New incident report
Incident Report Number: 2017-4035
Registrant Reference Number: USA-BAYERBAH-2017-US0012580
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: UNKNOWN
Unknown
PMRA Registration No. PMRA Submission No. EPA Registration No. 11556-151
Product Name: advantage II small cat
Other (specify)
Spot-onYes
Units: mL
Site: Animal / Usage sur un animal domestique
Unknown
Animal's Owner
Cat / Chat
Unknown
1
Female
15
Unknown
Skin
Unknown / Inconnu
Unknown / Inconnu
System
Unknown / Inconnu
Unknown
Unknown
Died
Treatment / Traitement
(eg. description of the frequency and severity of the symptoms
On an unspecified date in approximately 2015, a 15 year old, female, feline of unknown signalment and condition, with no known concomitant medical conditions, was administered 1 tube of Advantage II Small Cat (Imidacloprid-Pyriproxyfen) topically by the owner. On an unspecified date post application in approximately 2015, the cat was administered an unknown dose of selmectin topically monthly. On an unspecified date in approximately 2015, the cat exhibited intermittent seizures. It was unknown if medical intervention was sought. On 29Mar2016, the cat died. No necropsy was performed. The reason for the initial phone call was to discuss the expiration date of the product and not to report the death of the patient. Due to the sensitive nature of the communication, specific relevant event details were not obtained, nor will such be sought. No further information is expected and this case is closed.
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. Further, death is not expected after product application, as inconsistent with pharmaco-toxicological product profile. The information regarding the death of this geriatric cat was casually provided during an inquiry, the caller contacted Bayer Animal Health to discuss the expiration date of the product and not to report the death of the patient. Product has wide margin of safety. Time to onset for death is long. Finally, even though some information missing (e.g. time to onset for initial sign, necropsy details), considering known product profile and unexpected fatal outcome, a product involvement is deemed to be unlikely