• Disclaimer: Hello Guest, Doberman Chat Forums presents the opinions and material on these pages as a service to its membership and to the general public but does not endorse those materials, nor does it guarantee the accuracy of any opinions or information contained therein. The opinions expressed in the materials are strictly the opinion of the writer and do not represent the opinion of, nor are they endorsed by, Doberman Chat Forums. Health and medical articles are intended as an aid to those seeking health information and are not intended to replace the informed opinion of a qualified Veterinarian.”

Cytopoint Or Apoquel for a Dog’s Itchy Skin? Comparing the two!

strykerdobe

Hot Topics Subscriber
mail

By W. Jean Dodds, DVM on January 27, 2019
Cytopoint-for-Itchy-Skin.jpg


Several readers asked us about Cytopoint, a newer medication to relieve itchy skin in dogs, and how it is different than Apoquel after an article we recently penned about the latter.

What is the difference between Cytopoint and Apoquel?
Apoquel (oclacitinib) is a synthetic medication that modulates two (JAK1 and JAK3) out the four known Janus Kinase (JAK) enzymes. JAKs are important in white and red blood cell formation, immunity, inflammation, and also act as sentinels in the body to potentially help protect against tumor formation.

Once the JAKs are inhibited, inflammatory cytokines – that result in inflammation and itching – are slowed or stopped. The cytokines affected are interleukin-2 (IL-2), IL-4, IL-6, and IL-13 for allergy and inflammation. Another cytokine, IL-31, is also affected, but it is the one associated with itchy skin (pruritis).

However, Apoquel affects several important body functions as well as to simply stop itchy skin.

Used for the long-term, Apoquel can lead to a decrease in white blood cells and elevated liver values. Additionally, it increases a dog’s susceptibility to infection and neoplasms, which are new and abnormal growths of tissue in some part of a body that are characteristic of cancers such as mast cell tumors or even adenocarcinoma.

Cytopoint, by contrast, is a very appropriate name for this newer medication. Cytopoint is a protein (monoclonal antibody) and directly binds to the cytokine, IL-31, which is the one associated with chronic itching.

Long-term studies have not yet been published regarding Cytopoint, but very few side effects have been reported in clinical cases. Generally, fatigue has been noted within the first 24-48 hours after injection.

A researcher noted that a few cases showed diminished response with each additional injection, suggesting that antibodies to Cytopoint were developing (a process called tachypylaxis = rapid and short-term onset of drug tolerance).

So instead of affecting many different parts of the body like Apoquel, Cytopoint gets to the point: targeting the exact cytokine that causes the itchy skin.

Are Cytopoint and Apoquel given differently?
Apoquel is an oral and daily medication. However, the manufacturer states that a dog caregiver can give Apoquel for short periods of time and that itch relief should occur within 4 hours.

Cytopoint is an injection given every four to eight weeks by a veterinarian. The manufacturer (same one for both drugs) says that some dogs may need year-round continuous treatment, whereas other dogs may only need it when itchiness flares.

Any other options?
Another option is allergen-specific immunotherapy, although this author has had limited success with it. It functions by gradually increasing the given dosage amount of the specific antigen(s) causing the problem until the tolerance threshold has been achieved. Immunotherapy for environmental antigens can be administered via injectable shots (Allergen-Specific Immunotherapy; ASIT) or a newer treatment option that puts a few drops under the tongue (Sublingual Immunotherapy; SLIT). ASIT and SLIT are specifically tailored to the individual pet.

If the treatment is successful, veterinarians might be able to extend the interval between administrations or cease treatments altogether, but this therapy has an uneven success rate. The success rate for ASIT to alleviate symptoms is stated to be approximately 60-80% and SLIT has been around 60%.

Side effects are noted to be uncommon but they can include injection-site reactions and the rare potential for anaphylactic shock. Thus, we should use caution when prescribing this protocol for environmental allergies.

Preference?
Dr. Dodds and Hemopet Holistic Care clinic use Cytopoint for chronic atopic dermatitis in severe cases, but only after certain steps are taken first.

