® intelligently and dealing with problems should they arise.

Deramaxx® Information

Rimadyl: News, Views & Advisories

Switching from one NSAID (including aspirin) to another, or from an NSAID to prednisone (or vice versa), can be dangerous. It is best to wait AT LEAST a week in between, preferably longer, before starting the new drug. Fatal reactions to Deramaxx are much more likely in dogs that have been given Aspirin in the preceding 7-14 days.

Zubrin (tepoxalin) Schering-Plough Animal Health Corporation

Who Should Not Take Zubrin? Your dog should not be given Zubrin Tablets if he/she:  Has had an allergic reaction to tepoxalin, the active ingredient of ZUBRIN Tablets - Has had an allergic reaction to aspirin or other NSAIDs (for example, carprofen, etodolac, or phenylbutazone) such as hives, facial swelling, or red or itchy skin. Zubrin

Metacam (meloxicam) Boehringer Ingelheim

Metacam (meloxicam) or Previcox (firocoxib)

Question Posted April 23, 2006
Have any of you been using Previcox in your practice, and if so, what has your experience been?

We use meloxicam extensively as a routine pre and post-op NSAID. This of course made my Merial rep very happy when Merial was distributing meloxicam. Now that Boehringer Ingelheim took over the US marketing of it, my Merial rep wants me to replace all of our meloxicam use with firocoxib.  The meloxicam seems to be working fine, and we like the injectable option for pre-op patients so I see no reason to change it at this time. Dennis Chmiel  from International Veterinary Academy of Pain Management (IVAPM)

Meloxicam (Metacam)
(For veterinary information only)
Brand name: Metacam, Mobic (human use)
Available in 7.5 & 15 mg tablets & oral suspension, and injectable
(the veterinary product is oral suspension and injectable only)

Background:

Meloxicam is a member of the class of drugs known as NSAIDs (non-steroidal anti-inflammatory drugs), the same class as such common over-the-counter remedies as Advil (Ibuprofen), Aleve (Naproxen), Orudis (ketoprofen), and aspirin as well as more controversial prescription drug such as Celebrex (celecoxib) and Vioxx (rofecoxib).

This class of drug is used for pain relief successfully in humans but the development of safe NSAIDs for dogs has only been recently achieved. This class of drug is particularly problematic in cats because of the inability of the feline liver to remove assorted medications from the body.  With the possible exception of aspirin, none of the drugs listed above can be safely used in pets.

The problem with NSAID use in pets has been unacceptable (even life-threatening) side effects. Problems in the past have been related to:

  • Stomach ulceration - even perforation and rupture of the stomach can occur. This is not only painful but life-threatening.
  • Platelet deactivation - platelets are the cells controlling the ability to clot blood and, as a general rule, it is preferable not to promote bleeding. We would prefer platelets to remain active and able to function should we need them.
  • Decreased blood supply to the kidney - this could tip a borderline patient into kidney failure.

The veterinary profession has been in need of an NSAID that could effectively relieve pain without the above risks. In 1997, Pfizer Animal Health released Rimadyl (carprofen) for dogs in the U.S. as the answer to this need. This medication had been available in the U.K. since 1994 and has earned a reputation for effectiveness and safety.

This new plane of safety is made possible by new biochemical knowledge. Inflammatory biochemicals responsible for the pain and inflammation we want to alleviate are produced by an enzyme called “cyclo-oxygenase 2.”  The goal is to inhibit this enzyme without inhibiting its counterpart “cyclo-oxygenase 1.” 

Cyclo-oxygenase 1, abbreviated COX-1, is what is called a “constitutive” enzyme. This means it is involved in producing regulatory biochemicals (called prostaglandins), which are important in maintaining the normal health and function of our bodies. We want to leave this enzyme alone.

Cyclo-oxygenase 2, abbreviated COX-2, produces inflammation but also is important in regulating kidney blood flow and in some reproductive and central nervous system function. In the past, NSAIDs could not distinguish the COX enzymes; they inhibited them both.

