New incident report
Incident Report Number: 2021-0353
Registrant Reference Number: USA-BAYERBAH-2020-US0062778 (Report 680869)
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: HAWAII
PMRA Registration No. PMRA Submission No. EPA Registration No. 11556-151
Product Name: advantageII small cat
PMRA Registration No. PMRA Submission No. EPA Registration No. 11556-152
Product Name: Advantage II Large Cat
Other (specify)
Spot-onYes
Units: mL
Site: Animal / Usage sur un animal domestique
No
Animal's Owner
Cat / Chat
Domestic Shorthair
1
Female
17
6.804
kg
Skin
>1 mo <= 6 mos / > 1 mois < = 6 mois
>1 wk <=1 mo / > 1 sem < = 1 mois
System
Unknown / Inconnu
No
No
Died
Treatment / Traitement
(eg. description of the frequency and severity of the symptoms
On approximately 10-Dec-2020, the cat developed lethargy, hind limb weakness, the behavior of not using the hind limbs, anorexia, adipsia, anuria, and intermittent emesis. The cat was not examined by the veterinarian, no treatments were performed, and the clinical signs continued. On 19-Dec-2020, the cat died. No necropsy was performed.
Death
Advantage II Small Cat: O - Unclassifiable/unassessable This is an off-label use of the product (low dose). Reported systemic and behavioural disorders are unspecific and may have numerous other causes. Intermittent emesis is not anticipated with appropriate topical product use. Oral ingestion of product was not observed. Even with oral product exposure sign would not be expected, but rather salivation. The time to onset is inconsistent and allows the exclusion of a product relation. Further, hind limb weakness, anuria and death are not expected after product application, as inconsistent with pharmaco-toxicological product profile. Oral exposure to the product is not expected to cause serious conditions leading to death either. The product was administered to puppies/kittens at up to 5 times the recommended dose, every 2 weeks for 6 treatments and there were no serious safety concerns. No signs of allergy/anaphylactic reaction which would have occurred in close proximity to product application. Additionally, previous exposure to the product was well tolerated. Time to onset is long in this case. No necropsy was performed. Other unrelated causes must be consider in this geriatric cat with unknown health status. Overall, a product relation is unassessable. advantage II large cat O - Unclassifiable/unassessable Reported systemic and behavioural disorders are unspecific and may have numerous other causes. Intermittent emesis is not anticipated with appropriate topical product use. Oral ingestion of product was not observed. Even with oral product exposure sign would not be expected, but rather salivation. The time to onset is inconsistent and allows the exclusion of a product relation. Further, hind limb weakness, anuria and death are not expected after product application, as inconsistent with pharmaco-toxicological product profile. Oral exposure to the product is not expected to cause serious conditions leading to death either. The product was administered to puppies/kittens at up to 5 times the recommended dose, every 2 weeks for 6 treatments and there were no serious safety concerns. No signs of allergy/anaphylactic reaction which would have occurred in close proximity to product application. Additionally, previous exposure to the product was well tolerated. Time to onset is long in this case. No necropsy was performed. Other unrelated causes must be consider in this geriatric cat with unknown health status. Overall, a product relation is unassessable.