HEALTH - FDA Warns of Accidental Overdose in Dogs from Sileo

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The US Food and Drug Administration (FDA) is alerting dog owners and veterinarians about the risk of accidental overdose to dogs treated with the drug Sileo.

Sileo was put on the market May 2016 and is the first drug the FDA has approved for treating noise anxiety in dogs.

Noise anxiety has been challenging to manage with past options for treatment including behaviour modification, anti-anxiety medicine, tranquilizers and gadgets like the ThunderShirt.

Sileo is packaged in an oral dosing syringe with a ring-stop mechanism on the plunger that must be “dialed” and locked into place in order to set the correct dose for the dog.

Overdose can result if the ring-stop is not fully locked, therefore it is very important that the person administering the product understands how to operate the syringe correctly before giving the product to the dog.

The FDA has received 28 reports involving Sileo overdoses in dogs due to the ring-stop mechanism not properly locking at the intended dose.

While no deaths have been reported, in 15 out of the 28 reports, dogs experienced clinical signs of overdose, including lethargy, sedation, sleepiness, slow heart rate, loss of consciousness, shallow or slow breathing, trouble breathing, impaired balance or lack of coordination, low blood pressure, and muscle tremors.

The FDA is warning that all veterinarians and users of the product should be aware of the possibility of accidental overdose and how to use the syringe applicator properly.

Zoetis, the manufacturer of the drug, has provided online resources which demonstrate the proper operation of the syringe and administration technique in detail for veterinarians at Sileodvmus.com, and for dog owners at Sileodogus.com.

HEALTH - Making Animal Testing in Clinical Trials More Ethical

It's long been a conundrum for animal lovers – how do researchers gather data required to improve the plight of those suffering from disease and illness while ensuring no animals suffer to see that objective met.

Well, one American start-up company is touting a new approach to solve that age-old dilemma.

Rather than causing disease in animals, typically mice and monkeys, to do clinical trials before drugs are given to humans, the company is recruiting animals who already have “naturally occurring diseases” which also present in humans, according to an article in MedCityNews.

The One Health Company's approach is to find dogs and cats with a disease, such as bone cancer, and test new drugs or therapies on them.

That means animals won't be put in labs and inflicted with disease but potentially targeted for therapy which may help them recover, while also providing crucial data for drug companies looking to hone products to market to humans.

The goal is “two-fold: Provide pro-bono care for pet owners to heal their own pets, while facilitating bringing new drugs to market by collecting data for pharmaceutical companies,” MedCityNews reported.

Benjamin Lewis, co-founder and chief operating officer of The One Health Company, says,“Nobody talks about animal testing because it’s so taboo. We work the same way as a human clinical trial, except we recruit sick pets instead of sick people.”

The company does contract research and claims to have more than 35 trial sites at veterinary hospitals in the U.S. as well as countries like France, Belgium and Brazil.

One Health, which links trials aimed at giving an animal a better chance at recovery with researchers looking to glean data in clinical trials, says it already has a database of about 450,000 pets which can potentially be matched as candidates to take part in trials.

The company's approach echoes a recent initiative of the American Veterinary Medical Association (AVMA) whose online database is designed to direct vets and pet owners to treatment options and assist researchers in recruiting animals to take part in clinical studies. The AVMA database is available to the public.

Although a real-life anecdote with just one animal – the experience with Lewis' dog, Euro, illustrates the potential for partnerships forged by the company.

Euro, a doberman pinscher with an aggressive bone cancer, was initially given a three-month prognosis but three years later is doing well after participating in an immunotherapy drug trial.

Rather than living in a lab, pets “remain with families, diseases are never induced and putting a pet down in never considered an option in any clinical trials,” MedCityNews reports.

Ideally, what happens is that a sick pet is put into a trial and owners submit data on its behaviour to companies running trials which are all on therapies which have been subject to extensive testing on other animals.

“We collect data on side effects, which are very, very valuable for pharmaceutical companies,” says co-founder and CEO Christina Lopes.

The 2005 mapping of the canine genome which showed dogs mimics humans much more than a lab mouse, for instance, means additional testing (beyond other animals in prior trials) is advantageous.

That means the company's approach is more cost-effective and more relevant to pharmaceutical companies given its trial subjects offer data which is “more predictive in human outcomes.”

The company's focus will be on combination therapies and immunotherapy drugs aimed at using the body's own immune system to defeat cancer or other diseases.

