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FDA Investigation into Potential Link between Certain Diets and Canine Dilated Cardiomyopathy

In July 2018, the FDA announced that it had begun investigating reports of canine dilated cardiomyopathy (DCM) in dogs eating certain pet foods containing a high proportion of peas, lentils, other legume seeds (pulses), and/or potatoes in various forms (whole, flour, protein, etc.) as main ingredients (listed within the first 10 ingredients in the ingredient list, before vitamins and minerals). Many of these case reports included breeds of dogs not previously known to have a genetic predisposition to the disease. The FDA’s Center for Veterinary Medicine (CVM) and the Veterinary Laboratory Investigation and Response Network (Vet-LIRN), a collaboration of government and veterinary diagnostic laboratories, continue to investigate this potential association. Based on the data collected and analyzed thus far, the agency believes that the potential association between diet and DCM in dogs is a complex scientific issue that may involve multiple factors.
We understand the concern that pet owners have about these reports: the illnesses can be severe, even fatal, and many cases report eating “grain-free” labeled pet food. The FDA is using multiple science-based investigative tools as it strives to learn more about the evolution of this outbreak of DCM and its potential link to certain diets or ingredients.
This update does not include reports received in December and January due to the lapse in appropriations from December 22, 2018, to January 25, 2019. Because the Anti-Deficiency Act does not except activities that are solely related to protecting “animal health,” FDA was not able to continue its investigation during that time.

To Continue reading this go to:  https://www.fda.gov/AnimalVeterinary/NewsEvents/ucm630993.htm?fbclid=IwAR3IJg_u1SHuzDwsPzS1N7THk3qgnKUN4se3Ble_3A2L2TTPsZ8FIeGxk_I 

A comparative illustration of a normal heart and a heart affected by dilated cardiomyopathy. Dilated cardiomyopathy is the most common type of cardiomyopathy often caused by coronary heart disease, diabetes, alcohol abuse, viral infections, thyroid disease, or genetics. The walls of the ventricles stretch and thin (dilate), creating an enlarged heart. This inhibits the heart’s ability to pump enough blood throughout the body and may also result in abnormal heart beats (arrhythmia).

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Some FDA Answers Regarding Investigation into a Possible Connection Between Diet and Canine Heart Disease

On July 12, 2018, FDA issued a public notification about the agency’s investigation into reports of canine dilated cardiomyopathy (DCM) in dogs eating certain pet foods. While it is early in the investigation, the Center for Veterinary Medicine recognizes that you may have questions. Below we have compiled answers to address some of the frequently asked questions raised by pet owners and veterinarians.

1. What potential connection is the FDA investigating?

FDA is investigating a potential dietary link between canine dilated cardiomyopathy (DCM) and dogs eating certain pet foods containing legumes like peas or lentils, other legume seeds, or potatoes as main ingredients. We began investigating after FDA‘s Center for Veterinary Medicine (CVM) received a number of reports of DCM in dogs eating these diets. DCM itself is not considered rare in dogs, but these reports are unusual because many of the reported cases occurred in breeds of dogs not typically genetically prone to the disease and were reported to have been fed the same type of diet (labeled as “grain-free”).

2. What is the FDA doing about this possible connection?

The FDA’s Center for Veterinary Medicine (CVM) and the Veterinary Laboratory Investigation and Response Network, a collaboration of government and veterinary diagnostic laboratories, are investigating this potential association. We are working with board certified veterinary cardiologists and veterinary nutritionists to better understand the clinical presentation of the cases. The agency has also been in contact with pet food manufacturers to discuss these reports and to help further the investigation. In addition, we are analyzing information from case reports submitted by pet owners and veterinarians. We will continue to work with all of these stakeholders to help advance our ongoing investigation.

3. What is canine dilated cardiomyopathy (DCM)?

DCM is a disease of a dog’s heart muscle and results in an enlarged heart. As the heart and its chambers become dilated, it becomes harder for the heart to pump, and heart valves may leak, which can lead to a buildup of fluids in the chest and abdomen (congestive heart failure). If caught early, heart function may improve in cases that are not linked to genetics with appropriate veterinary treatment and dietary modification.

4. Why did the FDA notify the public about the possible connection if the agency doesn’t have definitive answers?

While it is early in the investigation, the FDA’s Center for Veterinary Medicine (CVM) felt a responsibility to shed light on an early signal that we have been made aware of and to solicit reports from pet owners and vets that may know of related cases. The data provided through reports will help inform the investigation.

