The Senior Dogs Project
"Blessed is the person who has earned the love of an old dog."
FAQ's Concerning Rimadyl
Product information presented in these FAQ's was derived from various Pfizer Animal Health releases. Also reflected in this material are reports and E-mail received by the Senior Dogs Project.
What is Rimadyl?
Rimadyl is a non-steroidal anti-inflammatory drug (NSAID) intended for the relief of pain and inflammation in dogs. It is often used for dogs with osteoarthritis, although it is also prescribed in other situations, such as post-operatively for pain. Aspirin is also an NSAID, but does not seem to have as dramatic an effect as Rimadyl and can be more harmful than Rimadyl. Rimadyl was introduced by Pfizer in January 1997 after being approved by the FDA following clinical trials.
Age as a Factor in Use of Rimadyl
I thought Rimadyl was designed specifically for older dogs, since they're most often the ones with arthritis and joint problems. Isn't it especially safe for them?
Pfizer states: "Approximately 70% of possible adverse drug event reports received by Pfizer Animal Health have been in older dogs."
Is it only old dogs that have a bad reaction to Rimadyl?
Adverse drug experiences with Rimadyl have been reported in dogs as young as 15 months.
Even though Rimadyl is recommended for use with older dogs, isn't it true that during clinical trials Rimadyl was not tested on older dogs in particular?
Rimadyl was tested on dogs in a wide range of ages. The studies did not focus especially on older dogs.
My vet told me my dog was just "old," and not having a reaction to Rimadyl. Yet, when I took her off the medicine, she was just fine. How can you tell the difference between old age and a reaction to Rimadyl?
We have had reports of many cases in which veterinarians have pointed to age as the cause of symptoms resembling Rimadyl toxicity. You should contact Pfizer and have them consult with your veterinarian to make the proper determination. In some cases dogs have been euthanized because it was thought their symptoms were age-related and they were beyond help. Rimadyl may have been a factor in a number of these cases, but it is impossible to determine this beyond a doubt.
I know for a fact that NSAIDS are not recommended for older people because the elderly tend to experience more side effects than younger people. Why then is Rimadyl, which is an NSAID, recommended for older dogs?
The choices for pain relief for dogs are limited. Rimadyl is one to try, even if a dog is older, because there aren't many that work.
Administering Rimadyl -- Baseline Tests, Dosage, Frequency, Use with Other Drugs, etc.
If the vet does baseline tests and then prescribes Rimadyl, doesn't that mean my dog won't have a bad reaction to the drug?
A baseline test will tell your vet whether your dog has existing liver or kidney disease, in which case your vet definitely WOULD NOT prescribe Rimadyl. However, baseline tests will not tell the vet whether your dog will experience toxicity to the drug once he starts taking it. There is no way to predict an adverse drug reaction if your dog's liver and kidney functions are normal.
What is the correct dosage for Rimadyl?
Pfizer recommends a dosage of 1 mg per pound of body weight, twice a day. However, it is possible that your dog may get relief on a lower dosage. Many vets are recommending that you use the lowest possible dosage as a possible means of avoiding side effects. A dog can get relief from a lower dosage or from intermittent administration of the drug. We have had reports that using glucosamine, either alone or with chondroitin, or a product such as Cosequin DS, along with Rimadyl, gives relief with a a very low dose of Rimadyl.
I've heard that the lower the dosage of Rimadyl used to get relief, the better the chances of avoiding side effects. How low a dosage can I try with my dog?
One report we've had is of a female German Shepherd Dog who at first had a toxic reaction to Rimadyl. After several variations of dosages and schedules, she now takes only 25 mg per day -- one-half in the morning and one-half in the afternoon, always with food; and she gets no Rimadyl on the week-ends. She has had no setbacks on this regimen. On an alternate-day schedule, she did not do as well.
Is there an absolutely safe dosage of Rimadyl -- one on which my dog could not possibly experience a toxic reaction?
Rimadyl must be administered in a certain dosage to be effective as a pain reliever. Dogs reported to have had side effects have all been on either the recommended dosage or a somewhat lower one that provided relief. At this point, it does not seem that there is any minimum dosage that would provide relief and also be absolutely safe.
In Switzerland, vets were required to follow-up after 14 days with any dog placed on Rimadyl. Given the incidence of deaths and side-effects, wouldn't that be a good policy to institute here in the U.S.?
This is a suggestion that could be made to Pfizer.
I know that Rimadyl is always supposed to be given with food or a meal. Won't this prevent the side effects?
