New incident report
Incident Report Number: 2020-5450
Registrant Reference Number: USA-BAYERBAH-2020-US0048185 (Report 665541)
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: NEW JERSEY
Unknown
PMRA Registration No. PMRA Submission No. EPA Registration No. 11556-155
Product Name: Seresto collar Cat
Other (specify)
COLLARYes
Other Units: COLLAR
Site: Animal / Usage sur un animal domestique
Animal's Owner
Cat / Chat
Unknown
1
Female
12
Unknown
Skin
Unknown / Inconnu
Unknown / Inconnu
System
Unknown / Inconnu
No
No
Died
Treatment / Traitement
(eg. description of the frequency and severity of the symptoms
On an unspecified date in approximately Jun-2020, the cat developed generalized pruritus, loose teeth and was bathed with liquid dish detergent. On an unspecified date in approximately Jul-2020, the cat was administered 1 international unit of unspecified insulin via the subcutaneous route by the animal owner. Approximately 12 hours later on an unspecified date in approximately Jul-2020, the cat began vocalizing, had a grand mal seizure, breathing difficulty and died.
Death
O - Unclassifiable/unassessable Pruritus on other than the application site is not typically seen with topical product administratio. Reported loose teeth is not expected after product application. However, the cat is a geriatric and diabetic patient, which may contribute to signs. The product is not anticipated to cause serious neurological disorders such as grand mal 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. Reported vocalisation and breathing difficulty may be associated with reported grand mal seizure. Further reported death is not expected following appropriate topical product application as inconsistent with product¿¿¿¿¿¿s pharmacological profile. Additionally the intent of the call was not to report this event but to raise questions concerning the product (e.g. mode of action) and apparently did not see a relation between product use and the sign reported. Although no necropsy performed, product involvement is not likely however due to limited information case is considered unassessable.