5. How many cases have been reported to the FDA?

Prior to issuing our public notification on July 12, 2018, the FDA received sporadic reports involving 30 dogs and seven cats. In the reports we received, some of the dogs showed signs of heart disease, including decreased energy, cough, difficulty breathing, and episodes of collapse. We are aware that the veterinary cardiology community has received more reports (approximately 150 as of 7/12/18). Since issuing the public notification, CVM has received many additional reports, but we are still in the process of reviewing them.

6. What brands of food have been included in the reports to the FDA?

There is a range of different brands and formulas included in the reports. Rather than brands, the common thread appears to be legumes, pulses (seeds of legumes), and/or potatoes as main ingredients in the food. This also includes protein, starch and fiber derivatives of these ingredients, (e.g., pea protein, pea starch, or pea fiber). Some reports we have received also seem to indicate that the pets were not eating any other foods for several months to years prior to exhibiting signs of DCM.

7. What are legumes?

Legumes are part of the Fabaceae plant family, and are the fruit or seed of these plants. Common legumes include peas, beans, lentils, chickpeas, soybeans, and peanuts. Legumes are used for both human and animal food and have become a common plant-based source of protein.

8. Does the FDA think this possible link includes diets with rice?

Rice is a grain, not a legume. The current reports do not suggest there is any link between diets with rice and DCM in dogs.

9. Are sweet potatoes and red potatoes classified as potatoes?

Yes.

10. What does the FDA consider a “main ingredient”?

There is no hard and fast rule for what qualifies as a “main ingredient.” We generally consider a “main ingredient” to be listed in a food’s ingredient list before the first vitamin or mineral ingredient.

11. Does the FDA know what it is about these foods that may be connected to canine DCM?

At this time, it is not clear what it is about these diets that may be connected to DCM in dogs. Taurine deficiency is well-documented as a potential cause of DCM, but it is not the only cause of DCM. Nutritional makeup of the main ingredients or how dogs process them, main ingredient sourcing, processing, amount used, or other factors could be involved.

12. How do I know if my pet’s food is one of the diets discussed in the FDA’s public notification?

We suggest reviewing the ingredient list on your pet’s food to see whether legumes and/or potatoes are listed as one of the main ingredients.

13. Should I avoid grain-free diets?

High levels of legumes or potatoes appear to be more common in diets labeled as “grain-free,” but it is not yet known how these ingredients are linked to cases of DCM. Additionally, legumes and potatoes may appear as ingredients in foods that are not labeled as “grain-free.” Changes in diet, especially for dogs with DCM, should be made in consultation with a licensed veterinarian.

14. Do I need to change my dog’s diet?

At this time, we are not advising dietary changes based solely on the information we have gathered so far. If you have questions or concerns about your dog’s health or its diet, we suggest that you consult your veterinarian for individualized advice that takes into account your dog’s specific needs and medical history.

15. What’s the safest diet for my dog?

Different dogs have different nutritional needs based on a number of factors, so nutrition advice is not one-size-fits-all. The FDA recommends consulting your veterinarian for personalized advice about what to feed your dog.

16. What should I do if my dog is experiencing symptoms of DCM?

If your dog is showing possible signs of DCM or other heart conditions, including decreased energy, cough, difficulty breathing and episodes of collapse, you should contact your veterinarian. Your veterinarian may ask you for a thorough dietary history, including all the foods (including treats) the dog has eaten.

17. How do vets and consumers submit reports to the FDA?

CVM encourages pet owners and veterinary professionals to report 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.

18. What information does the FDA need included in the reports?

Please see “How to Report a Pet Food Complaint” for additional instructions and information.

19. How long will the FDA’s investigation take?

There is no way to know how long the investigation will take, but CVM is hopeful that as we gather more data from case reports, we will gain a better understanding of this possible connection. We will continue to convey our observations publicly as the investigation progresses.
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FDA Alert – Grain-Free Dog Food

