Danger? Why some medications may be making your pet sick

PHOENIX - Some popular pet medication may be causing side effects such as seizures, tremors – even death.

It's a story you've been commenting about for days here on ABC15.com, and now there's new reaction from the Environmental Protection Agency.

The medication is meant to protect, but the ABC15 Investigators found many pet owners complaining about dangerous reactions they say were caused by some flea and tick products.

Amy Vasquez of Chandler said her dog, Mack, had a bad reaction to a medication.

“He would reach around and bite at himself,” Amy said. “He was scratching himself, and wouldn't stop it.”

Normally those are signs of either flea or tick bites. But Amy said it was caused by a medication that is supposed to protect dogs from pests.

Amy bought Sergeant's Sentry Pro XFC, a spot-on flea and tick product that’s supposed to be applied directly to the pet’s skin.

“[It] had a nice package on it, and I thought it's the most expensive one. So, it’s probably pretty good.”

She said she used the medication exactly as the packaging instructed. Then, she said she looked at the spot where she’d applied the medication.

“It looked like the worst sun burn you'd ever seen. It was obvious it was exactly where I’d applied it.” Amy said. “I gave him a bath, and washed it off. [That] worked until it got dry. Then, it came back. [Mack was] scratching, scratching and scratching. This went on and on until we gave him another bath.”

Amy said she went online, looking for answers. She found hundreds of posts complaining about the same problems.

“And, the other dogs had it worse,” she said.

Among the online posts were complaints of vomiting, seizures, burning and open wounds.

Those are just some of the side effects dog owners said some spot-on flea and tick medication has caused.

The ABC15 Investigators received videos and emails from dog owners across the country describing the “horror of watching our loved one suffer.”

One email described the pet’s reaction as like “watching them die.”

Many spot-on products use pesticides as the main active ingredient, because it kills pests like fleas and ticks.

The products that contain pesticides are regulated by the Environmental Protection Agency.

Now, the EPA is taking a close look at what it calls a large and growing number of cases involving spot-on products and reports of side effects such as tremors, seizures – even death.

According to the EPA's records, more than 24,000 incidents were reported in 2008 relating to all spot-on flea and tick products. Of those 24,000 incidents, more than 250 major cases and nearly 350 deaths were reported in just one year.

The most complaints were made against Sergeant’s.

Sergeant’s makes the product, Sentry Pro XFC. It’s the same medication that Amy said caused her dog’s side effects.

Sergeant’s received more than 10,000 complaints out of all the reports collected by the EPA from 2008. According to the EPA’s records, that’s more than three times the amount of complaints reported against any other company that makes flea and tick products.

Dr. Diane Paster is the Associate Director for Emergency Animal Clinics of Arizona. She said it’s common to see pesticides used in flea and tick medications.

“Anything that you're going to use that's going to kill these little guys has to be called a pesticide,” Dr. Paster said.

But Paster said the real problem may be the kind of pesticides being used. She said she tells her patients to only use flea and tick medications based on their vet’s recommendations.

“I think the ones that you can get from your vet a little bit safer...I think they're more effective,” she said.

According to the EPA's records, products sold by vets received fewer complaints.

“I would really like to see the [products] with the most side effects pulled,” Dr. Paster said.

In a statement to the ABC15 Investigators, Sergeant’s said:

“All of Sergeant’s flea and tick products are safe and effective when used properly. All meet government safety standards and have been approved by the EPA. Sergeant’s is not taking the products off store shelves because more than 99% of the millions of doses sold have provided pets and their owners with extremely effective protection from fleas and ticks and with no adverse reactions."

That is not the reaction Amy Vasquez wanted.

“I'd like it to be banned forever, taken off the shelves and not sold anymore,” Amy said.

In a statement to the ABC15 Investigators, the EPA said:

EPA is concerned about the increase in incidents associated with spot-on flea and tick products. In response, EPA undertook an extensive analysis of data associated with these incidents and followed with an announcement of ways to reduce the number of incidents in the future through a variety of changes to product labels, the registration process, and consumer outreach. EPA is also developing more stringent testing and evaluation requirements for both existing and new products.

