New incident report
Incident Report Number: 2019-3584
Registrant Reference Number: USA-BAYERBAH-2019-US0029444 (Report 571280)
Registrant Name (Full Legal Name no abbreviations): Bayer inc
Address: 2920 Matheson Blvd
City: Mississaugua
Prov / State: ON
Country: Canada
Postal Code: L4W 5R6
Domestic Animal
Country: UNITED STATES
Prov / State: MASSACHUSETTS
PMRA Registration No. PMRA Submission No. EPA Registration No. 11556-155
Product Name: Seresto collar Large dog
Other (specify)
COLLARYes
Other Units: COLLAR
Site: Animal / Usage sur un animal domestique
Medical Professional
Dog / Chien
Crossbred
1
Male
6
13.245
kg
Skin
>1 wk <=1 mo / > 1 sem < = 1 mois
>1 wk <=1 mo / > 1 sem < = 1 mois
System
Persisted until death
Yes
No
Died
Treatment / Traitement
(eg. description of the frequency and severity of the symptoms
On 05Jun2019, the dog had a seizure. On 06Jun2019, the dog was inappetent and lethargic; the owner removed the collar. The dog was examined by the veterinarian; bloodwork was performed and showed an elevated phosphorus, elevated blood urea nitrogen and dehydration. The dog was administered subcutaneous fluids and started on ondansetron. On 10 Jun 2019, the dog was treated with fluids, maropitant citrate, and dexamethasone injection. Prednisone and maropitant citrate were started and the dog was started on a gastrointestinal diet. On 15 Jun 2019, the dog exhibited dark tarry stools. Fecal analysis and giardia testing were negative. Sucralfate was re-filled. On 16 Jun 2019, stools were soft but did not contain blood. Vomiting recurred. On 18 Jun 2018, stools were dark. A vitamin and mineral supplement was started and sucralfate was refilled. On 27 Jun 2019, the dog was still inappetant and lethargic, vomiting again, had soft stool, and had lost 6 pounds. The owner had been giving the dog pumpkin beginning on an unknown date. Maropitant citrate was refilled and referral to specialty clinic for further diagnostics and treatment was advised but declined by the owner. On 29 Jun 2019, the dog died. Necropsy did not reveal any gross lesions.
Death
N - Unlikely The product is not anticipated to cause serious neurological disorders such as seizures after appropriate topical product administration as the controlled release mechanism assures release of only low doses of active ingredient at a time. But seizures were reported in connection with product use in dogs. However, it is known that overdose of 5 collars around the neck of adult dogs for an 8 months period and in 7 week old puppies for a 6 months period did not cause serious signs. This is supported by the extremely low systemic exposure with imidacloprid and flumethrin, particularly during the first week after application and also thereafter. Even with oral product exposure, seizures are not seen. Merely gastrointestinal signs may occur. Any action or treatment may trigger seizures in an animal with a respective disposition. Various etiologies exist for seizure events or paroxysmal signs, e.g. heart disorder, development disorder, metabolic disorder, infection, intoxication, idiopathic epilepsy, trauma, neoplasms. Time to onset is not suggestive of product involvement. Other causes are more probable. Reported inappentence and lethargy are unspecific and may have numerous other causes. Signs may occur initially after collar administration but are not expected to appear after long time. Additionally reported abnormal blood reports are not expected following appropriate topical product application as inconsistent with product's pharmacological profile. Collar was already removed at that time. Further, reported dehydration is not expected, either. Later reported digestive disorders are unspecific and may have numerous other causes (e.g. gastrointestinal infection, dietary incompatibility). Severe gastrointestinal signs (e.g. reported tarry stools) are not typically seen with product use. Weight loss is not expected and likely associated with the earlier described signs. Death is not expected following appropriate topical product application as inconsistent with product's pharmacological profile. Dog likely died due to ongoing signs. Necropsy, however, did not reveal any gross lesions. But time to onset is too long. Product involvement is considered unlikely.