Tag: grain-free

574 Companion Animals Stricken with DCM. No answers yet

The US Food and Drug Administration (FDA) received a total of 524 reports of companion animals stricken with dilated cardiomyopathy (DCM) between January 1, 2014 and April 22, 2019, according to an update released by the agency today.

Some of the reports involve multiple animals in a single household. In all, DCM was reported in 560 dogs and 14 cats. Five cats and 119 dogs died.

Only seven reports were lodged with FDA during calendar years 2014-2017. The number of incidents spiked to 320 in 2018, and have continued at a steady pace this year, with 197 cases reported between January 1st and April 30th 2019.

FDA has posted a spreadsheet containing all of the individual reports it has received.

BY THE NUMBERS

The ten breeds appearing most often in these reports include: Golden Retriever (95), Mixed (62), Labrador Retriever (47), Great Dane (25), Pit Bull (23), German Shepherd (19), Doberman Pinscher (15), Australian Shepherd (13), Unknown (13) and Boxer (11).

DCM is recognized as a genetic condition in some large or giant breed dogs, including the Doberman Pinscher, the Great Dane, and the Irish Wolfhound, manifesting mainly in male dogs in middle to older age. DCM also is associated with taurine deficiency in Cocker Spaniels.

In contrast, cases of DCM reported to FDA have involved a wide range of dog breeds of all sizes and ages, from 0.4 – 17 years in dogs and 7 – 13 years in cats. More than one half of the cases (58.7% of dogs and 62.5% of cats) involve males.

The vast majority of affected pets (452 of the 524 reports) were fed a dry food diet exclusively. The rest of the animals were fed a diet that included one or more of dry, raw, semi-moist or wet foods. 

More than 90% of the dry dog foods were grain-free. Ninety-three percent of the formulations contained peas and/or lentils. Forty-two percent contained potatoes or sweet potatoes.

The most common animal source proteins were chicken, lamb and fish. Some foods contained exotic meats, such as kangaroo or bison. No one animal protein source predominated in the illness reports.

Dry food brands named most frequently in DCM cases were Acana (67), Zignature (64), Taste of the Wild (53), 4Health (32), Earthborn Holistic (32), Blue Buffalo (31), Nature’s Domain (29), Fromm (24), Merrick (16), California Natural (15), Natural Balance (15), Orijen (12), Nature’s Variety (11), NutriSource (10), Nutro (10) and Rachael Ray Nutrish (10).

THE FDA INVESTIGATION

FDA’s Veterinary Laboratory Investigation and Response Network (Vet-LIRN) has analyzed multiple products for minerals and metals (calcium, magnesium, phosphorus, iron, cobalt, copper, zinc, selenium, iodine) and amino acids including taurine, cysteine, and methionine. No abnormalities were found.

A comparative test of grain-free and grain-containing products for levels of protein, fat, moisture, crude fiber, total dietary fiber, soluble fiber, insoluble fiber, total starch, resistant starch, cystine, methionine and taurine revealed that both types of products contained similar levels of all of these components on a dry matter basis (ie., after removing all moisture content).

Additional tests are in progress

Vet-LIRN has interviewed 95 owners of affected pets, in order to document a complete dietary history and to explore any other possible contributing factors, including environmental factors.

FDA has received results of 19 gross necropsies from dogs with suspected heart disease, and Vet-LIRN is processing tissues from the necropsies for review by a board-certified veterinary pathologist.

Vet-LIRN is collaborating with Chesapeake Veterinary Cardiology Associates (CVCA) to collect medical records, owner interviews, and diagnostic samples from pets diagnosed with DCM. CVCA will be following the medical progress of these pets, including regular collection of diagnostic samples and follow-up echocardiogram. Vet-LIRN is collecting food associated with the pets included in this study for lab analysis.

UNANSWERED QUESTIONS

  1. Why have cases of DCM spiked in recent years? What has changed?
  2. Why are grain-free products so strongly associated with DCM, even though there is little apparent difference in the levels of minerals, amino acids, protein levels, etc. between grain-free and grain-containing products?
  3. Acana (67 DCM reports) and Orijen (12 DCM reports) are both manufactured by the same company. Why is there such a large difference in the number of associated cases between these two brands?
  4. Is there any correlation between brand popularity and number of DCM case reports? Would it be useful to compare the report frequency to the market share of each product?

WHAT CAN PET OWNERS AND VETERINARIANS DO?

  • FDA encourages pet owners and veterinarians to submit reports on any food-associated pet illness. Details for submitting this info can be found on the FDA page “How to Report a Pet Food Complaint.”
  • Pet owners should contact a veterinarian as soon as possible if their dog is showing possible signs of DCM or other heart conditions, including decreased energy, cough, difficulty breathing and episodes of collapse.
  • Veterinarians are urged to report well-documented cases of DCM in dogs suspected of having a link to diet by using the electronic Safety Reporting Portal or calling their state’s FDA Consumer Complaint Coordinators. FDA especially welcomes detailed reports, including information about feeding history, medical records, and diagnostic testing.

AN EDITORIAL NOTE

I have sometimes read complaints from pet owners and at least one blogger that FDA doesn’t care about pet food safety, or about the health of companion animals. 

The agency has spent significant resources and manpower on this investigation for more than a year, and is continuing its efforts to find the root cause for the spike in DCM in dogs. This is a complex, difficult, and wide-reaching investigation with no guarantee of success.

In my opinion, FDA’s commitment to solving the DCM riddle bears witness to its dedication to pet health.

