New incident report
Incident Report Number: 2021-2441
Registrant Reference Number: USA-BAYERBAH-2021-US0010349 (Report 691955)
Registrant Name (Full Legal Name no abbreviations): Elanco
Address: 150 Research Lane, Suite 120
City: Guelph
Prov / State: ON
Country: Canada
Postal Code: N1G 4T2
Domestic Animal
Country: UNITED STATES
Prov / State: UNKNOWN
Unknown
PMRA Registration No. PMRA Submission No. EPA Registration No. 11556-155
Product Name: Seresto large dog
Other (specify)
COLLARYes
Other Units: COLLAR
Site: Animal / Usage sur un animal domestique
Animal's Owner
Dog / Chien
Cattle Dog - Australian (Blue/Red Heeler, Queensland)
1
Male
12
20.412
kg
Skin
>1 mo <= 6 mos / > 1 mois < = 6 mois
>1 mo <=2 mos / > 1 mois < = 2 mois
System
Unknown / Inconnu
Unknown
Unknown
Died
Treatment / Traitement
(eg. description of the frequency and severity of the symptoms
On approximately 06-Mar-2021, the dog developed tremors, ataxia, and a seizure. On 07-Mar-2021, the dog died. No necropsy was performed. Due the sensitive nature of the communication, certain pertinent information was not obtained, nor will be sought. No further information is expected. This case is closed.
Death
O - Unclassifiable/unassessable The product is not anticipated to cause serious neurological disorders such as seizure 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 not suggestive of product involvement. Other causes are more probable in this geriatric dog with unknown health condition. Additionally, reported neurological signs like tremors and ataxia are not typically seen with appropriate topical product administration. However, in this case, they are likely associated with seizures. Later reported death is not expected following appropriate topical product application as inconsistent with products pharmacological profile. No signs of anaphylaxis reported which would have occurred in close proximity to the collar application. Time to onset is long. Outcome may be consequence of alternative causes (seizures) in this geriatric dog. However, considering some information is missing (such as unknown health status, medical history and necropsy details is unknown), a relation to case is unassessable.