Giving Rimadyl with food will decrease the likelihood of gastrointestinal side effects; however, we have had reports that this is not always true. Some dogs still have gastroinestinal -- and other -- side effects, even when taking the drug with food.
Once my dog starts on Rimadyl therapy, do I need to give it to him every day for it to continue to be effective?
Some owners are experimenting with alternate day therapy. Others are withholding the drug on the week-ends. If your dog still gets relief on a lower dosage, or an alternate-day schedule, or with a week-end off, that is probably the best way to use the drug.
Suppose I decide to stop giving my dog Rimadyl and to use a different NSAID. Can I change from one to the other right away?
It is recommended that you wait two weeks in between withdrawing Rimadyl and starting another NSAID. There is debate about whether and how long any residual amounts of Rimadyl remain in the dog's liver or other organs after withdrawal of the drug.
Are there any medications that should not be used at the same time as Rimadyl?
Rimadyl, as an NSAID, should not be used along with any other NSAID, such as aspirin. It should also not be given along with any corticosteroid, such as prednisone, prednisolone, or dexamethasone. Pfizer notes, as well, that "Rimadyl should not be used in dogs exhibiting previous hypersensitivity to carprofen." (Carprofen is the chemical name for Rimadyl.)
I have heard that some supplements allow a dog to get relief from arthritis while on a very low dosage of Rimadyl. What supplements are these?
A neutraceutical called "Cosequin DS" has been reported to work in combination with Rimadyl, giving relief with a very low and/or intermittent dosage of Rimadyl. Glucosamine and chondroitin may also give the same results with Rimadyl as Cosequin DS. Consult your vet for more information on alternatives and dosages.
Alternatives to Rimadyl
If I can't use Rimadyl, what are my choices?
There have been favorable reports on the use of "nutraceuticals" such as glucosamine and chondroitin in helping relieve the pain and symptoms of arthritis in dogs. Click on "Arthritis: Various Therapies" in the navigation bar at the left for more information.
How do the alternatives compare to Rimadyl? Will they really be effective in helping my arthritic dog?
Rimadyl has been called a "miracle drug" by some dog owners because the effects are quick and dramatic. Rimadyl does not help every dog, however. "Nutraceuticals" and other therapies seem to take longer to work than Rimadyl and their function may be both to relieve symptoms and to have a "disease modifying" effect -- to produce a change in the joint such that cartilage is repaired and synovial fluid increased. "Various Therapies" describes these effects further.
Can I use coated aspirin just like I would use Rimadyl?
Rimadyl is supposed to be safer and to have fewer side effects than aspirin. However, this is not necessarily true for all dogs, and a coated aspirin, such as Ascriptin, may work just as well and be just as safe for your dog.
Which is better -- Rimadyl or EtoGesic?
Like Rimadyl, EtoGesic is a non-steroidal anti-inflammatory drug (NSAID). It can have the same side effects as Rimadyl. EtoGesic, however, is given once a day, which may be more convenient.
Breed as a Factor in Use of Rimadyl
I heard that Labrador Retrievers were particularly susceptible to Rimadyl poisoning. Is this true?
During the first period after Rimadyl was introduced in 1997, there were more reports of adverse drug experiences among Labradors than any other breed. However, that may have been due to the fact that the drug was being prescribed more for Labradors than for other breeds because they have more joint problems. However, the jury is still out on whether Labs are more susceptible than any other breed. One thing seems certain: no breed is immune from potential side effects.
My vet did a blood workup on my dog and said there were no contraindications for using Rimadyl. Doesn't this mean that Rimadyl is safe for my dog?
Even though the blood workup may have shown no liver or kidney problems, this will not predict whether your dog may experience Rimadyl toxicity. The tests simply establish that there are no liver or kidney problems that would make it impossible for your dog to take Rimadyl.
My dog had surgery for stomach torsion about two years ago. Can he take Rimadyl?
A case of severe gastrointestinal reaction to Rimadyl was reported in a dog who had a history of gastric torsion. Although this is not absolutely a contraindication, NSAIDs typically can cause gastrointestinal problems.
My dog had a mildly negative reaction to Rimadyl at first, but I've kept her on it. Can she continue with it?
Even a mild reaction can be a sign of a more serious toxic reaction in the future. Based on reports of such experiences, it is probably best to seek a different type of therapy for your dog.
Downside of Rimadyl
What happens during Rimadyl toxicity?