1. Figure out what is causing your companion dog’s itchy skin
Jumping into immediate itch relief – without knowing the exact cause or causes of the itch – may quell a problem, but doesn’t address the underlying cause which needs to be eliminated. On top of that, it can be costly.

So, first, proper testing needs to be completed.

Itchy skin is often caused by a food sensitivity or intolerance. So, it is preferred to eliminate any documented reactive food proteins from your companion dog’s diet. For this, we suggest NutriScan Food Sensitivity and Intolerance Test for Dogs. NutriScan testing is recommended every 18 months, starting around puberty. Food reactivities can change and are cumulative as pets age.

At the same time, you should also have a serum-based blood test completed for seasonal and environmental allergens such as grasses, weeds, trees, wool, cotton, pollen, mold, fungi, dust mites, fleas, etc. Hemopet also offers this testing.

After NutriScan testing, many dog parents realize that they must carefully read all ingredient labels to be sure that the product is appropriate to feed. They remark that they are happy to have their dogs no longer itching, but also admit that sometimes finding the right foods can frustrating. Hemopet offers an inexpensive consultation to review the results and suggest suitable food options.

Regardless, it is easier to eliminate one or more reactive foods than environmental allergens. Exposure to environmental allergens can be minimized. For instance, if your dog has a reaction to grass, you can wipe off his paws after a walk or have him wear booties. However, if these preventative measures do not work to minimize the reaction, talk to your veterinarian about Cytopoint.

References

Canine Atopic Dermatitis Immunotherapeutic Injection, CADI Injection. Zoetis US, Canine Atopic Dermatitis Immunotherapeutic Injection, CADI Injection | Zoetis US..

Cosgrove, Sallie B., et al. “Long-Term Compassionate Use of Oclacitinib in Dogs with Atopic and Allergic Skin Disease: Safety, Efficacy and Quality of Life.” Veterinary Dermatology, vol. 26, no. 3, 2015, doi:10.1111/vde.12194, https://onlinelibrary.wiley.com/doi/full/10.1111/vde.12194.

Gonzales, A J et al. “Oclacitinib (APOQUEL(®)) is a novel Janus kinase inhibitor with activity against cytokines involved in allergy” Journal of veterinary pharmacology and therapeutics vol. 37, no. 4, 2014, 317-24, Oclacitinib (APOQUEL®) is a novel Janus kinase inhibitor with activity against cytokines involved in allergy.

Pieper, Jason. “Atopic Dermatitis: Steroids vs. Atopica vs. Apoquel vs. Cytopoint.” University of Illinois College of Veterinary Medicine, 18 Jan. 2017, http://www.vetmed.illinois.edu/steroids-vs-atopica-vs-apoquel-vs-cytopoint/.
 
9 Safe Apoquel Alternatives

9 Safe Apoquel Alternatives
Apoquel-FB-2.jpeg


By: Deva Khalsa VMD -

Reading Time: 14 minutes

Allergies in dogs have truly reached epidemic proportions. Most veterinarians keep over-vaccinating dogs (read on to find out why this is a problem) … and conventional allergy treatments only work to suppress the natural functioning of the immune system.

Because of this, the genetic tendency for allergies appears to be increasing. Generation after generation it gets worse for our dogs. Allergies have become so much worse; even some of the drugs that used to help, like steroids, don’t work well any more. We’ll talk more about steroids later.

What is that over-vaccination and the suppression of the immune system going to do in the future? The epidemic of allergies we see right now is due to these factors, and the situation is only getting worse. It’s high time that we make a brave attempt to alter this course of events.

We need some Apoquel® alternatives. And luckily, I’ve got them. But first…

Is It Really An Allergy?
An allergy is due to a misbehaving immune system. The immune system is reacting to something it shouldn’t be reacting to. Think of a person with peanut allergies. All his friends may be eating all kinds of peanut candies and peanut butter sandwiches, but he can’t touch them. Is the problem the peanuts or the immune system? That’s right, it’s the immune system. So how do conventional treatments handle this misbehaving immune system? By abolishing it. No matter what drug I mention below, it’s an immune system extinguisher.

Interestingly, food sensitivities and intolerances are actually 15 times more prevalent than bona-fide allergies. In fact, reactions to food lie at the base of the pyramid in the whole scheme of allergies. The environmental factors act as the straw that break the camel’s back.