With the development of “COX preferential” and “COX selective” NSAIDs, we can inhibit COX-2 and leave COX-1 alone.  The introduction of COX-2 preferential NSAIDs has reduced stomach and intestinal side effects by 50% in humans and has made FDA approval of certain NSAIDs possible for pets.

How this Medication Is Used

Meloxicam is used in the treatment of pain either for short term or long term use. It is used once a day.  It is important to note that the human version of this medication contains a vastly more concentrated form of meloxicam when compared to the veterinary oral liquid. It is easy to overdose a pet with the human product and one should not attempt to substitute the human product for the veterinary product without specific instructions.

A dog that is potentially a candidate for long term use of meloxicam should have a complete examination by the veterinarian, a screening blood panel to establish baseline biochemical values, and ideally some kind of recheck testing two weeks after starting meloxicam. 

This is because most adverse reactions, unusual as they may be, occur within this initial time frame and it is important that they be recognized before they get out of hand.  After this initial period, complete blood panels should be screened every six months, an important step with any medication for long term use, not just the NSAIDs.

Meloxicam is approved only for canine use officially and was designed for long term use in dogs (and humans). Cats represent a special situation. The feline liver does not have the same enzyme systems as other mammalian livers do. This means that a dose of NSAID is stronger and lasts a long time in the feline body (for example, aspirin is commonly dosed for dogs twice a day but for cats it is dosed twice a week.) 

For this reason, NSAID development for cats has been particularly difficult. Meloxicam is approved for one single dose after surgery in cats. It is not approved for long-term use in cats; however, research has found that many cats can take meloxicam with appropriate monitoring and dosing. This typically means administering meloxicam every other day or less. Daily dosing can only be used for a short time (a few days maximum).  Because of feline vulnerability to side effects, be sure you understand dosing instructions from your veterinarian before using this medication in a cat.

Always shake the bottle of meloxicam liquid before dosing.

Side Effects:

The side effects of concern are the same with all NSAIDs: stomach ulceration, loss of kidney function, and inappropriate bleeding.  These are dependent on the dose of medication used and on risk factors of the host (for example: an aged pet may not efficiently clear a dose of medication from its body leading to stronger and longer activity of the drug). 

There is also a particular idiosyncratic reaction for NSAIDs that has received a great deal of press. An idiosyncratic reaction is one that is neither dose-dependent nor predictable by any apparent host factor; it simply happens out of the blue. This particular idiosyncratic reaction is a liver toxicity that is rare enough that it did not show up in any of the initial 400 carprofen test subjects, nor in the U.K., and was not recognized until carprofen was used in over a million dogs in the U.S. after its release as the first NSAID.  We will review this reaction below.

  • The most common side effects of meloxicam are nausea, appetite loss, vomiting or diarrhea. If any of the above are noted, meloxicam should be discontinued and the dog brought in for a liver enzyme and renal parameter blood test. In most cases, the reaction is minor and resolves with symptomatic relief, but it is important to rule out whether or not the patient has more than just a routine upset stomach.
  • If a patient has borderline kidney function, NSAIDs should not be used as they reduce blood flow through the kidneys.  It is also important that NSAIDS not be given to dehydrated patients because of this potential side effect. 
  • The Hepatopathy Side Effect (usually occurs within the first 3 weeks of use)

A carprofen reaction that has received special attention is hepatopathy, a type of liver disease. Symptoms include nausea, appetite loss, and/or diarrhea as well as marked elevations (3-4 times higher than the normal range) in liver enzymes measured in the blood.  The question of whether other veterinary NSAIDs share this reaction has arisen. At this time, it is generally felt that the hepatopathy idiosyncratic reaction is not unique to carprofen and should be of concern with any veterinary NSAID.

Dogs with this syndrome show improvement with support 5 to 10 days after discontinuing medication. It is important that the NSAID be discontinued and the patient evaluated in the event of upset stomach signs in case of this syndrome.

Even though this is a rare syndrome (one in 5000), it can become life-threatening if ignored. Appetite loss or other intestinal signs do not necessarily indicate a hepatopathy but since they might, it is important not to ignore these signs should they occur.  There is no way to predict which dogs will experience this side effect. 