Rimadyl acts by inhibiting "prostaglandins" that cause inflammation in injured or aging joints. Prostaglandins are also necessary for normal body functions, however. When their production is stopped, normal body functions, such as are carried out in the digestive system, liver, and kidneys, are disturbed. Internal bleeding can occur in the gastrointestinal tract because the stomach lining becomes eroded or ulcerated. Blood flow to the liver can be decreased, causing toxins to build up in the body. The resulting hemorraghing and/or toxicity can lead to death if not reversed in time. Unfortunately, although the drug supposedly is eliminated from the dog's system shortly after administration is stopped, by that time, irreversible damage may have been done.
I know that all NSAIDs have the potential to cause ulcers or gastrointestinal bleeding. Has Rimadyl ever caused so much internal bleeding that a dog died from it?
There have been a number of reports of deaths from internal hemorrhaging while a dog was on Rimadyl.
Where can I get more information about Rimadyl toxicity?
Pfizer's package insert is posted on their website (linked in the navigation bar at the left). Also be sure to read the reports of adverse drug experiences and other information posted on the Senior Dogs Project website (linked at the left).
What are the symptoms of Rimadyl poisoning?
Signs that you should look for are: vomiting, diarrhea, bloody diarrhea or stool, lack of appetite, change in drinking patterns (refusal to drink or excessive water consumption), excessive urination, unusual patterns of urination, incontinence; listlessness or lethargy, hyperactivity or restlessness, aggressiveness; panting, pacing; collapse, paralysis, seizures, disorientation; shedding, hot spots; facial swelling or hives. In addition, a dog may show signs of jaundice such as yellowing of the whites of the eyes, or signs of internal bleeding such as white gums. A vet can test for symptoms such as: urinary infection, gastrointestinal ulceration, elevated liver enzymes or abnormal liver function, bilirubin, renal failure, immune-mediated hemolytic anemia, thrombocyptopenia, and blood loss anemia.
Why isn't there a package insert or "PIL" (Patient Information Leaflet) for Rimadyl such as you get from the pharmacy when you purchase a drug for human use?
There is in fact a package insert for Rimadyl, but veterinarians do not always give it to clients. There also now exists a "Client Information Sheet," separate from the package insert. Again, however, veterinarians do not always offer this to their clients.
Can't you watch your dog closely for signs of toxic reactions to Rimadyl and therefore not risk irreversible injury or death?
Even under close supervision, some dogs have experienced irreversible damage and have died as a result. In part, the problem is that the symptoms can appear very suddenly, whether a dog has been on the drug for one day, several days, a few months, or a year.
I recently learned that NSAIDs can cause photosensitivity in both the skin and the eyes. Is this true for Rimadyl?
We have had reports of squinting and skin problems associated with use of Rimadyl.
At first my dog seemed to improve after we stopped giving him Rimadyl. But then he collapsed and died. Is this typical?
We have had reports that initial signs of improvement are not always followed by recovery.
What should I do if I think my dog has had a toxic reaction to Rimadyl?
Stop the drug immediately. Take your dog to your vet. Be sure your vet has a copy of the latest Pfizer Technical Bulletin concerning Rimadyl. Have your vet call Pfizer and the FDA. Use the toll-free numbers yourself to report to Pfizer and the FDA. Pfizer: 1-800-366-5288 FDA: 1-888-332-8387 (or 1-888-FDA-VETS).
Do all dogs get relief from arthritis pain when they take Rimadyl?
Rimadyl does not necessarily relieve symptoms for all dogs. It also may work for a short time, after which the dog will return to having the same symptoms as he did prior to Rimadyl therapy.
I've heard that it is possible to get a copy of the report Pfizer should have filed with the FDA about my dog's adverse drug experience with Rimadyl. Is this true?
Yes. You are entitled to receive a copy of the ADE report that Pfizer filed with the FDA. The FDA/Center for Veterinary Medicine specifically mentions on their website that you may contact them for a copy, but they do prefer that you call the drug manufacturer (Pfizer) first. If Pfizer is not cooperative or says they will send it and you don't get a copy within a reasonable amount of time, contact the FDA/CVM and be sure to tell them that Pfizer did not honor your request. The numbers to call: Pfizer: 1-800-366-5288 FDA: 1-888-332-8387 (or 1-888-FDA-VETS).
In the case of Viagra, another Pfizer product, the very first death that was related to the drug was widely announced. In the case of Rimadyl, the FDA October 1998 report notes 195 deaths of dogs during 1997 alone. Shouldn't there be a prominent announcement about these Rimadyl-related deaths, just as there has been for Viagra?
The media have been instrumental in publicizing deaths from Viagra. The media clearly deem human deaths more newsworthy than the deaths of dogs.