Throwing A Wrench In The Works
Here’s the rub, as far as food sensitivities and intolerances go. The reaction takes from a week to a month to manifest itself. So you can feed your dog, let’s say lamb, and get no response between days 1 to 14 of feeding it. So you assume that lamb is just fine. When you finally do get a response on day 21, you have no idea what actually caused it.

The standard allergy tests that most vets use to find out what your dog is allergic to are only 15% accurate for foods. What that really means is that these tests are 85% inaccurate and you can’t trust them at all as far as foods go. The good news is that these tests are 85% accurate for environmental allergens. Yet if foods are the base of the allergic response, we really have to find out what foods are the culprits.

Testing For Allergies At Home
The NutriScan food sensitivity test is a saliva test done by Hemopet. You can visit the website and send the sample in yourself. It’s a reliable test for food sensitivities and intolerances. (Remember, this is what’s really happening.) The thing is, you may find your dog is allergic to an amazing number of foods and be at a loss about what to feed.

I recommend you repeat the test every 6 months as the foods your pet reacts to will change with time.

Find three different meals that agree with your dog and rotate on a three-day basis. This will prevent him from developing an allergy to the food.

There’s another problem with finding out exactly what’s causing the allergies. Foods have compounds in them called phenolics. Phenolics create the taste and smell in foods and other substances. They’re in vegetables, fruits, meats, poultry, fish and potatoes. One particularly notorious phenolic is named gallic acid and it’s in 70% of foods. The issue: tests don’t check for phenolic sensitivity.

Often owners of dogs with “allergies” finally find a food that agrees with their best friend. Joyfully, we run and put Fido on the food and feed it every day. Why not? He loves it and either the itching or diarrhea or both are handled when he is eating it. Here’s the problem. Feeding the same food day after day will almost guarantee that an immune reaction will develop.

Here’s a perfect example: vets snap on talc-powdered latex examination gloves many times a day. As time passes we become allergic to the talc. Give it a little more time and we become allergic to the latex. Folks who never use examination gloves will not get this allergy.

That’s why the best way to go is to find three different meals that agree with your dog and rotate on a three-day basis. This will prevent him from developing an allergy to the food.

A Little History Of Conventional Allergy Drugs

It used to be that steroids, such as prednisone, were dispensed too excessively. Veterinarians had little choice about what to use for dogs with allergies. Steroids worked because they suppressed the immune system so well. But, dogs would wind up drinking and urinating too much and losing their fur when taking these steroids. That’s why dogs were weaned off as soon as they were comfortable again. Of course the fix was only temporary. Within weeks or months most doggies would have to go back on another round of steroids. Lots of dogs had seasonal allergies so they would go on prednisone in, let’s say, just the spring and fall seasons. At least they were only on these immune-suppressing drugs for short stints.

Feeding the same food day after day will almost guarantee that an immune reaction will start.

But then, steroids like prednisone and dexamethasone simply stopped working well. Dogs would take it and it did little for the itch.

Just about this time, a drug called Atopica (cyclosporine) became available. Some veterinarians began using Atopica instead of steroids. Yet, the side effects of Atopica were considerably worse.

drug-cyclosporine-1.jpg

Cyclosporine was developed in Switzerland in the 70s. It was designed to prevent the rejection of organs in transplant patients. In order to do this, it had to knock the immune system to smithereens. Dogs were getting cancer (one of the many side effects of cyclosporine) because they were on this drug.

That’s why, when Apoquel came onto the market, it seemed to be a dream come true. There was no excessive drinking as with steroids. There were no apparent serious side effects as with cyclosporine. Dogs simply stopped itching and were, once again, comfortable in their own skin. Veterinarians loved it, as it worked well in just about every case. The dogs loved it because they stopped itching. Pharmaceutical companies and vets loved it because people had to buy it and refill it each month … for the dog’s entire life.

Dogs weren’t taking it for some short period in the spring or fall when they had their allergies. Once they started Apoquel, the dog would seem to need it forever. Once again, Apoquel doesn’t cure, but merely suppresses the allergic symptoms.