The hepatopathy reaction usually occurs in the first 3 weeks after starting carprofen but could theoretically occur later.

  • All NSAIDs are removed from the body by the liver. If the patient’s liver is not working normally due to another disease or if the patient is taking other drugs that are also removed by the liver, it is possible to “over work” the liver and exacerbate pre-existing liver disease. If there is any question about a patient’s liver function, another class of pain reliever should be selected.

It is important to realize that COX-selectivity is not the sole factor in safety. In humans, the incidence of kidney function-related side effects was unchanged by the development of COX-2 preferential NSAIDs, such as meloxicam, and we expect the same is true with dogs.

Still, these drugs have an excellent track record for safety.  The important issue is to recognize risk factors for adverse reactions and take preventive steps (see the Concerns and Cautions section below). 

Interactions with Other Drugs

Drugs of the NSAID class should not be used concurrently as the potential for the aforementioned side effects increases. For similar reasons, NSAIDS should not be used in conjunction with corticosteroid hormones such as prednisone, dexamethasone, etc. Pfizer recommends a 5 to 7 day rest period when changing from one NSAID to another.

Aspirin poses an exception due to its strong platelet inactivating abilities so 10 to 14 days is recommended when switching to another veterinary NSAID from aspirin. Allow at least one week between prednisone and meloxicam.

If meloxicam is used concurrently with phenobarbital, it is especially important that appropriate liver monitoring be performed. (I recommend bile acids testing every 6 months for dogs on phenobarbital.) These two drugs interact such that neither may work well if they are used together.

ACE inhibitors such as enalapril or captopril may not be as effective in the presence of meloxicam. (ACE inhibitors are used in the treatment of hypertension or heart failure.) This is because ACE inhibitors depend on the dilation of blood vessels in the kidneys and such dilation can be interfered with by NSAIDs).

The most common risk factor for NSAID side effects is concurrent use of a corticosteroid. [Corticosteroid: man-made drugs that closely resemble cortisol, a hormone that your adrenal glands produce naturally. Corticosteroids are often referred to by the shortened term "steroids." Some corticosteroid medicines include cortisone, prednisone, and methylprednisolone. Prednisone is the most commonly used type of steroid to treat certain rheumatologic diseases.]

Concerns and Cautions:

Meloxicam works as well when given on an empty stomach as when given on a full stomach. If a patient has had some upset stomach issues with meloxicam, these can often be minimized by administering the drug on a full stomach.

Maximum effect is seen approximately 8 hours after administration. When beginning a trial course of meloxicam, a response may take 3 or 4 days to show. If no response has been seen in 10 days, meloxicam has failed and a different pain medication should be tried. If one NSAID fails, another may well work (similarly, many people find better relief from ibuprofen over aspirin or vice versa.)

Meloxicam should not be used in pregnancy or in lactation.

Meloxicam has not been evaluated in puppies less than 6 months of age.

Meloxicam should be avoided, if possible, in patients with impaired function of the liver, kidney or heart. It should also be avoided in dehydrated patients and patients with known GI ulcers.

Vioxx Debate Echoed in Battle Over Dog Drugs
by Marc Kaufman - Washington Post Staff Writer - May 12, 2006

The drug came on the market four years ago after being tested in a healthy, young population, although it was intended for use by the old and sick. The manufacturer aggressively advertised it and ultimately made claims deemed by regulators to be beyond what testing had established. (Marcia Angell’s book The Truth About Drug Companies: How They Deceive Us and What to Do About It details this and much more.)

When reports of illness and death linked to the drug surfaced not long after it went on the market, the company was slow to report the problems to the Food and Drug Administration. The agency eventually did issue a reprimand and a formal warning letter, but two years later the drug is still being sold, and some consumers complain that too little is being done to warn pet owners of its dangers. The medication is Deramaxx, and it's the center of another drug controversy. But this medication isn't for people. It's for dogs.