Grief over Rimadyl Death
I feel like I killed my dog by giving him Rimadyl and not knowing more about it. I forced those pills on him every single day. I am very depressed and can't seem to get over it.
Grieving for the loss of a companion animal is normal, but it is understandable that it is much worse when you feel you have been instrumental in causing your dog's death. It is critical for you to forgive yourself, though. You were trying to help your dog enjoy the best possible quality of life in the best health. Our dogs trust us and depend on us to use our best judgment, and that is exactly what we do, to the best of our ability. You may wish to seek out a support group or counselor to deal with your profound grief and depression. The "doghealth2" E-mail list is one such support group. If you wish to subscribe to this list (it is free and you may unsubscribe at any time), simply click here: subscribe to doghealth2.
Pfizer's Actions Concerning Rimadyl
Pfizer claims that Rimadyl is completely safe. The company makes this claim in television and magazine ads. If this claim weren't true, wouldn't the FDA step in?
The clinical trials and studies that preceded FDA approval of Rimadyl indicated the drug was safe. This information was the basis upon which the FDA allowed Pfizer to market the drug. Since the introduction of the drug in January 1997, the FDA has been instrumental in working with Pfizer to revise the package insert to reflect new information on side effects that have occurred now that the drug is in wider use. The FDA is continuing to monitor the reports of ADE's with Rimadyl. At this time, however, there is no further statistical evidence that Rimadyl falls outside the "safe use" guidelines of the FDA.
Isn't Pfizer doing its best to investigate the reports of adverse drug experiences and deaths due to Rimadyl?
Pfizer is very interested in keeping Rimadyl on the market and obviously would like to make the drug as safe as possible. Their toll-free number is for you to use if you believe your dog has had an adverse drug experience with Rimadyl: 1-800-366-5288
I would like to see Pfizer provide more information and warnings to vets and the public about Rimadyl. Why aren't they doing that?
Pfizer issued a Technical Bulletin concerning Rimadyl in May 1998 and again in August 1999. It is their belief that Rimadyl is a very safe drug. Pfizer states in their Technical Bulletin, "The reported rate of suspected adverse events associated with Rimadyl is low (approximately 0.2%, or 2/10ths of 1% of all dogs treated. . .)."
I asked my vet if he had seen Pfizer's Technical Bulletin. He said he couldn't remember. Then I asked four other vets. None of them seemed to be aware that an updated Bulletin had been issued.
Some have called Pfizer's Technical Bulletin "a masterpiece of corporate lawyer work" and maintain that the manufacturer has not been aggressive in mounting an appropriate campaign to keep vets aware of the product's capabilities and risks in a timely manner. The Technical Bulletin paints a positive picture of the drug even while it mentions the side effects. Even though a vet may have received the Bulletin from Pfizer, he or she may not have paid much attention to its contents since there was no special note attached to it that marked it as "urgent" or "important."
Pfizer's May 1998 Technical Bulletin revised their original recommendations for baseline testing. Pfizer originally recommended tests in two situations: (1) dogs at risk of experiencing side effects; and (2) dogs on Rimadyl for prolonged periods. The May Bulletin simply says the vet should decide on a "case by case" basis. Why is Pfizer giving less guidance to vets and not more?
If you have any doubts at all about your vet's knowledge concerning the administration of Rimadyl, have him or her call Pfizer. Perhaps the change in the Bulletin reflects Pfizer's concern that the previous guidelines did not cover enough cases. Leaving the decision up to your vet on a "case by case" basis seems to imply that there are more factors to consider than the two that were previous described.
I called the FDA about my dog's death to find out if Pfizer had filed a report. It took Pfizer 7 months to do it. In the meanwhile, more dogs are dying from Rimadyl. Is this the way it's supposed to work?
The FDA does have guidelines that indicate an ADE is to be reported as soon as possible. Currently the FDA is still at work on their 1997 report on ADE's with Rimadyl.
It seems to me that it is not right to advertise drugs in a way that "pulls on your heartstrings" and so that they appear to be completely safe when they aren't. Isn't there a law against this?
Pfizer is certainly obeying existing laws that cover advertising drugs. While it is true that Pfizer's Rimadyl ads appeal to the emotional bond people have with their dogs, there is nothing illegal about that. We have seen many objections to the size of print used to announce the side effects of the drug in these ads, and some have recommended that, in the case of Rimadyl, the print size be increased to that used for the health warning on cigarettes. This is an issue on which the FDA would need to rule.