Apoquel works because it slays the kinases, which serve as the communicators in the body.

Unlike steroids, it’s very difficult to get dogs off Apoquel. When I treat a dog to eliminate her allergies, I reprogram her immune system. I occasionally have to put the patient on prednisone for a very short period. This is because the capacity for internal communication in the body is compromised. Apoquel destroys the communication system. There has to be an immune system in place in order to correct it.

How Does Apoquel Work?
Exactly how is Apoquel getting the immune suppression job done?

Apoquel works because it slays the kinases, which serve as the communicators in the body. Kinases coordinate absolutely everything in the body with one communicating to the other. Think of it just like a big happy Italian family. Kinases never stop communicating. One talks to another and that one talks to 100 more kinases and the body’s functions get organized.

Kinases are the repair and regeneration mechanism of the body. They are the communicators and communicate between cells.

They have enormous diversity. They play a critical role in cellular communication and signaling.

Kinases send signals and perform regulatory complex processes in cells.

Dogs who get Apoquel become dependent on it. Allergies are often even more severe when the owner tries to wean their dog off it.

Kinases actually activate stem cells. Stem cells are our dogs’ internal repair system. They divide essentially without limit to replenish other cells. Each new cell either remains a stem cell or becomes another type of cell with a specialized function. These could be muscle cells, red blood cells or brain cells.

Kinsases are used extensively to transmit signals and control complex processes in cells. Up to 518 different kinases have been identified in humans.

Mutations in kinases that lead to a loss-of-function can cause cancer and disease.

The bottom line is that APOQUEL stops important kinases from functioning in your pet’s body. Apoquel obliterates several very important kinases to knock the immune system to smithereens.

And this particular allergy fix is addictive. Dogs who get Apoquel become dependent on it. Allergies are often even more severe when the owner tries to wean their dog off it. It’s a winning situation for the pharmaceutical companies as they get to sell this drug for a dog’s lifetime …

… until they develop cancer. One of the kinases Apoquel snuffs out is the one that searches for cancer cells.

Note: The drug Cytopoint was developed because it neutralizes only one kinase. That said, the communication between kinases is interdependent on many different kinases communicating. So the safety of Cytopoint remains in question.

Preventing Allergies In The Future
When there were fewer vets on the planet, vaccines were given to puppies and not repeated on a yearly basis. Vets had plenty of business and didn’t need to send out annual reminder cards. These old-fashioned vets were doing it right. One puppy shot for distemper and parvovirus after 18 weeks is GOOD FOR LIFE.

Of course now your vet will probably try to convince you to pay out for other vaccines. Leptospirosis, Lyme, kennel cough and canine flu vaccines – this list goes on. Just don’t buy into the hype. The first three are bacteria. Vaccines against bacteria have to be given at least 2 to 3 times a year to be effective. And the kennel cough vaccine? It doesn’t even prevent the disease: it simply lessens the severity.

The thing is, these unnecessary vaccinations and the suppressive treatments have an effect. Dogs with allergies are being treated with drugs that suppress the immune system … drugs that screw up the inter-body communication. What kind of offspring will these dogs give birth to?

Dogs have 10 times more mast cells on their skin than people do. If we were built like a dog, we’d be itching our behinds and inner thighs during ragweed season.

How many allergic dogs will we have in the next 10 years? Will the percentage double? I personally think it will go up, not twice, but at least 10 times.

So what’s the first thing I want you to know about allergies? You shouldn’t, and I cannot stress this enough, over-vaccinate. Minimize toxins and minimize vaccines. I’ve specialized in treating dogs with allergies for 40 years. And I create a non-allergic dog using natural methods. But I’ve seen allergies return right after dogs are vaccinated again. Dog gets better. Dog isn’t itching for years. Dog gets vaccinated and it all starts up again.

Preparation For Dogs On Apoquel
As Benjamin Franklin said, “An ounce of prevention is worth a pound of cure.” This certainly applies to doggy allergies.

If you’re reading this blog, your dog may be on Apoquel already. I’ve got to warn you about what happens when you stop the Apoquel. Oftentimes, the itching that established the need for Apoquel will now be much worse. With steroids (prednisone), you’d just stop them and then it would take a while for the itching to come back.

