The U.S. Environmental Protection Agency recently asked the manufacturers of spot-on flea and tick products for pets to provide additional detailed data on reported incidents, including breed, weight, age and sex of pet; whether the pet was treated by a veterinarian; whether the product was applied according to the label; whether this was the first time the pet owner used the product; and whether the pet was being treated with other medications or pesticides; among others.
The EPA, which implemented a July deadline for the data, also requested information on market share and numbers of incidents per doses or packages sold.
The request is part of the agency’s “increased scrutiny” of spot-on flea and tick control products in both the over-the-counter and veterinary channel to determine if further restrictions on such products are needed.
The EPA had announced in April that it was intensifying its evaluation due to recent increases in the number of reported incidents. About 44,000 potential incidents associated with registered spot-on products were reported to the agency in 2008.
Federal law requires EPA registrants to submit reports of possible adverse reactions that may be related to the use of their products, whether or not the products were used properly and according to label instructions. A report does not indicate a cause-and-effect relationship between products and symptoms.
Although flea and tick product incidents can involve the use of spot-ons, sprays, collars and shampoos, the majority of incidents reported to the EPA are related to EPA-registered spot-on products.
Spot-ons are generally sold in tubes or vials and are applied to one or more areas on the pet, such as between the shoulders or in a stripe along the back. The active ingredients in these products are amitraz, cyphenothrin, dinotefuron, etofenprox, fipronil, imidicloprid, metaflumizone, permethrin, pyriproxyfen and S-methoprene.
Adverse reactions reported in relation to the spot-on products range from skin irritation to seizures and in some cases death, according to the EPA.
The EPA, which has posted a list of spot-on products on its website, reiterated that it is not recalling products nor is it suggesting that these products not be used.
Specifically, the EPA urged pet owners to carefully follow label directions and to monitor their pets for adverse reactions after application, particularly when using a product for the first time. The EPA also recommended that pet owners consult a veterinarian about “the responsible and effective use of flea and tick products.”
The EPA held a meeting in May with representatives from the industry, the U.S. Food and Drug Administration and Health Canada, which has identified similar concerns about the use of spot-on flea and tick products. The meeting discussed reported adverse effects on pets associated with flea and tick products, ongoing agency actions related to the reported incidents, additional information/data needs and a path forward for addressing the issue of pet incidents.
The EPA’s internal DVM team now plans to review domestic animal safety data, incident data and the additional information that was requested of the manufacturers. It is also considering whether the domestic animal safety studies are sufficient for such products.
The EPA said this information will help it take the necessary steps to reduce the number of incidents, which may lead to label revisions, cancellation of products and/or new data requirements.
The EPA plans to complete its analysis this fall, but noted that it will continue to update its website with additional information as it becomes available.