New incident report
Incident Report Number: 2017-6457
Registrant Reference Number: USA-BAYERBAH-2017-US0055185 (Report 441896)
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: CALIFORNIA
Unknown
PMRA Registration No. PMRA Submission No. EPA Registration No. Unknown
Product Name: Advantage (cat-unspecified)
Other (specify)
Spot-onYes
Unknown
Site: Animal / Usage sur un animal domestique
Unknown
Animal's Owner
Cat / Chat
Unknown
1
Unknown
15
Unknown
Skin
>15 min <=2 hrs / >15 min <=2 h
>30 min <=2 hrs / >30 min <=2 h
System
>30 min <=2 hrs / >30 min <=2 h
Unknown
Unknown
Died
Treatment / Traitement
(eg. description of the frequency and severity of the symptoms
Approximately 1 hour post application, the cat exhibited a seizure then died. No necropsy was performed.
Death
N-Unlikely: Serious nervous system disorders such as seizures are not anticipated with topical administration of Advantage II. From a toxicological point of view, neither imidacloprid nor pyriproxyfen does have the potential to provoke seizures in vertebrates. In case of oral ingestion of a considerable amount of product or after administration of an overdose shortly after product application, neurological symptoms such as tremor, ataxia, depression, miosis or mydriasis may occur. But seizures are not expected. Unknown whether seizures were confirmed by vet or only observed by owner. Death is inconsistent with pharmaco-toxicological product profile and experience. No signs of allergic/anaphylactic reaction reported. Product has wide margin of safety. Oral LD50 in rat is 642 mg/kg BW. 24-fold overdosage tolerated by cats without showing any side effect. The involved animal was geriatric. Moreover, the caller contacted Bayer Animal Health to inquire about a new pet in the household and not to report this event. In case of suspected product involvement, adverse event would have been reported in close proximity and not long time after (approximately 8 years). In the end, even though time to onset is short and no necropsy was performed, considering all aspects and unexpected serious outcome, a product involvement is deemed to be unlikely. The caller contacted Bayer Animal Health to inquire about a new pet in the household and not to report this event.