It’s not so with Apoquel. The itching often comes back with a vengeance. I suggest that you have a natural substance at the ready (you’ll find these below). Don’t stop and wait to see what happens. You will, most likely, need something within a day or so of stopping the drug.

Allergies Can Be Complicated By Other Issues
Allergies do not, only or always, exist as an island in themselves.

Other problems can occur, either alone or in addition to allergies. And these problems can cause itching.

Something like sarcoptic mange (scabies) can look just like allergies. This is particularly true if the owner is doting and cares very well for the dog. In veterinary school, we’re taught the classical picture of scabies is a dog with crusts on the edges of his ears. I can say, with certainty, that I almost never see a case of scabies that looks like that. What I see are dogs who stop and itch when they’re doing something interesting. Sometimes the owners can have red bumps, particularly if they sleep with a dog who has it. It’s hard to diagnose with routine skin scrapings as the mite lives really deep in the skin. The best way to know if your dog has scabies is to treat it with Ivermectin. After the second dose (not the first) the itching will dramatically decrease. If your breed cannot tolerate Ivermectin you can use Revolution to treat it.

Dogs with allergies are being treated with drugs that suppress the immune system … drugs that screw up the inter-body communication.


Another complication is malasezzia. Malassezia is a yeast that normally lives on a dog’s skin and when it overgrows – boy is it itchy! I cannot stress this enough. Some dogs just have the yeast and treating it with an enzyme shampoo will help. But dogs with allergies tend to get inflamed skin and so the yeast has a super opportunity to overgrow. The itching of the allergy and of the yeast both combine to create a very, very itchy dog.

There’s still more. Dogs with allergies can often get a secondary bacterial infection, so you have to watch for that. A secondary bacterial infection is not uncommon in dogs on Apoquel. Demodex infections – a mite that grows in immune compromised dogs – also occurs.

In some cases, you’re treating for a myriad of problems at once. Allergies, insensitivities, intolerances, malasezzia yeast and secondary bacterial infection can all be common.

What can we do for dogs with allergies? Are there any alternatives to Apoquel? The answer to that question is a resounding yes.

Apoquel Alternatives
There are important Apoquel alternatives out there. I always prefer an allergy elimination therapy. Who wants to give natural itch relieving products, change dog food constantly, or read labels with a magnifying glass? You can change foods till the cows come home but you can’t avoid every blade of grass and every pollen or mold. Allergy elimination therapy is a simpler solution.

Apoquel-Info.jpeg


Stuff to do to avoid the allergic reactions:

  1. Feed a rotating diet. Use a novel protein, which is a protein that your dog has never had before. Use novel ingredients.
  2. Try feeding rabbit based food as rabbit has one rare phenolic and contains no gallic acid.
  3. Get an air purifier for your home.
  4. Nip the itch in the bud with a topical product that works to calm the area in which it starts.
  5. Test Vitamin D3 levels. 75% of dogs fed commercial food are D3 deficient. Vitamin D levels have found to be very important when it comes to allergies.
Here are some things you can use help the itch.

Remember – many allergic dogs are allergic seasonally. You can give these products during the common allergy seasons in dogs, the spring and fall. Another important point is that it’s difficult to get dogs off of Apoquel, so you need something on hand.

Chinese Herbs: Zhu Dan Tablets from Seven Forests can help with the itch. Give:

  • ½ pill to 1 pill twice a day for a smaller dog
  • 1 pill two to three times a day for a medium dog
  • 2 pills two or three times a day for a large dog
I recommend giving these with a meal.
Histoplex by Biotics Research. Give:

  • A small dog can get ½ pill twice a day
  • Medium dog 1 pill twice a day
  • A large dog can have up to 3 pills twice a day while 2 pills twice a day usually suffices.
Betathyme – a naturally formed steroid that can help to stop that itch. Follow the directions on the label.

Atronex by Standard Process – is a very nice product that helps to curb the itch. Like Betathyme, follow the directions on the label.
Apoquel-02-Info.jpeg


Topical Solutions
Dogs have ten times more mast cells on their skin than people do. If we were built like a dog, we’d be itching our behinds and inner thighs during ragweed season. And, just like with people, your dog’s itching makes things worse. Itching increases the intensity of the itching because it activates more mast cells. When your mother told you that the more you itched that mosquito bite, the more it would itch, she was spot on!