Jul 28, 2018
The U.S. Food and Drug Administration is investigating a possible link between incidents of canine dilated cardiomyopathy (DCM) in dogs and extended consumption of “grain-free” dog food, after several reports from veterinarians.
Earlier this month the Food and Drug Administration issued a warning to dog owners about a potential connection between diet (specifically a certain kind of dog food) and a disease called dilated cardiomyopathy or DCM.
The condition is one of the most common causes of heart failure in certain large dog breeds, such as Dobermans, Great Danes and Boxers, but reports received by the FDA show DCM occurring in breeds not usually prone to the disease, such as Retrievers, Whippets, even some mixed breeds.
The one common factor in the reported cases seems to be a diet high in things like potatoes, peas, lentils, legume seeds, which are often the main ingredients in dog foods labeled as “grain-free”. In the cases reported to the FDA, veterinarians indicated the dogs had been eating such foods consistently for months or years.
Several of the animals had low blood levels of the amino acid taurine. It has been shown that taurine deficiency can lead to DCM, and the FDA suspects that grain-free foods containing potatoes, peas and legumes might be causing the reduction of taurine levels in dogs.
No specific brands of dog food were listed in the FDA warning, but owners can check to see if potatoes, peas, lentils or legumes are listed as main ingredients in their pet’s food. Even better check with your veterinarian for recommendations about the best diet for your own furry friend.
So, how would you know if your dog might be suffering from dilated cardiomyopathy? Symptoms include coughing, difficulty breathing, reduced energy – if your buddy can’t play like it used to, or chase the ball, or gets winded easily, it’s time for a visit to the doctor. If your veterinarian suspects your pet may have DCM linked to its diet, report it to the FDA.
You can read the FDA warning about the potential connection between diet and canine heart problems by visiting the agency’s website at FDA.gov.
We all want to do what’s best for our four-footed friends, including feeding them a healthy diet. But for dogs, “grain-free” may not be the best choice, especially when we’re speaking of pets.
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FDA Alerts Veterinarians and Pet Food Manufacturers about Potential Presence of Thyroid Hormones in Pet Foods and Treats

March 27, 2017

The U.S. Food and Drug Administration is advising pet owners and caretakers, veterinarians, and the pet food industry to be aware that pet food and treats made with livestock gullets (meat from the throat region) have the potential to contain thyroid tissue and thyroid hormones. Pets that eat food or treats containing thyroid hormones may develop hyperthyroidism, a disease that is rare in dogs and usually triggered by thyroid cancer.

Symptoms of hyperthyroidism include excessive thirst and urination, weight loss, increased appetite, restlessness, hyperactivity, elevated heart rate, rapid and/or labored breathing, vomiting, and diarrhea. Continued exposure to excess thyroid hormones can cause damage to the heart and in some cases, death.

The FDA is issuing this alert now after a recent Center for Veterinary Medicine investigation into reports of three dogs in different households that showed signs of hyperthyroidism. In these cases, extensive testing on all three dogs conducted at a reference laboratory showed elevated thyroid hormone in the blood, but ruled out thyroid cancer. Reference lab interviews with the dogs’ owners revealed that all three dogs had been fed BLUE Wilderness® Rocky Mountain Recipe TM Red Meat Dinner Wet Food for Adult Dogs and/or Wellness 95% Beef Topper for Dogs.

Based on the recommendation of the reference lab’s consulting veterinarian, the feeding of these dog foods was discontinued. After the dogs stopped eating these products for a few weeks, their clinical signs disappeared and thyroid hormone levels returned to normal. An FDA lab tested unopened cans of BLUE Wilderness® Rocky Mountain Recipe TM Red Meat Dinner Wet Food for Adult Dogs and Wellness 95% Beef Topper for Dogs and confirmed that they contained active thyroid hormone. The source of thyroid hormones is likely from the use of gullets from which the thyroid glands were not completely removed before adding to pet food or treats.

After consulting with the FDA, both WellPet (the maker of Wellness) and Blue Buffalo (the maker of Blue Wilderness) initiated voluntary recalls of select lots of the affected products on March 17, 2017.

WellPet voluntarily recalled of certain lots of 13.2 ounce cans of Wellness 95% Beef Topper for Dogs with best-by dates of 02 FEB 19, 29 AUG 19, and 30 AUG 19 printed on the bottom of the can. The UPC Code is 076344894506.

Blue Buffalo Company voluntarily recalled of one lot of 12.5-ounce cans BLUE Wilderness® Rocky Mountain Recipe TM Red Meat Dinner Wet Food for Adult Dogs with a best-by date of June 7, 2019 printed on the bottom of the can. The UPC code is 840243101153.

The FDA appreciates the cooperation and swift action taken by both firms to address this issue. If your dog has eaten either of these foods and is showing symptoms of hyperthyroidism, discontinue feeding of these foods and consult your veterinarian, making sure to provide your dog’s dietary history, including what the dog has been eating, how much, and for how long.

Consumers who have any of the recalled food should not feed it to their animals and can refer to the company press releases for further instructions about returns/refunds.

Questions about whether a particular pet food or pet treat product contains livestock gullets and/or thyroid hormones should be directed to the product manufacturer.

The FDA provides more detailed information about the issue of thyroid hormones in pet food in its Letter to Veterinary Professionals and Letter to Industry.

Link to this information:   https://www.fda.gov/AnimalVeterinary/NewsEvents/CVMUpdates/ucm548883.htm

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