Dear Doctor: As a trained professional, you understand the loss of a pet is incredibly difficult. Every pet owner responds differently as they grieve. We believe the recent negative media coverage of Trifexis (spinosad + milbemycin oxime) is grounded in grief, but we cannot stand by idly while our reputation is disparaged. In a broadcast that aired in Atlanta late last year, WSB-TV featured three cases in which the reporter attempted to connect the dogs deaths to the use of Trifexis. There was no established link between Trifexis use and deaths, despite the reporter s repeated attempts to make that connection. Now, additional cases will be featured in a segment on the same station, by the same reporter, which continue to insinuate that Trifexis is linked to the cause of death of two pets. We vehemently disagree with the insinuation. The reporter is playing on the emotions of pet owners and discounting facts and science, despite our repeated efforts to educate him on the details related to Trifexis and the specific incidents we anticipate to be included in the report. We have included the details of these cases in the addendum. As you review, you will see there are complicating medical factors in both cases. Trifexis has been rigorously tested and approved as safe by the U.S. FDA, the European Medicines Agency and many other countries around the world to kill fleas and prevent infestations, to treat and control intestinal parasites and to prevent heartworm disease. Elanco has complete confidence in the safety and efficacy of Trifexis. Since the product came to market in January 2011, all reported potential adverse events have been reported to the FDA and appropriately investigated. There is no link established between product use and death. We apologize for the stress these disparaging reports have placed on you and your clinic. We thank you for your continued support of our products. As always, if you have additional questions or concerns, please contact our veterinary technical support team or your Elanco sales representative. Our sincerest thanks, Stephen A. Connell, DVM Director, Technical, Academic and Consumer Services Elanco Companion Animal Health (continued on page 2) 2014 Elanco CAH1814
Indications COMFORTIS kills fleas and is indicated for the prevention and treatment of flea infestations (Ctenocephalides felis), for one month, on dogs and puppies 14 weeks of age and older and 3.3 pounds of body weight or greater. Trifexis is indicated for the prevention of heartworm disease (Dirofilaria immitis). Trifexis kills fleas and is indicated for the prevention and treatment of flea infestations (Ctenocephalides felis), and the treatment and control of adult hookworm (Ancylostoma caninum), adult roundworm (Toxocara canis and Toxascaris leonina) and adult whipworm (Trichuris vulpis) infections in dogs and puppies 8 weeks of age or older and 5 pounds of body weight or greater. Important Safety Information Comfortis Dogs: The most common adverse reaction reported is vomiting. Other adverse reactions reported include lethargy, anorexia, ataxia, diarrhea, and seizures. Serious adverse reactions have been reported following concomitant extra-label use of ivermectin with Comfortis. Post-approval experience continues to support the safety of Comfortis when used concurrently with heartworm preventatives according to label directions. Use with caution in breeding females and dogs with pre-existing epilepsy. The safe use of Comfortis in breeding males has not been evaluated. Trifexis Serious adverse reactions have been reported following concomitant extra-label use of ivermectin with spinosad alone, one of the components of Trifexis. Treatment with fewer than three monthly doses after the last exposure to mosquitoes may not provide complete heartworm prevention. Prior to administration of Trifexis, dogs should be tested for existing heartworm infection. Use with caution in breeding females. The safe use of Trifexis in breeding males has not been evaluated. Use with caution in dogs with preexisting epilepsy. The most common adverse reactions reported are vomiting, lethargy, pruritus, and diarrhea. To ensure heartworm prevention, dogs should be observed for one hour after administration. If vomiting occurs within one hour, redose. Puppies less than 14 weeks of age may experience a higher rate of vomiting. For product labels, including complete safety information, see last pages.