What I’m trying to say with all this is that if you can nip the first itchy spot in the bud, you’re way ahead of the game. Itching begets itching and if we can handle the first set of itches we may be able to win the battle.

  • Derma Drops by Spa Diggety Dog – get these on the spot fast
  • Zymox spray on or crème formula for hotspots
  • Baking Soda – make a poultice and slurry it on the area
  • NuStock – a dependable product to nip itching in the bud
Allergy Elimination

While topical solutions win the battle, allergy elimination wins the war. That’s because it can correct the immune system’s perception of the item as an allergen. This turns the allergic dog into the non-allergic dog.

Allergy Elimination techniques began with Nambudripad’s Allergy Elimination Technique (NAET). Forty years of experience taught me that pet owners may easily do a similar program in the comfort of their own home.

My years of experience have allowed me to untangle and decode the basic items that pets need to be treated for. Allergy elimination techniques will naturally reboot, harmonize and revitalize your pet’s inappropriate immune system responses. It corrects the immune system so it behaves correctly and doesn’t overreact.

Some pets will need a direct consultation to assess and go over long term skin problems. For dogs with a less complicated history, they can often be helped with an at home kit.

For dogs with allergies and the owners watching them itch, Apoquel looked like a miracle. Unfortunately, it turned out to be anything but. The negative effects of this drug (as well as the others used to treat allergies) are now well known. Thankfully these Apoquel alternatives are things you can try to mitigate the risks and keep your dog safe and allergy free.

Deva Khalsa VMD

Since beginning her holistically oriented veterinary practice over 25 years ago, Dr Deva Khalsa has been incorporating homeopathy, acupuncture, Chinese herbs and nutritional advice into her practice. She also offers her unique Allergy Elimination 4 Pet technique to naturally reboot your pet's inappropriate immune system responses. She's the author of Dr Khalsa's Natural Dog, now in its second edition. Visit her online at doctordeva.com
 
Please give second and third thoughts before giving this drug to your pets!
Please give second and third thoughts before deciding to give this med (Apoquel) to your pets! Maybe Vets should look for causes of allergies instead of just suppressing the symptoms?


Update
A letter the FDA sent to Zoetis the manufacturer of Apoquel.

https://www.fda.gov/media/113909/download


Dawn M. Cleaver, DVM Associate Director, Regulatory Affairs Zoetis, Inc. 333 Portage Street Kalamazoo, MI 49007
RE: NADA 141-345 APOQUEL® (oclacitinib tablet)
Dear Dr. Cleaver,
The U.S. Food and Drug Administration (FDA), Center for Veterinary Medicine (CVM), Division of Surveillance has reviewed the website for APOQUEL (oclacitinib tablet), APOQUEL: Atopic Dermatitis Oclacitinib Tablet Treatment for Dogs | Zoetis US. This website makes false or misleading representations about the risks associated with APOQUEL. The website therefore misbrands APOQUEL within the meaning of the Federal Food, Drug, and Cosmetic Act (FD&C Act), and makes its distribution violative. 21 U.S.C. 352(a), (n); 321(n); 331(a).
Background
Below are the indication and summary of the most serious and most common risks associated with the use of APOQUEL.

According to the FDA-approved package insert (PI), APOQUEL is indicated for the control of pruritus associated with allergic dermatitis and control of atopic dermatitis in dogs at least 12 months of age.
The PI contains warnings and precautions including the following: (1) should not be used in dogs with serious infections; (2) may increase susceptibility to infection, including demodicosis, and exacerbate neoplastic conditions; (3) is not for use in breeding dogs, or pregnant or lactating bitches; (4) has not been evaluated in combination with glucocorticoids, cyclosporine, or other systemic immunosuppressive agents; and (5) dogs receiving APOQUEL should be monitored for the development of infections, including demodicosis, and neoplasia.