Flea and tick products can be appropriate treatments for protecting pets and public health because fleas and ticks can transmit disease to animals and humans. Pesticides are poisons and safe use is important. Consumers must read and follow label directions, taking care to use the product that is appropriate for their pet. We believe that the changes EPA is seeking will reduce incidents related to these products. EPA is committed to addressing these incidents by implementing the necessary regulatory changes to ensure that these products can be used safely.

Incidents involving spot-on products for dogs and cats
Sergeant's Statement:

All of Sergeant’s flea and tick products are safe and effective when used properly. All meet government safety standards and have been approved by the EPA. Sergeant’s is not taking the products off store shelves because more than 99% of the millions of doses sold have provided pets and their owners with extremely effective protection from fleas and ticks and with no adverse reactions.

There is no consistency in the way that manufacturers report reactions to the EPA, therefore comparing one manufacturer’s numbers to another’s is like comparing apples to oranges. However, the vast majority of reports for Sergeant’s products were for minor skin irritations that were temporary. There will be cases in which some pets do have reactions to these products, just as humans may be allergic to milk or peanuts, for example.

Sergeant’s welcomes the EPA’s recommendations for the industry to improve the labeling and instructions for flea and tick spot-on products. This has been a concern at Sergeant’s for some time and prompted us a few years ago to launch our “Look at the Label” program to educate consumers about the safe and effective way to use flea and tick spot-on products.”

Bayer Statement:

“Although EPA did find an increase in the total number of adverse events during the period 2007 - 2008, Bayer Animal Health did not experience an increase in the rate of adverse events for our products during the same period.

We are in currently in discussion with EPA regarding further analysis and outcomes and strongly support their efforts to increase consumer education regarding the responsible and proper use of flea and tick products.”

Central Life Sciences (formally Wellmark International) Statement:

“On Wednesday, March 17, the United States Environmental Protection Agency (EPA) announced that it had concluded its evaluation of flea and tick control topical products including those sold in retail and veterinary channels. The EPA’s evaluation was prompted by an increase in the number of reported adverse effects to pets in 2007 and 2008 from these products. Highlights of the agency’s analysis determined that small breed dogs were most adversely affected and that the weight ranges for a dose volume (one tube) may be too wide for some products (smaller animals get more active ingredient per pound). In addition, EPA found that consumers were misusing dog products on cats. . For 2008, 270 million doses of topical products were sold with an incident rate of 0.00016 per dose (this equates to 1.6 incidents for every 10,000 doses sold. 97% of these incidents were classified as minor or moderate)
EPA has recommended that a number of steps may be needed including improved clarity on labeling to ensure that products intended for dogs are not used on cats, standardized adverse effect and sales reporting, and changes to the way products are registered so the EPA can make more informed decisions about the safety of products. We will be working closely with the EPA to learn more about its analysis and recommendations, as well as how Central Life Sciences can best address product specific concerns. Central Life Sciences will comply with EPA recommendations to help overcome pet owner confusion about the application of these products. At this time, no products have been recalled or recommended to be removed from store shelves and may continue to be sold and used as labeled.
For more than 35 years, Central Life Sciences has been committed to safeguarding the health and wellness of millions of pets, protecting them from health problems associated with fleas and ticks including anemia, flea allergy dermatitis, tapeworm infestation, and tick-related diseases. Many of our employees are dedicated pet owners, and we take these matters very seriously. It is this commitment that allows us to stand by the wide margin of safety of our products.
It is important to note that our products meet all EPA requirements, have undergone extensive testing to show effectiveness, and exhibit a wide margin of safety when used as directed. Central Life Sciences continues to urge pet owners to be diligent when using any flea and tick control products and to follow all label instructions carefully.”

Hartz Statement:

• “The Hartz Mountain Corporation believes that all pets deserve the best care possible. Safety is our number-one priority. We want to help families use our products properly to ensure the safety of their pets.

• We are confident in the quality of our topical flea and tick products, including Hartz® UltraGuard® and Hartz® InControl® brands for dogs and cats, all of which are held to the same safety and efficacy testing standards and labeling direction as all EPA-registered flea and tick products.