In an article entitled, "Madison Ave. Loves Drug Ads," Susan Headden writes: "Some medical professionals will never be convinced that advertising is a good idea. They fear promotion may lead consumers to pressure physicians to prescribe a drug that's wrong for them. 'Usually it takes longer to explain why I can't give it to them than to write a prescription,' says Stephen Brunton, a Greenwich, Conn., physician who nevertheless resists the urge to prescribe. Ads also encourage the use of new drugs over existing ones--even though the old drugs may be cheaper or more effective. 'What is brought to the consumers' attention,' says Andrea Kielich, a Portland, Ore., internist, 'is not necessarily the best drug, but the drug that has the most money to advertise."
Why does Pfizer advertise Rimadyl in such a way that the side effects are in the smallest possible type size, as to be almost illegible?
Pfizer follows the example of most advertisers in this regard, and works with the FDA to comply with regulations. However, some manufacturers take it upon themselves to print side-effects warnings in the same size type as the other information in their ads.
I was horrified to see an ad for Rimadyl in Wildfowl Magazine. So many hunting dogs are Labs, and I've heard that Labs are more susceptible to Rimadyl toxicity than other breeds. Don't you think that, to advertise in such a magazine, Pfizer should have made the side-effects warnings more prominent in the ad?
This is a suggestion you might make to Pfizer and to the magazine.
Proving Rimadyl Caused an Adverse Reaction
My vet says my dog died from old age and not from Rimadyl. How do I know if she's right?
Your vet initially must have done baseline tests and then a necropsy to establish the cause. Pfizer will help pay the cost of the necropsy, if you believe there is strong evidence that Rimadyl is implicated. At this point, since your dog died quite some time ago, and the tests and necropsy were not done, there is no way to be certain whether your dog died from Rimadyl poisoning.
I've read through many of the reports about the side effects of Rimadyl and, frankly, they don't look very substantial to me. In fact, I think they're a little "alarmist."
The Senior Dogs Project has posted all reports as written. While, in some cases, it is difficult to "prove" that a dog died or suffered from taking Rimadyl, in many cases there is no proof that this is not the case. What is not contestable, however, and much more "alarming" than "alarmist," is the number of veterinarians who seem unaware that there are any side effects related to Rimadyl at all. One informed vet wrote to the Senior Dogs Project: "I am very concerned about the number of incidents of vets misusing Rimadyl (e.g., prescribing it over the phone without even examining the dog)."
You may also be interested in reviewing the Physicians Reporting Network website where veterinarians posted adverse drug experience reports about Rimadyl that eventually led to a change in the Rimadyl label.
Recovery from Toxic Reaction to Rimadyl
My dog had a bad reaction to Rimadyl. She's been off it now for a couple of months, but still doesn't seem to be 100%. Will she ever recover?
It is important to keep monitoring your dog for quite some time after a toxic reaction to Rimadyl. Consult your vet and Pfizer for specific advice in the case of your particular dog. Some owners are planning to have their dogs monitored for as long as a year following Rimadyl toxicity. Unfortunately, some dogs have been left with irreversible organ damage.
My dog was diagnosed with elevated liver enzymes after a course of Rimadyl therapy. Nothing the vet does seems to have brought them down. Is there any alternative therapy I can use to help his liver get back to normal?
There have been some anecdotal reports that "milk thistle" can help restore liver function. This is not a scientifically-proven therapy, but a number of dogs seem to have improved liver function after its administration. It is available at health food stores and at Wal Mart in the pharmacy section with the vitamins.
Are there other kinds of "natural" remedies that might help my dog recover from Rimadyl toxicity?
There is no scientific evidence that "natural" remedies work. However, you may wish to try them, based on the experience of a person whose 14-year-old dog was almost euthanized because the vet did not recognize the signs of Rimadyl toxicity. Jean Werkheiser has used herbs and other at-home supportive therapies to pull her dog through to live another healthful year after his toxic reaction to Rimadyl. She will respond if you e-mail her.
How can I get my dog to start eating again after she lost her appetite from Rimadyl toxicity? She won't eat the prescription food the vet recommended.
Hand-feeding your dog her favorite foods may stimulate her interest in eating. Baby foods have worked for some dogs while others respond to the highly-aromatic supermarket brands of canned dog food. You may have to cook special food for her for a while. In some cases, "force feeding" has been necessary. Consult further with your vet and with Pfizer for specific recommendations.
Statistics of Adverse Reactions to Rimadyl
What are the actual statistics on the incidence of dogs suffering from Rimadyl toxicity?