An anti-inflammatory closely related to the human painkiller Vioxx, which was taken off the market in 2004 and is now the subject of thousands of lawsuits against Merck & Co., Deramaxx has helped relieve many canine aches and pains. But in an echo of the national debate over the dangerous side effects of some popular human drugs, Deramaxx has also proved at times to be deadly.

Before the early 1990s, most drugs given to pets were human medications that appeared to help animals as well. But with dogs in particular living longer and being treated increasingly as members of the family, the demand for better drugs has grown, along with the public's willingness to pay for them.

Most companies that now develop and sell pet drugs are subsidiaries or divisions of the major brand-name drug companies, and they must seek FDA approval to market their products much as they do with drugs intended for people.

Deramaxx is not the only drug to run into trouble in the burgeoning world of animal medicine. The widely used ProHeart 6 heartworm treatment was the subject of controversy several years ago and was withdrawn from the market in 2004 following reports that healthy dogs were becoming sick and dying after getting a shot of the preventive medicine. In both cases, the deadly side effects led to formal -- but by many accounts ineffective -- government and industry efforts to warn veterinarians and dog owners of the drugs' risks.

In 1999, 300 pet owners filed a lawsuit against Pfizer Inc., alleging that its early dog arthritis medicine Rimadyl had seriously harmed their pets. Pfizer settled in 2003, saying it had done nothing wrong but wanted to avoid costly litigation. Each plaintiff was given $1,000. The ProHeart 6 case also led to allegations that its manufacturer, Wyeth, had sought to discredit the FDA official overseeing the investigation -- a pattern seen with FDA officials who questioned the safety of human drugs.

Victoria Hampshire, the agency official at the center of the ProHeart 6 controversy, was taken off the case and later became a whistle-blower. Her difficulties were documented on the Senate floor last winter by Sen. Charles E. Grassley (R-Iowa).

Wyeth maintains that it simply gave the FDA potentially troubling information it found on a Web site about a possible conflict of interest involving Hampshire. The agency cleared her after an investigation, and ProHeart 6 remains off the market. Hampshire says she became increasingly alarmed after receiving reports of hundreds of dogs dying soon after receiving the heartworm shots, just as more than 350 reports of deaths linked to Deramaxx have come into the FDA's Center for Veterinary Medicine. As with adverse reactions in people, the number of reported cases is generally believed to represent less than 10 percent of the true total.

Hampshire, who now works in a different FDA division, said she learned about many cases from distraught pet owners such as Demitry Herman, a manager with Lehigh Electric in Allentown, Pa.

"This is really the same thing we saw with dangerous drugs being given to people, but maybe even more unfair because pet owners had no idea these pills could be so harmful," said Herman, who two years ago helped start a Web site dedicated to reporting on adverse drug reactions in dogs Dogs Adverse Reactions -- after his miniature schnauzer died after being given Deramaxx. "If our vet had only told us what danger signs to look for, maybe we could have acted sooner and she wouldn't have had to die the miserable death she did," he said. "We know from our Web site that hundreds or thousands of dogs are dying from their medications, and that most of their owners never even knew there was a danger."

Herman's complaint is one that David Stansfield, director of professional relations for Novartis Animal Health, the maker of Deramaxx, says he understands. He said the company tells veterinarians not only to inform pet owners of possible side effects -- especially stomach problems with anti-inflammatory drugs such as Deramaxx -- but also to conduct blood and sometimes urine tests before the drug is prescribed. Those tests can be expensive, however, and are not routinely done.

Stephen Sundlof, director of the Center for Veterinary Medicine, said the agency believes that pet owners need better information about possible adverse reactions from the drugs their pets are given. But the agency cannot require veterinarians to give out the consumer information drug companies provide, he said. "Some drugs are not as safe as we would like them to be," Sundlof said. "We hear a lot from dog owners who lost a loved pet, and we pay a lot of attention to that. But these drugs appear to be doing a lot of good for a lot of animals, too." Stansfield said that when it comes to treating chronic and acute canine pain, the new medicines are a major step forward. His company has worked hard to improve its reporting of adverse events, he said, because it understands that the benefits come with risks.

