Spot On - Part Two

Previously, we looked at the problems some people are having with spot-on flea and tick products. Now let's take a look at the EPA's findings, their recommendations, and the steps they are taking.

In response to an apparent increase in reports about dangerous side effects of spot-on flea and tick product, the U.S. Environmental Protection Agency is investigating the pesticides used in these medications. The products in question are generally sold in tubes or vials and applied locally to the pet's skin.

While the EPA said these products are useful to protect people and their pets from fleas and ticks, they now recommend precaution. People should watch their pets closely for any adverse reactions.

The EPA is also looking to see if certain chemicals in these products have a higher rate of side effects. Dr. Charles T. Gaskin, a Washington State University professor, studied the complains received by the EPA and stated that the chemical Cyphenothrin accounted for 43% of the reported reactions. Two other chemicals combined - Imidacloprid and Fipronil - accounted for 30% of negative reactions. All active ingredients are being examined, as well as the inert (inactive) ingredients that are not identified on the labels. They are also studying possible misuse of the products by pet owners.

The ASPCA's Animal Poison Control Center also examined its data from pet owners' calls about these products. They found two key things about the use - or misuse - of topical flea and tick chemicals.

According to their findings, when dogs and cats were treated according to the directions, the likelihood of severe adverse reactions was significantly less: 7% no illness despite call, 69% mild illness, 22% moderate illness, 2% major illness, and .1% death.

They stated that when pet owners did not follow the directions properly, the animals were significantly more likely to have a severe reaction: 18% no illness despite call, 17% mild illness, 45% moderate illness, 2% major illness, and 2% death.

Dr. Steven Hansen, ASPCA veterinary toxicologist and Senior Vice President Animal Health Services, says "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. Pet parents should not discontinue using products as directed by the product label when faced with a flea infestation."

EPA officials have indicated that misuse of the products - such as treating cats with products made for dogs - was behind many adverse reactions. Pet owners, however, are insisting they used the flea and tick products exactly as instructed, or used less than the recommended dose.

Dale Kemery, a spokesman for the EPA, states that "while we do recommend that pet owners consult their veterinarian if they have questions or concerns about the use of flea and tick products, there is no reason to believe that products purchased from reliable sources are counterfeit or substandard, or that pet owners are not capable of following product label directions." Kemery said consumer error doesn't explain everything. "There are issues that go beyond the misuse of the products. We cannot attribute a particular proportion of incidents to inappropriate use versus other issues. Clarity of label instructions and the weight bands for doses are key issues that need to be addressed."

On March 17, 2010, the EPA met with representatives of the companies that market these products and Canada's Pest Management Regulatory Authority (PMRA) to discuss their analysis of the incident reports, the Agency's conclusions, and an action plan needed to minimize adverse effects to pets. Canada has had similar concerns. They have very similar products registered, and some from the same companies as those sold in the U.S. The USDA is also working with the FDA since they regulate some similar products, and the USDA wanted to learn about their processes and its experience of incidence with animal drugs.

Their findings were that most incidents were minor, but unfortunately there were some severe reactions and some pet deaths. Small breed dogs were affected more than large breeds, and cats were equally affected. The amount of a single dose needed to vary more for small to large dogs to prevent overdosing. Label warnings against the use of dog products on other animals, especially cats, are not working well enough and need to be evaluated. The Agency also found that the data now required to determine the safety of these products for pets does not accurately predict the toxicity seen in the incidents reported. They determined that mitigation is necessary to prevent adverse effects to pets.

Based on the results of their analysis, the EPA presented a regulatory action plan to help prevent future incidents. Some of their recommendations are:

• Narrowing the weight ranges for some products to reduce the likelihood of overdosing (more catagories for weight ranges).
• Changing the names on the products so that dog and cat products are more easily distinguished from one another.
• Make labels more understandable (larger fonts, pictograms).
• Providing more information on inert (inactive) ingredients and prohibiting alternative formulas.
• Requiring a standard reporting procedure for adverse reactions.
• Requiring a range of animal types to be used for safety testing to account for variations in breed sensitivities, ages, and body sizes.
• Conduct pre-market clinical trials.
• Conditional registration for new products, meaning that future registrations for topical products will be restricted by appropriate conditions and time limitations to allow the EPA to monitor the safety of these products after they hit the market.
• Post-market surveillance reporting on incidents.

Most manufacturers would not comment on anything because of several on-going class-action suits. They did, however, express support for changes being proposed by the EPA to address the safety of topical products as a whole.

Dr. Michael Dryden, a professor of veterinary parasitology at Kansas State University, applauded the EPA's proposals. "I would say, it's about time," said Dryden, whose expertise in the field has earned him the nickname Dr. Flea. "Virtually everything they talked about will make things better.'

Dryden added that despite the problems identified by the EPA, modern topical flea and tick products are far safer and more effective than parasite control of 20 years ago. "Animals used to die all the time from insecticide application. We are exposing ourselves, too, to these insecticides and these dips and these foggers. We are so much better off today than we were then."

So, with all this information about the products, their uses, and their possible risks, how can I make sure my pet will not be harmed when I use a spot-on flea and tick products?

I will post another entry shortly to address the correct usage, precautions, and signs of problems. I will also list actions to take and who to contact in the event of an adverse reaction.

For further reading and more in-depth information on the EPA's study, go to their site at:

http://www.epa.gov/pesticides/health/petproductseval.html

The EPA's Protecting Pets website:

http://www.epa.gov/pesticides/health/pets.htm

Enhanced reporting of the investigation, the chemicals used, and the companies and individual products that were analyzed:

http://www.regulations.gov/search/Regs/home.html#documentDetail?R=0900006480abc643