The statistics published by Pfizer are: All suspected events: 0.2% or 2/10ths of 1% of all dogs treated during 1997. Liver dysfunction: .02% or 2/100ths of 1% of all dogs treated.
Isn't it true that only a very small number of dogs have died from Rimadyl toxicity? Aren't the statistical odds overwhelming that my dog will not be adversely affected?
Statistically it would seem that your dog has a very small chance of experiencing Rimadyl toxicity. However, this does not seem to be much comfort to the guardians of those dogs who have died. The actual number is not agreed upon. The group of concerned dog owners tabulating the deaths has counted 77 (as of August 13, 1998). However, Pfizer does not agree that each of these deaths is attributable to Rimadyl toxicity, even though the dogs had been taking Rimadyl. (Pfizer states that Rimadyl may "unmask" a pre-existing condition, and it is that condition that the dog may have died from rather than the drug. "Old age" is also often cited when a dog dies while on Rimadyl therapy.)
I don't feel we're getting a clear picture of the risks involved with Rimadyl. I've heard of so many cases; yet Pfizer keeps pointing to their statistics showing how safe the drug is. It's been said that only one in ten cases of adverse drug experiences with humans ever gets reported. If that were true about Rimadyl, the statistics would make the drug look a lot less safe.
Pfizer and the FDA are both concerned and Pfizer has recently become more proactive in seeking reports of adverse effects of Rimadyl. Although it may seem as though it is taking a long time for the information to be compiled and released, eventually this will happen.
Upside of Rimadyl
Despite the potential side effects, isn't it true that Rimadyl has helped far more dogs than it has hurt?
Pfizer states that, ". . . first-year anecdotal reports and pre-licensing trials indicate that the vast majority of dogs have benefited from pain relief provided by Rimadyl, and experienced an improved quality of life." Pfizer also notes that " . . . more than one million dogs . . . have been treated with Rimadyl."
Will Rimadyl cure my dog's arthritis?
Rimadyl is not a cure, but in many dogs acts as an effective pain-reliever and anti-inflammatory.
I tried everything to help my dog's arthritis. The vet actually suggested I euthanize her because she could not walk. Nothing worked until Rimadyl. Isn't that a good reason to keep her on it?
If you fully understand the risks involved and are prepared to carefully observe your dog and have your vet monitor her for adverse reactions, then it certainly sounds as though Rimadyl is appropriate. It boils down to benefits versus risks, and surely Rimadyl is a better choice than euthanizing your dog.
Vets and Rimadyl
My vet disagrees, but I think my dog is having a toxic reaction Rimadyl. What should I do?
Call Pfizer right away: 1-800-366-5288. There are several cases reported to the Senior Dogs Project in which the Pfizer vet agreed with the dog's guardian, and it was subsequently determined that the dog had experienced Rimadyl toxicity.
My vet prescribed Rimadyl for my pet, and I trust her. Doesn't she know what's best for my animal?
Your veterinarian depends on reliable information in prescribing medication for your animal. Questions have been raised about whether vets have been adequately alerted to the side effects of Rimadyl, and whether the number and type of side effects are being analyzed and tabulated properly. Your vet's decisions about treatment for your pet can only be as good as the information she has.
Why didn't my vet tell me about the potentially harmful side-effects of Rimadyl?
Your vet should have read the package insert and the Pfizer Animal Health Technical Bulletin and followed the advice: "When any medication is prescribed, owners should be informed of potential drug-related side effects and signs of drug intolerance." Pfizer also recommends: "Once patients are on NSAID therapy, follow-up communication with owners is encouraged."
Why didn't my vet do any baseline tests before prescribing Rimadyl for my dog?
Pfizer does not require that baseline tests be done before the administration of Rimadyl. They recommend as follows: "Baseline and repeat laboratory data should be considered on a case-by-case basis, and are especially valuable in the geriatric dog."
My vet told me he had heard of only one incident of a dog having an adverse reaction to Rimadyl.
Your vet may not have read the package insert or Pfizer's letter or bulletin. The information that Pfizer has distributed mentions 750 cases of side effects and further cites a study in which 21 dogs experienced Rimadyl toxicity. Of those, 17 recovered after Rimadyl was stopped and they received care; 3 died, and 1 was euthanized. Aside from the study cited by Pfizer, it would be important for your vet to learn about the cases reported to the Senior Dogs Project. You may want to print them out and give them to your vet.
Since my dog died from what I strongly suspect was Rimadyl toxicity, I feel I can no longer have confidence in the veterinary community. How can I protect myself and my dogs from veterinary incompetence?
