Dilated Cardiomyopathy in Dogs & Cats: Complaints Submitted to FDA-CVM January 1, 2014 – April 30, 2019 This document compiles all reports of dilated cardiomyopathy in dogs and cats that were reported to the FDA between January 1, 2014 and April 30, 2019. Reports are listed in chronological order from oldest to newest. Unless otherwise noted, each report is displayed as it was reported to the FDA and in the words of the person who submitted the report. In some cases, lengthy report narratives continue into multiple cells of the spreadsheet. In a small number of reports, lengthy case narratives were edited for brevity. These reports were not originally prepared for public distribution. As such, each instance of personally identifiable information (e.g., names, locations, dates, etc.) has been redacted and replaced with (b)(6), which refers to Exemption 6 of the Freedom of Information Act. This exemption “protects information about individuals in personnel, medical, and similar files when disclosure would constitute a clearly unwarranted invasion of privacy.” To learn more, see FOI Information. June 2019 Canine Dilated Cardiomyopathy Complaints Submitted to FDA-CVM Through April 30, 2019 Page 1 of 77 Product Name Species Breed Age Age UOM Gender Weight Weight UOM Description Hills prescription diet u/d canned Dog Dalmatian 8 Years Male 96.4 Pound Hills Prescription U/D caused developmental cardiac deficiencies in our dog (b)(6). We believe it is unsafe to be used in canines over food and dry food any length of time. We have extensive medical records for proof of this fact. (b)(6) was diagnosed with urolithiasis in March 2007 and after surgery was prescribed Hill Prescription Diet U/D dry and canned food. This was his only source of nutrition along with baby carrots as treats. On May 15, 2013, he developed an unusual cough which was continuous for the entire afternoon and evening. He woke up coughing at 3:00am as well. The next day I took him to the vet we were seeing at that time. He received an ECG after the vet heard a gallop heartbeat. He was diagnosed with dilated cardiomyopathy and we immediately went to (b)(6) to the cardiology department. At that time, he was diagnosed with congestive heart failure and started on enalapril, LASIX, taurine, L-carnitine , , and fish oil. His diet was changed to Royal Canine, low purine and Hill's L/D at the recommendation of the (b)(6) Nutrition Department. At that time, his cardiologist, Dr (b)(6), suspected that his heart disease was nutrition related. Hill U/D does not have enough of the proper nutrients in it to allow for adequate heart development and function. We knew that several months would have to pass before we knew for certain if this was indeed the case. We took him back to the cardiologist in August and he was showing some mild improvement. We took him again and February and the improvement in his heart function was astonishing. He still has dilated cardiomyopathy but it is improving vastly with his dietary changes. The improvements are not seen with heart medications alone according to his medical records. His long term prognosis is still uncertain but continued improvement is hoped for. It is not common knowledge among general veterinarians that this food is unsafe for long term use. This food should come with a warning label at the very least. I request that it be pulled from the market as it is the catalyst for heart disease and unsafe for canine consumption. EVO Grainfree Turkey and Cat Himalayan 2 Years Female 6.6 Pound I breed Persian and Himalayan kittens. My breeders regularly have cardiac ultrasounds to make sure their hearts are normal and Chicken Formula Cat and Kitten remain normal. On (b)(6), (b)(6) had a Cardiac Ultrasound performed at (b)(6) in (b)(6). Her heart was found to be normal. In January, 2015, I switched my whole Cattery over to the EVO Turkey and Chicken Cat and Kitten dry food. At the same time, four of my breeding girls were pregnant. All four mothers had normal babies while on the food. On 6/30/15, I took (b)(6) down for her two year old heart scan at (b)(6) in (b)(6). At the time, she was nursing 6 kittens. During her heart scan, it was found that she had mild Dilated Cardiomyopathy (DCM). This came as a shock since I have never had any of my breeders have this heart disease. Dr. (b)(6) of the (b)(6) put her on Vetri-Science Cardio Supplements once a day and told me to bring her back for another scan in six months. Upon researching DCM, I found that the main cause could be lack of Taurine