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Cause of increased canine, feline DCM incidence remains a mystery

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

Between Jan. 1, 2014, and Nov. 30, 2018, the Food and Drug Administration received reports of 325 cases of dilated cardiomyopathy (DCM) involving dogs, and 10 involving cats, according to an investigation update released Feb. 19. Two of the cats died, as did 74 of the dogs.

In some cases, more than one pet in a household was affected. 

In July 2018, FDA announced that it had begun investigating reports of DCM in pets who were fed certain pet foods containing high proportions of peas, lentils, pulses and/or potatoes. Many of the implicated pet foods are advertised as “grain-free.” Most of the reports, 276 out of 300, were received following the FDA’s announcement.

The investigation update does not include data from December 2018 or January 2019, as the partial government shutdown prevented FDA from continuing its investigation during that time period.

DCM is a recognized genetic condition in some dog breeds, including doberman pinschers, great danes, and Irish wolfhounds. It also has been reported in cocker spaniels.

Animals suffering from DCM develop an enlarged heart and may display symptoms such as decreased energy, cough, difficulty breathing and episodes of collapse. If caught early, the condition can be partially reversed with appropriate treatment and diet modifications.

The current spate of DCM reports is not limited to dog breeds known to have a genetic predisposition to the disease, but includes the following breeds, in descending order by frequency of reports: golden retrievers, mixed breed dogs, Labrador retrievers, great danes, Australian shepherds, German shepherds, pit bulls, boxers, doberman pinschers, mastiffs, American cocker spaniels, standard poodles, Shetland sheepdogs, weimaraners, French bulldogs, Australian cattle dogs, Boston terriers, bulldogs, samoyeds, and shih-tsus.

Other breeds with more than one case report include: Afghan hound, beagle, dalmatian, English springer spaniel, flat-coated retriever, unspecified hounds, Maltese, miniature schnauzer, pomeranian, Portuguese water dog, pug, unspecified retriever, Rhodesian ridgeback, rottweiler, saluki, vizsla, and Yorkshire terrier.

Ages of affected dogs range between less than 6 months to 16 years. Dogs suffering from DCM weighed between 8 pounds and 212 pounds. More male dogs than female dogs have been affected.

In contrast, genetically related DCM tends to involve middle-aged to older aged male dogs of large and giant breeds.

The majority of cases reported to FDA, 269 of 325, involved dogs fed dry foods, approximately 90 percent of which were reported to be “grain-free.” Although most of the diets included an animal protein, such as fish, eggs, lamb or chicken, no single source predominated.

Since beginning its investigation, FDA’s Veterinary Laboratory Investigation and Response Network (Vet-LIRN), has tested various products for minerals and metals including calcium, magnesium, phosphorus, iron, cobalt, copper, zinc, selenium and iodine. They also tested for amino acids, including taurine, cysteine and methionine. Cysteine and methionine are required for the body to manufacture taurine.

In addition, Vet-LIRN has tested both grain-free and grain-containing products for protein, fat, moisture, crude fiber, total dietary fiber, soluble fiber, insoluble fiber, total starch, and resistant starch. Grain-free products were higher in fiber and lower in starch than grain-containing products. Otherwise, there was very little difference between the grain-free and grain-containing products.

FDA has received lab reports, diagnostic records such as echocardiograms, and necropsy reports from some of the affected dogs. In addition, the agency is collaborating with Chesapeake Veterinary Cardiology Associates (CVCA) on a prospective study of DCM-diagnosed dogs. 

CVCA is collecting medical records, owner interviews, diagnostic samples from each of the diagnosed animals, and is archiving feces and DNA samples for possible future testing.

FDA also has been working with Drs. Lisa Freeman of Tufts University, Joshua Stern of the University of California-Davis, and Darcy Adin of the University of Florida. Stern has been studying the increases in DCM cases in golden retrievers. Many of these cases are associated with taurine deficiency.

The FDA reported it is not aware of similar DCM illness reports or investigations in other countries, according to a spokesperson for the agency, adding that FDA would welcome the opportunity to collaborate with international counterparts on diet-related DCM. 

A number of researchers in Canada and the United States, led by W.D. Mansilla of the University of Guelph in Ontario, Canada, recently issued a report on the association between DCM and pulse ingredients in pet food. They suggested L-carnitine deficiency as another possible avenue of investigation into the cause of non-hereditary DCM.

L-carnitine, an amino acid, occurs naturally in animal protein, but is absent from plant protein. It is present at highest concentration in red meats such as lamb and beef, and at a lower level in pork, poultry and fish.

When asked whether FDA was examining the possible effect of L-carnitine on the development of DCM, an agency spokesperson said the agency and its investigative partners “. . . are considering or open to considering any science and evidence-backed theory.”

Guidance to pet owners and veterinarians
If a dog is showing possible signs of DCM or other heart conditions, including decreased energy, cough, difficulty breathing and episodes of collapse, contact your veterinarian as soon as possible. If the symptoms are severe and your veterinarian is not available, you may need to seek emergency veterinary care. Be prepared to provide your veterinarian with a thorough dietary history, including all the foods (including treats) the dog has eaten.

The FDA encourages veterinary professionals to report well-documented cases of DCM in dogs suspected of having a link to diet by using the electronic Safety Reporting Portal or calling their state’s FDA Consumer Complaint Coordinators.

The more information veterinarians provide, particularly feeding history, medical records, and diagnostic testing, the better. Detailed instructions can be found on “How to Report a Pet Food Complaint.” Technical veterinary information that may aid veterinarians can be found in the agency’s Vet-LIRN Update – February 2019.