One of the lessons many people have learned from the Rimadyl experience is that it is important to be well informed yourself about any drug prescribed for your animals. Always ask about side effects, and, if your veterinarian tells you there are none, ask again or look elsewhere for information. If your vet seems to be uninformed, you can alert him or her to the information you have obtained on your own.
Rimadyl clearly helps a great many dogs; yet it is suspected to have caused deaths and other serious side effects. What would be the best way for a vet to present information about the drug so that, if it could help my dog, I wouldn't be afraid to use it?
Here is one suggested presentation your vet might make: "Your dog has arthritis. One of the best pain relievers available to us at this time is a drug called Rimadyl. It is a non-steroidal similar to aspirin. In many cases, it has been shown to have fewer side effects than aspirin, and the pain relief is better. However, you need to know that serious adverse reactions have occurred in many different breeds of dogs. Some of the known adverse reactions are: loss of appetite, vomiting, lethargy, panting, diarrhea, mood changes, jaundice, kidney failure, liver disease, and, in some cases, death. These reactions can occur rapidly or can take months to show up, so it is imperative that you watch your dog closely for any unusual reaction(s). If any of these signs show up, stop the drug immediately and call me, or, if I am not available call Pfizer Animal Care. I still think the drug is the best way to go. We can do bloodwork to make sure your dog is healthy, but no matter how normal the blood work is, it doesn't mean your dog won't have an adverse reaction. The blood work is about $50 -- and I strongly recommend it prior to placing your dog on Rimadyl and at regular intervals thereafter to monitor the liver and kidneys."
Questions about The Senior Dogs Project's Coverage of Rimadyl
How did the Senior Dogs Project website come to post reports about Rimadyl?
It was about six months after Rimadyl was brought onto the market in 1997 that the Senior Dogs Project began receiving E-mail about dogs having side effects from the drug. We collected the E-mail in a "hold" folder until it became apparent that the folder was growing in size out of proportion to any other. With concern for the health of senior dogs, we decided to post the reports on a separate page of the Senior Dogs Project website.
We began to format the reports to include details such as a dog's breed (since there seemed to be a trend in Labradors to experience side effects), weight and dosage taken (since there was a hint that a lower dosage caused fewer side effects), length of time on the drug (to see whether this might be a factor), etc. We felt these details would be helpful to those who were using the drug for their dogs, as well as to Pfizer and the FDA's Center for Veterinary Medicine, who we understood had begun to monitor the website.
At the same time that we were posting adverse event reports, we also solicited reports of beneficial experiences. Many good things were being said about Rimadyl, and we felt it was important to balance the presentation of adverse events with those reports about dogs whose lives were extended and who experienced a vastly improved quality of life when taking Rimadyl.
Is it the Senior Dogs Project's intention to alarm people and to discourage them from using Rimadyl? No -- to both. Our intention is only to make information about potential side effects available. With only one exception, all of the side effects that are mentioned in the reports are listed on the Pfizer package insert, website, and consumer information sheet. (The exception is megaesophagus, and the reason there are three reports on the condition is that the esophagus is part of the gastrointestinal tract, and gastrointestinal side effects are known to be associated with administration of a non-steroidal anti-inflammatory drug -- "NSAID" -- such as Rimadyl.)
The list of Rimadyl's side effects that is presented on the Senior Dogs Project website is not exclusive to the website. It also appears in material (the package insert, consumer information sheet, technical bulletins) published by Pfizer -- material that is supposed to be available and/or given to a consumer in any situation in which a prescription for Rimadyl is being written.
We agree with one veterinarian who wrote to tell us it was his experience that, "Rimadyl has helped many more dogs than it has hurt." We would never discourage the use of Rimadyl for any dog it might help. We would, however, always encourage "full consent" in the administration of any drug -- which assumes access to full information about the drug's benefits as well as its potential side effects.
As we recently wrote to a person concerned about Rimadyl's side effects, "We would be distressed if your dog were denied pain relief and an improvement in his quality of life when, in fact, Rimadyl might safely provide it for him."
All drugs have side effects. Why has the Senior Dogs Project covered only Rimadyl?
As with any new drug, information about the side effects of Rimadyl continues to surface. There is usually a delay of almost a year in the FDA's reporting of adverse drug events. The Senior Dogs Project attempts to post reports within two weeks of receiving them.
We have now begun receiving reports about the side effects of another relatively new NSAID called "EtoGesic." However, it is beyond the scope of our website to cover all new drugs, and we do not intend to make a practice of it.