in the diet. Since I had just started the EVO food in my Cattery in January 2015, I was suspecting the food as the cause of a Taurine Deficiency causing the DCM. I also knew that EVO had a voluntary recall of this exact food in November 2014 for inadequate supplements in the food. So on June 30 2015, I put all kittens and cats in my Cattery on Taurine Supplementation of 250 mg per 1 cup of dry food. I also added in Doc Roy's Absorb More to ensure that nutrients where being absorbed by everyone. I also placed (b)(6) on this additional supplementation. So she would be getting roughly 500 mg of Taurine supplementation as well as the Absorb More. I also took (b)(6) away from the 6 kittens she had been nursing as soon as I found out on June 30, 2015. I was worried that they too might have a Taurine deficiency from her milk. On July 21, 2015, three weeks after putting her on the Taurine supplementation of 500 mg a day, I took her back down to (b)(6) in (b)(6) for another Cardiac Ultrasound to see if there was any improvement in her heart. To my Vet's surprise, she had a "marked improvement" in her DCM. In fact, her heart was almost back to normal. This can be documented on each Scan's report with the measurements. It is my Vet's opinion, as well as my own, that this food, EVO Turkey/Chicken Cat/Kitten dry food is lacking in Taurine, an essential amino acid that is required to be in all cat foods. It is also our opinion that maybe the Taurine gets put in the food but because of the high processing of the food, that the Taurine becomes not viable. Since most cats on EVO do not have regular Cardiac Ultrascans, there is no way of a pet parent or even breeder to know (*continued below) *Continued *Continued *Continued *Continued *Continued *Continued *Continued *Continued (Continued from previous report) that their cat might have DCM. Symptoms of DCM are very much similar to HCM. On July 28, 2015, I contacted EVO Customer Service and reported the problem. They did not ask for the Cardiac Ultrasound results. I did state to them that I had kept all information of the bags of EVO purchased since March 13, 2015. I go through lots of bags of EVO dry food at my Cattery and due to all their past recalls thought this was a wise move. I do not have manufacturing codes for bags bought between Jan 1, 2015 and March 13, 2015. But since the kittens were born normal, my gut feeling tells me this problem of Taurine Deficiency occurred after the birthing of the 4 litters ... between April 4, 2015 and forward. Rachael Ray Nutrish Cat Domestic (unspecified) 4 Years Male 12 Pound He developed cardiomyopathy and is in critical condition. He has congestive heart failure. Our other two cats are ill as well. (b)(6) is nearly as bad as (b)(6), with both cardiomyopathy and congestive heart failure. Both (b)(6) and (b)(6) had been eating the food for six months. Our third cat, (b)(6), has been eating the food for two months and is beginning to exhibit early signs of heat disease. There is no genetic relation between the cats, they do not have kidney disease, and they have not been exposed to the types of toxic plants that could cause their illness. The only common denominator is the Rachael Ray Nutrish food. The vet suspects a taurine deficiency is the only explanation, which should not happen with commercial pet food. Canine Dilated Cardiomyopathy Complaints Submitted to FDA-CVM Through April 30, 2019 Page 2 of 77 Product Name Species Breed Age Age UOM Gender Weight Weight UOM Description Merrick Purrfect Bistro Grain Cat Mixed (Cat) 12 Years Female 5.3 Kilogram Presented 5/8/2016 for lethargy; on physical exam the patient was dyspneic and pleural effusion identified on cursory ultrasound and Free Real Chicken Recipe DV thoracic x-rays - given lasix and placed in oxygen. Transferred to cardiology service; evaluation including echocardiogram on 5/9/16 revealed dilated cardiomyopathy, moderate left atrial enlargement, pleural effusion and azotemia. Plasma taurine was submitted to University of Wisconsin. Lab results received 5/15/16 - plasma taurine 24nmol/ml (ref range 60-120, critical level <40). Recheck echocardiogram on 5/15/16 revealed same changes as prior and a thrombus in her left ventricle. Medications/supplements included taurine 250mg PO BID, Mirtazepine 15mg tablets (Give 1/4 tablet PO every 3d PRN), Furosemide 12.5 mg tablets (Give 1/4 tablet PO SID), Pimobendan 1.5mg tiny tabs (Give 1 tablet PO BID). Patient presented on (b)(6) for partial aortic thromboembolism and owner's elected euthanasia.