2

False or Misleading Risk Presentation
Promotional materials misbrand a drug if they are false or misleading with respect to risk or benefits. The determination of whether promotional materials are misleading includes, among other things, not only representations made or suggested in promotional materials, but also failure to reveal facts material in light of the representations made or with respect to consequences that may result from the use of the drug as recommended or suggested in the materials.

The opening page on the APOQUEL website contains the following statements, with a link on the word “Safe:”

Safe: • Without many of the side effects associated with steroids • Can be used with many other drugs, including anti-infectives, parasiticides, antifungals, NSAIDs and allergen-specific immunotherapy

When clicking on “Safe”, another page opens that contains additional positive information regarding safety:

• Minimal side effects - Side effects of APOQUEL were similar to placebo without many of the side effects associated with the use of steroids • Can be used concomitantly with many other medications - APOQUEL can be used with many common therapies including vaccines, NSAIDs, antibiotics and allergen-specific immunotherapy
These claims misleadingly suggest that APOQUEL is safer than steroids without providing comparative studies to support the claim. Moreover, they misleadingly minimize the risk associated with the use of APOQUEL by citing a short term study to support the claim that the side effects are minimal and were similar to placebo when a higher frequency of adverse reactions in Apoquel treated dogs was seen in a longerterm study.
The website cites a short-term study1 (Cosgrove, 2013) to substantiate claims that the product is “safe,” and that the “side effects were similar to placebo without many of the side effects associated with the use of steroids.” The website also cites a long-term study2 (Cosgrove, 2015) to substantiate claims that the product is “safe for long-term use” and that APOQUEL “can be used concomitantly with many other medications.” The Cosgrove 2015 reference contains the following statement regarding risks identified in this study: “The abnormal clinical signs reported most frequently (in ≥5% of the dogs) as a non-pre-existing finding were as follows: urinary tract infection/cystitis (11.3%),
1 Cosgrove SB, Wren JA, Cleaver DM, et al. Efficacy and safety of oclacitinib for the control of pruritus and associated skin lesions in dogs with canine allergic dermatitis. Vet Dermatol. 2013;24(5):479-e114. doi:10.1111/vde.12047. 2 Cosgrove SB, Cleaver DM, King VL, et al. Long-term compassionate use of oclacitinib in dogs with atopic and allergic skin disease: safety, efficacy and quality of life. Vet Dermatol. 2015;26(3):171-179. doi:10.1111/vde.12194.


3

vomiting (10.1%), otitis (9.3%), pyoderma (9.3%) and diarrhea (6.1%).” These findings contradict the reported findings of the Cosgrove 2013 study that the side effects of APOQUEL are similar to placebo. In addition, several of these findings are consistent with the Warnings statement “APOQUEL may increase susceptibility to infection…” contained in the FDA-approved product labeling.
In addition, these claims misleadingly suggest that APOQUEL can be safely used concomitantly with other products, but omit the following important information found on the approved labeling: “The use of APOQUEL has not been evaluated in combination with other systemic immunosuppressive agents.”

We acknowledge that the opening page on the APOQUEL website includes the following safety information:

• Important Safety Information Do not use APOQUEL in dogs less than 12 months of age or those with serious infections. APOQUEL may increase the chances of developing serious infections, and may cause existing parasitic skin infestations or preexisting cancers to get worse. APOQUEL has not been tested in dogs receiving some medications including some commonly used to treat skin conditions such as corticosteroids and cyclosporine. Do not use in breeding, pregnant, or lactating dogs. Most common side effects are vomiting and diarrhea. APOQUEL has been used safely with many common medications including parasiticides, antibiotics and vaccines.
However, the website’s representation of APOQUEL as having “minimal side effects,” as being “similar to placebo without many of the side effects associated with the use of steroids,” and as “safe for use with many other drugs, including…allergen-specific immunotherapy” contradicts the important safety information and the risks associated with the use of APOQUEL. Conclusion and Requested Action
For the reasons discussed above, the website misbrands APOQUEL within the meaning of the FD&C Act, and make its distribution violative. 21 U.S.C. 352(a), (n); 321(n); 331(a).

CVM requests that Zoetis, Inc. immediately cease the dissemination of the APOQUEL promotional items described above and any other materials that fail to accurately represent the risks associated with the use of APOQUEL.