Is it clear in all adverse events reports that appear on the Senior Dogs Project website that Rimadyl caused the dog's health problems or death?
No. We have followed the guidelines of the FDA for adverse event reporting: if it is suspected that a drug may have caused an adverse event, it should be reported. We have also used as a guideline the information published by Pfizer about side effects that are commonly associated with the taking of an NSAID. In some cases, there has been confirmation from the Pfizer veterinarians themselves that Rimadyl was implicated; however, other cases require further investigation to establish a causal relationship. Unfortunately, when a dog has died, a necropsy is necessary to make such a determination, and this is, in most instances, not possible.
Does the Senior Dogs Project believe that Rimadyl should be taken off the market?
No. The Senior Dogs Project believes that the FDA's Center for Veterinary Medicine will continue to carefully monitor the Rimadyl situation and will make that determination, if necessary. To do an adequate and timely job of monitoring, however, may require more staff than the FDA has available. It may be in Pfizer's best interests (as well as those of consumers and their dogs), if Pfizer were to engage an impartial third party organization to investigate all reports of adverse events so that an unbiased assessment of the situation might be made. We believe that Rimadyl could be used more confidently if that were to occur.
Why does the Senior Dogs Project think that seemingly so many severe side effects of Rimadyl have surfaced?
It is our opinion that there are several reasons:
(1) Rimadyl has been very aggressively sold in the veterinary market. In the words of one drug company executive, it has been "oversold" -- meaning that it has been so aggressively marketed that it is being used extremely widely for both essential and non-essential purposes.
(2) Advertising for Rimadyl emphasizes the benefits of the drug in a manner that may discourage a consumer's careful investigation of the drug's potential side effects.
(3) Information about side effects may not be presented adequately -- either by the Pfizer distribution system or by veterinarians to their clients. A mild case of gastrointestinal distress that goes unrecognized as a side effect of the drug can become a major health issue it the drug is not withdrawn.
(4) Appropriate testing (e.g., blood panels) is recommended, but not required, according to the Pfizer package insert. Liver and kidney effects are not an issue if caught in the early stages, provided blood panels are used prior to administration of the drug and on an ongoing basis to monitor the effects. If no baseline testing or monitoring is done, and the drug is continued until externally observable symptoms appear, the effects are usually more severe.
What does the Senior Dogs Project recommend for people who are considering the use of Rimadyl for their dogs?
You should think of your veterinarian as your best ally in your efforts to provide the best health care for your dog. At the same time, you need to act as an advocate for your dog by discussing with your veterinarian your concerns about your dog's health and your observations about his condition; by telling your veterinarian about all medications or supplements your dog has been taking; and by discussing the benefits versus the risks of any therapy or medication your veterinarian prescribes for your dog. You should feel that your veterinarian is someone who welcomes your interest in and questions about your dog's health and treatment program.
Another recommendation we would like to make is that, once you have clarified all the relevant issues about your dog's health with your veterinarian, you adhere to the prescribed therapy and check with your veterinarian before making any changes in the therapy.
What does the Senior Dogs Project think about the role of veterinarians in the Rimadyl controversy?
We are aware that clients have accused some veterinarians of malpractice in the prescribing of Rimadyl for their dogs. We have, in fact, received E-mail from veterinarians who feel that it was information on the Senior Dogs Project website that caused their clients to so accuse them. Since the side effects information on the srdogs website is, in fact, available in various other forms, including that published by Pfizer, we would like to suggest that it is how the information is used that is the issue and not the presence of the information itself that is at fault.
In one E-mail we received recently, a man told us that his veterinarian laughed at him when he mentioned that he knew Rimadyl had side effects. We don't believe it is in the best interests of veterinarians, their clients, or their clients' dogs to so lightly dismiss a concern expressed by a client. It is a known fact that all drugs have side effects, and, while keeping abreast of all relevant information about them is challenging, we feel it is not appropriate to laugh them off.
|A review of important issues related to Rimadyl: (1) Is Pfizer doing enough to inform and educate veterinarians and the public about the administration and possible side effects of Rimadyl? (2) Are the potential side effects too serious for any situations but those in which there seems to be no safer alternative? (3) Is Pfizer consistent in recognizing when Rimadyl is implicated and in reimbursing for related medical expenses? (5) Is it appropriate for Pfizer to require that "gag" orders (Confidentiality Agreements) be signed in exchange for payment of medical expenses to people whose dogs have taken Rimadyl and had adverse drug experiences?|