FDA's Hampshire, who worked on the Deramaxx and ProHeart 6 cases before losing her position last year, said, "Whatever problems we face with drugs in the human world are magnified in the animal world. There's no pharmacist involved, and so there's no monitoring of prescriptions. And, of course, the patient can't talk and tell you he doesn't feel right." Hampshire remains concerned about her agency's response to reports of serious side effects. She likens her experience to that of two other FDA whistle-blowers whose concerns about human drugs were not being properly addressed -- safety officers David Graham (Vioxx) and Andrew Mosholder (antidepressants).

"Nobody wanted to believe I was just doing my job; they wanted to think I was off on my own agenda," said Hampshire, who last month won the U.S. Public Health Service's award for veterinarian of the year. "I think a lot of people [in the agency] didn't want to hear what I was saying." Because veterinarians dispense animal drugs themselves, their role is at the center of the debate.

The FDA's Sundlof and Novartis's Stansfield said their organizations are working with veterinary groups to encourage practitioners to do more to warn clients about possible side effects, and that many vets are responding.

But many veterinarians resist efforts to force them to share drug information sheets -- provided by the companies and endorsed by the FDA -- with pet owners. Elizabeth Curry-Galvin, interim director of the scientific activities division of the American Veterinary Medical Association, said vets are trained to discuss possible drug side effects with pet owners, and her organization thinks most do so. She said the association opposes efforts to require vets to give out the drug makers' information because "it's just not the be-all and end-all of the communication that's needed."

Bills that would require distribution of the sheets have been introduced in South Carolina and Pennsylvania. The South Carolina measure was defeated in 2004, but the Pennsylvania legislation, sponsored by state Sen. Michael J. Stack, is pending.

Because of his experience with Deramaxx and later what he considers foot-dragging by the state veterinary medicine board, Herman is pushing hard for a consumer's seat on that board. "Drugs are needlessly injuring and killing hundreds of dogs every year," he said, "and some of us are really upset about that."

Any dog on long term medication of any kind should have blood chemistry and enzyme level rechecks every six months.

"The blood pressure related side effects that have made COX-2 selective NSAIDs controversial in humans are not significant factors in canine use." Wendy C. Brooks, DVM, DipABVP Educational Director, VeterinaryPartner.com  

The blood pressure side effects are what have resulted in human deaths so are we not to be concerned with using these drugs for our dogs? Mel~K911.biz

pawprints

Tramadol and Its Possible Side Effects

Tramadol Info from Wikipedia

Brand names: ConZip, Ultram, Ryzolt

Drug classes: Analgesic, Opioid

Hi, After After reading the article on the K9 Kidney Forum at Yahoo, I want you to know that Tramadol is not necessarily as safe in canine use as people may think.

My dog 'Angel' had CRF and  also needed long-term Meloxicam treatment for a shoulder injury. She was dosed by myself at 50% of the vets recommended rate for 8.5 years  - only ever using the full dose when there were occasional acute flareups because I knew the dangers. Well, as we got into late stage CRF, the vet suggested Tramadol because I didn't want to increase the Meloxicam.

After the first dose of Tramadol (correctly administered for her body weight) Angel developed severe ventricular arrhythmia which nearly killed her. The problem lasted for 36 hours (I don't know where they get 8 from)  until the drug cleared from the system. 

Once I had noticed her heart running like an out of control motor I contacted the vet and also researched Tramadol side effects on line. There was nothing in the Canine literature to support that kind of side effect. However there was a reference in human medicine about tachycardia being a side effect.

Angel died January this year age 13-14 from CRF, I believe she may only have got to 9 if I had given the full dose of Meloxicam all the way through. Tramadol sounded like a good idea, so too did Previcox - fortunately she would not easily let me dose her with pills so Meloxicam remained the preffered pain relief - but none are without potential side effects.

Drugs need to be understood and used intelligently, balancing the potential harm against the likely good they may do. That Tramadol episode taught me that it is my responsibility to check things out rather than rely on vets advice which is based as much on commercial drug trial 'unscientific positive interpretation' as much as anything else.

John (England)   October 11, 2012