Please submit a written response within thirty calendar days of receipt of this letter describing whether you intend to comply with this request, listing all promotional materials (with the Form FDA 2301 submission date) for APOQUEL that contain presentations such as those described above, and explaining your plan for discontinuing use of such materials, or, in the alternative, for ceasing distribution of

4

APOQUEL. Please direct your response to Dr. Neal Bataller at the Food and Drug Administration, Center for Veterinary Medicine, Division of Surveillance, HFV-210, 7519 Standish Place, Rockville, Maryland 20855.

The violations discussed in this letter do not necessarily constitute an exhaustive list. It is your responsibility to ensure that the promotional materials for APOQUEL, as well as other Zoetis, Inc. products, comply with the requirements of the FD&C Act and applicable FDA regulations.

If you have any questions, please contact Dr. Dorothy McAdams at the address above, or by phone at (240) 402-5763.

Sincerely,



_________________________ Neal Bataller, ME, DVM Director, Division of Surveillance Office of Surveillance and Compliance Center for Veterinary Medi
 
By Dr. Judy Morgan
Shocking Drug Statistic

Shocking Drug Statistic
by Judy Morgan February 17, 2020
I recently read in the AVMA journal that Apoquel has become the top-selling product in the U.S. animal health industry, according to data from the Executive Animal Health Study Center based in Belgium. It has surpassed the flea and tick preventives at different points during the last couple of years, the first time that a therapeutic agent has surpassed the flea and tick preventives that had dominated forever.

I have been outspoken against the use of chemical flea and tick prevention products, as well as the use of immunosuppressive drugs such as Apoquel and steroids for many years. The reason these drugs are so popular is very clear once we realize the top reasons dogs and cats are presented to veterinarians for treatment are itching, ear infections, allergies, and skin disorders.

Side effects listed when using Apoquel include vomiting, diarrhea, lethargy, anorexia, increased thirst, and overwhelming bacterial and fungal infections, including pneumonia. From the package insert, we see approximately 6% of test dogs developed cancers:

After completing APOQUEL field studies, 239 dogs enrolled in an unmasked (no placebo control), continuation therapy study receiving APOQUEL for an unrestricted period of time. Mean time on this study was 372 days (range 1 to 610 days). Of these 239 dogs, one dog developed demodicosis (demodex mange) following 273 days of APOQUEL administration. One dog developed dermal pigmented viral plaques following 266 days of APOQUEL administration. One dog developed a moderately severe bronchopneumonia after 272 days of APOQUEL administration; this infection resolved with antimicrobial treatment and temporary discontinuation of APOQUEL. One dog was euthanized after developing abdominal ascites and pleural effusion of unknown etiology after 450 days of APOQUEL administration. Six dogs were euthanized because of suspected malignant neoplasms: including thoracic metastatic, abdominal metastatic, splenic, frontal sinus, and intracranial neoplasms, and transitional cell carcinoma after 17, 120, 175, 49, 141, and 286 days of APOQUEL administration, respectively. Two dogs each developed a Grade II mast cell tumor after 52 and 91 days of APOQUEL administration, respectively. One dog developed low grade B-cell lymphoma after 392 days of APOQUEL administration. Two dogs each developed an apocrine gland adenocarcinoma (one dermal, one anal sac) after approximately 210 and 320 days of APOQUEL administration, respectively. One dog developed a low grade oral spindle cell sarcoma after 320 days of APOQUEL administration.

Would you knowingly give your family member a drug to decrease itching if cancer was a possible (or probable) side effect? How many of you have used this drug without any warning from your veterinarian? While this drug has only been studied in dogs, it is now being used off-label for cats, as well.

Allergies, skin infections, and ear infections are related to immune system dysfunction, which commonly occurs secondary to gut dysbiosis (imbalance of good and bad bacteria within the bowel resulting in swelling of the cells lining the bowel and secondary leaky gut).

The basis of allergy treatment requires healing of the gut with an appropriate diet, repair of the immune system, and rebalancing bacterial growth within the body. Holistic veterinarians use herbs, diet, acupuncture, and chiropractic care to rebalance and repair the body.
 

Back
Top