While the company has only been at work for seven months, it is running two live trials, has attracted more than $750,000 and set up contracts with a large pharmaceutical company.

Typically, the Food and Drug Administration requires drugs to be used in human clinical trials to be tested first in animals to evaluate their safety and how they interact with living tissue.

But, according to MedCityNews, “the typical testing method is to take a healthy animal, give them a certain disease, test the drug, therapy, or medical device, and then kill them.”

By Nadia Moharib

Nadia is an animal lover who has adopted everything from birds to hamsters, salamanders, rabbits, fish and felines. She has written about all-things-pets for years and was a long-time editor of a pet magazine in a daily newspaper which featured a Q & A column, Ask Whit, penned by her pooch (ghost written, of course.) The serial dog owner lives in Calgary, Alberta and most days can be found at a dog park picking up after her rescue pooch, Scoots.

RESEARCH - 'Natural' 'Humane' Food Labels Create Confusion

A recent survey by Lake Research Partners shows that even though 77% of American consumers are concerned about the welfare of farm animals, there is significant confusion about how to make ethical purchases and what existing labelling means.

28% of consumers who are not paying attention to labels relating to welfare standards just don’t know what to look for. And even among those consumers who are paying attention, confusion about what the labels mean is a big problem.

For example, “free range” does not mean that the labeled product comes from an animal that spent most, or even much, of its time in a pasture.

There is no legal definition of “free range” for pork, beef, or dairy, and while there is a legal definition for poultry, it is far from what the label seems to indicate. In order to be labeled “free range,” it is only necessary for the birds to have had access to the outdoors, regardless of the size of that space, or how long they were allowed out.

Similarly, “humane” has no legal definition and producers can use it regardless of their farming practices, and “natural” only refers to how the meat is handled after slaughter.

This is a big problem both for consumers who want to support humane farming practices, and for producers who are holding themselves to higher standards.

75% of consumers in the survey also said they want independent inspectors and qualified third parties to ensure that the labels on products mean what they seem to imply.

This is an important take-away for stores and brands, and one way that producers who are aiming for higher standards can ensure that consumers are able to find and trust their products.

The Food and Drug Administration (FDA) defines ‘natural’ as “nothing artificial or synthetic,” such as color additives, has been added to a food that would not normally be expected to contain it. But that definition is over two decades old.

With a variety of class action suits accusing companies of misleading consumers by labeling foods containing artificial, synthetic or genetically modified ingredients as “all natural,” petitions from citizens and a number of federal court judges have called upon the FDA to update their definition.

As a result, the FDA collected comments on the use of this term in the labeling of human food products and are currently compiling the data.

Some certifications are currently available, such as the Animal Welfare Approved (AWA), Certified Humane (CH), or Global Animal Partnership (GAP) certifications. These organizations do provide the kind of independent inspection that consumers are starting to demand.

The Canadian Federation of Humane Societies has adopted the “Five Freedoms,” a concept originating in, and still used by, the UK government. But despite this, and the research that supports standards based on the Five Freedoms, there is still a lack of comprehensive, independent oversight in any of these jurisdictions.

As one way to address this issue the American SPCA has launched Shop With Your Heart, a resource guide that hopes to help consumers learn about farm animal welfare, understand existing labeling, find products that have a higher welfare standard, and even resources to help consumers request that supermarkets carry a wider variety of welfare-certified products.

By Tiffany Sostar

Tiffany is a writer, editor, academic, and animal lover who came late to her appreciation of pets. At 18, a rescue pup named Tasha saved her from a depression and she hasn't looked back. She has worked as the canine behaviour program coordinator for the Calgary Humane Society, and was a dog trainer specializing in working with fearful and reactive dogs for many years. She doesn't have any pets right now, but makes up for it by giving her petsitting clients (and any dogs she comes across on her frequent coffee shop adventures) extra snuggles.

HEALTH - New Medication for Dogs with Noise Anxiety

It’s a common sight - Fido panting, trembling or running for cover when he hears loud noises like thunder or fireworks.

Noise aversion or anxiety has been treated with anti-anxiety medicine, tranquilizers and behaviour modification with mixed results.

Now pet owners have a new option - a gel medication that can be safely administered at home to help calm dogs without sedation. This allows dogs with noise aversion to remain calm yet fully functional.

Manufactured by Zoetis, SILEO is a gel formulation of dexmedetomidine, a highly selective alpha-2 adrenoceptor agonist that blocks norepinephrine release, a chemical in the brain that is involved with the development of fear and anxiety.