ADDENDUM Elanco Case #1 1 Elanco Animal Health was initially contacted in September, 2011 by the attending animal hospital regarding a 7 year old, MN, Scottish Terrier weighing approximately 20#. The patient had been on Comfortis intermittently for flea control since 2009. Screening bloodwork, performed in Dec 2010, had revealed a slightly elevated alkaline phosphatase (ALP), but the owner declined additional workup at that time. In August of 2011, the dog had gained a couple of pounds and was started on the next higher dose of Comfortis. Following the August dose, the patient subsequently experienced a single episode of vomiting 30 minutes later, which stimulated the report to Elanco Animal Health. In November, 2012, the pet owner called Elanco to report that the same patient had been on the larger size of Comfortis since April, 2011 (earlier than reported by the clinic above) up to the most recent dose which had been administered on 30 October, 2012. In that time frame, the owner reported that the dog had experienced lethargy and nausea for one to one and half days post administration after each dose and that the dog recovered each time without medical intervention. During this contact, the pet owner also reported previously undisclosed medical information that the patient had pre-existing cerebellar atrophy that had been diagnosed in the 2004/2005 time frame and, as a result, the dog was on undisclosed natural remedies. It was also reported that the product smelled like medicine and the dog would not willingly take the tablets. In May, 2013, the previous vet clinic called in a report on the same patient again. A new case was created, as the report was related to the dog s first dose of Trifexis. Following dosing with Trifexis, the patient experienced two episodes of vomiting within 25 minutes of the dose, brief lethargy and ataxia and difficulty moving for 24 hours, but was reported to have recovered from there. Follow up information from the veterinary clinic in July, 2013 revealed that the pet owner came in to advise the staff that the dog had been doing poorly and subsequently taken to another veterinarian. A liver biopsy was reportedly done and showed severe liver damage. Elanco followed up with the pet owner and was advised of the following: The dog had been on a long term homemade diet (developed by a vet nutritionist) since 2008. Other supplements included fish oil, glucosamine & chondroitin, lion s mane mushroom in a capsule, and multivitamins. Additional contact with the attending clinic to follow up on the case indicated the dog was also on thyroid supplementation for hypothyroidism, was prescribed calcium supplementation, though it was unknown if owner had done that, and a liver biopsy performed in June had revealed cirrhosis of the liver, mild chronic hepatitis, biliary hyperplasia and vacuolar degeneration. Comments on the biopsy included that the cause of cirrhosis in chronic lesions was difficult to determine, but there was significant biliary hyperplasia that could indicate potential underlying gallbladder or bile duct disease. Progressive signs of hepatic failure should be anticipated. Additional medical conditions were also mentioned, including skin lesions, yeast infections and PD/PU that was originally evaluated at this clinic in April, 2013. In response to the news coverage anticipated regarding this case, these facts are provided to illustrate the multi-factorial nature of this patient s unfortunate condition, not to belittle their serious nature, or the stress endured by this pet, or his owners. While symptoms such as vomiting and lethargy postadministration are recognized potential side effects, Elanco s current assessment is that the pre-existing cerebellar disease and other identified issues, including severe liver cirrhosis, progressive liver failure, PD/PU and hypothyroidism, are related to one or more patient specific factors and/or etiologies unrelated to product administration.
Elanco Case 2 1 Elanco learned of this case in late July because of pending media activity related to the pet. The veterinarian did not believe there was an association between the problems encountered and Trifexis administration. The patient was a female, intact Bulldog born in September, 2012. She was started on Trifexis in January, 2013 at approximately four months of age. No issues with product administration occurred for the first several months following initiation of therapy. The history indicates the weight appropriate tablet was given in January and March (no February dose given), then due to puppy growth, the next size tablet appropriate for the patient was started in April and continued through September or early October. A grand mal seizure occurred in October and lab work performed as follow up was unremarkable. The timing of the initial seizure activity in relation to Trifexis administration was not known. The pet owner discontinued Trifexis following the occurrence of the seizure; however, the attending veterinarian did not attribute it to product administration. No treatment was initiated at that time. The patient experienced two seizures over the next two weeks. When presented for exam and scheduled vaccines, due to the additional seizure activity, phenobarbital tablets and diazepam for rectal administration were dispensed. An exam in November 2013, associated with scheduled influenza vaccination, was normal and the pet was reported as doing well. No further seizure activity was noted until January, 2014. Potassium bromide was dispensed at that time and phenobarbital blood levels were checked in mid-february and found to be in the expected therapeutic range. Seizure activity was reported as progressing from infrequent to more frequent and in March, 2014, therapy was switched to zonisamide. Diagnostics, including MRI and/or CT scan were discussed, but ultimately declined and in late March, the patient was humanely euthanized at the request of the pet owner. No necropsy was performed, but the veterinarian suspected a neurological issue as the most likely etiology for the progressive seizure activity in this case. 1 Data on file 2014 Elanco CAH1814