• While Hartz is the leader in flea and tick retail sales, Hartz flea and tick drops account for less than five percent of all adverse effects reported to the EPA in 2008 for topical dog and cat flea and tick treatments. Looked at another way, the EPA reported a total incident rate of 160 adverse reactions per million doses for all manufacturers. The incident rate for Hartz products is less than one third of that number – 46 reactions per million doses. Per the EPA, most reported incidents were classified as minor, meaning effects were minimally bothersome and rapidly resolved.

• Flea and tick protection is important to you and your pet. Ticks can transmit Lyme disease and Rocky Mountain spotted fever to both pets and people. Severe infestations can result in flea bites to people.

• All EPA-approved topical flea and tick products sold through retail channels are held to the same safety and efficacy testing standards as those brands purchased from veterinarians. Labeling direction mandated by the EPA is also consistent for all flea and tick prevention products sold through retail channels or veterinarian offices. We are confident in the quality and safety of our products, and will work with the EPA on labeling and other matters to make sure our consumers better understand the proper use of these products and use them with confidence.

• Customers who would like more facts about Hartz can visit www.hartzultraguard.com.”

Merial Statement:

“The EPA held a meeting with manufacturers of flea and tick products on March 17 at the agency’s Washington DC headquarters. The meeting’s purpose was to review the agency’s analysis of adverse event data connected to the use of these products.

Although EPA has said that its initiative was prompted by a ‘sharp increase’ it had noted in 2007-2008 in the number of reported adverse events related to the use of spot-on flea and tick control products in general, Merial’s data does not indicate that this is the case for FRONTLINE. The number of adverse events reported for FRONTLINE has remained consistently low since the product’s introduction in 1996.

The EPA’s analysis also shows that the overall numbers of adverse events reported for FRONTLINE products are extremely low and the vast majority are minor.

We will work cooperatively with the EPA to help pet owners continue to use our products properly.”

Summit Vetpharm Statement:

“The EPA’s findings support our company’s core value of protecting the veterinary exclusivity of Vectra products (Vectra 3D, Vectra for Cats, Vectra for Cats & Kittens and Vectra for Dogs & Puppies). These products should be dispensed by veterinary professionals who know and understand the medical condition, age, weight and parasites endemic to the area. Veterinarians often demonstrate the proper application procedure and reduce the confusion on dog and cat products dispensed for the same household. The evaluation further reinforces the value of Bloodhound Technology Summit VetPharm’s track and trace technology which allows us to track product from manufacturing to the delivery in the hospital which allows us to further build on the client/ pet/ doctor relationship thereby enhancing the health and safety of the pet.

The EPA’s findings reinforce the value of our package design and patented applicator:

a. Vectra products are clearly color-coded based on species and weight of the pet. The color-coding is on both the outside box and the applicator. Pet owners can easily distinguish between cat and dog products, and dose sizes to weight.
b. All products are packaged in a plastic clamshell, which features the embossed images of a dog or cat to further identify the proper species.
c. The no-drip applicator allows for more precise application by the pet owner.
d. All Vectra 3D packages advise the pet owner two times on the box and on each tube that it should not be applied to cats and this message is reinforced with “Use only on dogs and puppies”.
e. The package includes a question & answer pet owner educational brochure that reinforces the value of the veterinarian, and answering and communicating with the pet owner.
f. All product labeling has been reviewed and approved by EPA within the past 3 years.

Vectra products have experienced consistently low levels of adverse events for the entire Vectra line in 2007, 2008, 2009 and 2010. Our level of adverse events is low as a result of three things:
a. The active and the inactive ingredients in Vectra are proven safe to offer a wide margin of safety.
b. The innovative packaging supports proper application and use.
c. Our products are only available through veterinarians.

The EPA findings confirm a 2009 study conducted by the American Society for the Prevention of Cruelty to Animals which reported that the majority of illnesses were linked to proper use of topical flea and tick products were mild. Cats were more susceptible than dogs to illnesses and deaths from misuse of the products, the report said.
“The important take-home message is that although adverse reactions can occur with all flea and tick products, most effects are relatively mild and include skin irritation and stomach upset,” said Dr. Steven Hansen, ASPCA veterinary toxicologist and senior vice president for animal health services.

Summit VetPharm is confident in the safety of our Vectra products and we look forward to working with EPA in the coming months to further enhance labeling, as needed to protect pets. We will continue to support veterinarians who play a vital role in educating pet owners on parasite protection and proper application.”