“We know that noise aversion has been difficult to treat, is stressful for pet owners and can be traumatic for their dogs. SILEO works the way veterinarians and pet owners need it to work, calming dogs while allowing them to interact normally with the family,” said Shelley L. Stanford, DVM, MS, MBA, group director, Companion Animal Veterinary Professional Services at Zoetis.

“It has rapid speed of onset, is easy to administer at home and works ‘in the moment,’ without any other treatments or training.”

SIELO is the first and only medication approved by the U.S. Food and Drug Administration (FDA) for treatment of noise aversion in dogs.

Each dose lasts two to three hours and takes effect within 30-60 minutes after application.

The first dose can be given as soon as the dog shows signs of anxiety and fear, or approximately 30–60 minutes before a known anxiety- or fear-causing noise stimulus, such as fireworks.

FDA Approves New Drug for Canine Osteoarthritis

As dogs live longer lives there has been an increase in incidence of painful chronic conditions like osteoarthritis. Pain killing drugs are almost always part of the treatment for this condition, if not at the beginning then as it progresses.

The U.S. Food and Drug Administration (FDA) recently approved Galliprant (grapiprant tablets) for pain management in dogs.

While there are other non steroidal anti-inflammatory drugs on the market like meloxicam and deracoxib, Aratana Therapeutics, who developed the drug, state that “Galliprant is a first-in-class non-cyclooxygenase (COX) inhibiting, non-steroidal anti-inflammatory drug (NSAID) in the piprant class.”

Piprants are a newly recognized drug class.

Aratana goes on to say that, “using a new mechanism of action, this therapeutic directly blocks one of the key receptors involved in pain and inflammation — the EP4 prostaglandin receptor.”

Aratana hopes to market it based on data showing both effectiveness and a lack of dangerous side effects like gastrointestinal bleeding.

CEO Steven St. Peter is confident Aratana's new drug will be able to grab significant market share. "As the first approved product in the new piprant class, Galliprant offers veterinarians a needed therapeutic option for the millions of dogs treated each year for osteoarthritis," St. Peter said in the press release announcing the FDA approval.

Osteoarthritis, also known as degenerative joint disease (DJD), is defined as the progressive and permanent long-term deterioration of the cartilage surrounding the joints. Arthritis is the medical term for inflammation of the joints.

Will Pet Food Labels Be Changing?

Animal groups want to see stricter ingredient standards and labels on pet food. Kathy Guillermo, Senior Vice President at People for the Ethical Treatment of Animals (PETA) said, “Pet food should be prohibited from having ingredients taken from 4D bins. This is the term that refers to where they place the bodies of animals that are dead, dying, and diseased.” According to Guillermo, animal tissues that are not for human consumption are placed in 4D bins.

PETA also wants the Food and Drug Administration (FDA) to force manufacturers to issues product recalls if a product has caused illness or death in animals. Currently the FDA can request or order that a product is removed from the market. The FDA is updating their regulations by September 2015 due to a legislation from 2007 requiring updated nutritional and ingredient information. Guillermo said, “We know the wheels of the government turn very slowly and when animals are involved even slower, but it’s unfortunate it has taken since 2007 to get this rolling. I think it has been mostly left to the industry to decide what is adequate and what is proper and that’s why this is a good idea to have a federal regulation to make sure it’s consistent across the board.”

Pet food producers are concerned that the new regulations will be too similar to the nutritional information required for human food. The Pet Food Institute (PFI) represents 98% of dog and cat food manufacturers in the United States. PFI supports FDA labeling standards provided the standards are not modeled after human food labels. President and CEO of PFI, Cathleen Enright said, “Currently if you look on packages for human food there’s a serving size, but that doesn’t translate when you are talking about a dog.” Human food also requires the protein/fat/vitamin contents be listed as a percentage of daily requirements whereas pet food labels require maximum and minimum percentages. There is concern that if pet food labels are too similar to human food labels consumers will become confused because people and pets have different nutritional requirements. 

Chair of the Association of American Feed Control Officials (AAFCO) Pet Food Committee, Stan Cook believes that national labeling regulations could be positive (pet food regulations are currently decided by each State). Cook also said, “Some consumers want pet food labels to more closely resemble human food labels. Many in the regulatory arena are concerned that making the labels appear the same as a human food label is a food safety issue.”

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