Pet Health – Page 55

This story by Phyllis Entis first appeared in Food Safety News and is reposted here with permission.

On May 8 Champion Petfoods USA Inc. was informed that three shipments of beef tallow delivered by their supplier were contaminated with pentobarbital, a tranquilizer often used to euthanize sick or fatally injured animals.

Ingestion of the barbiturate can cause drowsiness, dizziness, excitement, loss of balance, or nausea, or in extreme cases, possibly death of dogs and cats. Beef tallow is promoted as an inexpensive, palatable, and stable source of energy, with a nutritional profile “sufficient for safe use as a pet food ingredient,” according to an industry website, BeefTallow.com.

Champion, a Canadian pet food company whose U.S. production facility is in Auburn, KY, manufactures Acana and Orijen brands of dry dog food.

The company ceased manufacturing products that require beef tallow, and quarantined the three pentobarbital-contaminated lots of tallow. However, by the time the company learned of the problem, some of the tallow already had been used.

Champion initiated pentobarbital testing on the retained samples from the beginning, middle and end of the affected production lots, and retrieved finished product from its third-party distributors.

The retained samples tested for pentobarbital were found to be negative. Some of the finished products containing contaminated tallow were distributed to the store/consumer level, but no retail-level product recall was initiated.

On May 16 the Food and Drug Administration initiated an inspection of Champion’s facility, according to information contained in the agency’s Establishment Inspection Report (EIR), which was obtained by Food Safety News in response to a Freedom of Information Act request.

During the inspection, the company informed FDA that Champion was no longer doing business with the Pennsylvania supplier of beef tallow and consulted with the agency on how to properly dispose of the pentobarbital-contaminated tallow.

The name of Champion’s tallow supplier was blacked out in the EIR.

Champion advised FDA inspectors that it will require its new supplier of tallow to include test results for pentobarbital on Certificates of Analysis accompanying all shipments of the ingredient. FDA investigators appeared satisfied with Champion’s response to the contaminated tallow episode, classifying the outcome of the investigation as “No Action Indicated.”

Since the beginning of 2017, pentobarbital contamination has triggered the recall of canned pet foods manufactured by Evanger’s Dog and Cat Food Co. and Big Heart Brands.

The source of pentobarbital contamination in the Evanger’s products was never established.

Beef tallow was the apparent source of pentobarbital contamination in Big Heart Brands’ canned pet foods. According to information contained in a class action complaint filed against the manufacturer of Gravy Train and other canned dog foods, Big Heart’s tallow supplier was MOPAC, a Pennsylvania rendering facility belonging to JBS USA Holding Inc.

Big Heart Brands packs several popular brands of pet food that are distributed nationwide. Those brands include Gravy Train, Kibbles ’N Bits, Skippy and Ol’ Roy brands. Big Heart Pet Brands distributed the Gravy Train, Kibbles ’N Bits and Skippy dog food to retailers nationwide. Walmart Stores Inc. distributed the Ol’ Roy dog food.

The US Food and Drug Administration (FDA) today issued an alert to pet owners and veterinarians about possible neurological effects from use of certain flea and tick treatment products.

According to a spokesperson for FDA, as of July 31, 2018, the Center for Veterinary Medicine has received approximately 5400 reports of ataxia (difficulty standing/walking), muscle tremor, and/or seizures, in dogs and cats that received an isoxazoline product, out of millions of animals that have received one or more doses since these products came on the market.

Products containing isoxazoline products include: Bravecto, Credelio, Nexgard and Simparica and may be available in either a topical or a chew format, depending on the product.

Some of the neurological symptoms were seen during pre-market studies of these products, and the labels for some of the products already note the potential for neurologic events. Following a scientific evaluation of both the pre-market and post-market reports, FDA has determined that a label change is warranted across the category of isoxazoline products.

FDA urges pet owners to be on the alert for any neurologic effects after administering one of these products to their dogs or cats, and to report any adverse effects to the manufacturer or directly to FDA.

To report suspected adverse drug events for these products and/or obtain a copy of the Safety Data Sheet (SDS) or for technical assistance, contact the appropriate manufacturers at the following phone numbers:

Merck Animal Health (Bravecto): 800-224-5318
Elanco Animal Health (Credelio): 888-545-5973
Merial (Nexgard): 888-637-4251
Zoetis (Simparica): 888-963-8471

If you prefer to report directly to the FDA, or want additional information about adverse drug experience reporting for animal drugs, see How to Report Animal Drug Side Effects and Product Problems.