New incident report
Incident Report Number: 2018-1608
Registrant Reference Number: USA-BAYERBAH-2018-US0007401 (Report 473374)
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. 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
Female
Unknown
Unknown
Skin
Unknown / Inconnu
<=30 min / <=30 min
System
Unknown / Inconnu
Unknown
Unknown
Died
Treatment / Traitement
(eg. description of the frequency and severity of the symptoms
Approximately 1 minute post administration, the cat developed lethargy. Approximately 24 hours post administration, the lethargy resolved. On an unknown date post administration in approximately 2012, the cat developed diabetes. It was unknown if treatments or exams were performed. On an unknown date post administration in approximately 2012, the cat died. No necropsy was performed. Due to the sensitive nature of the communication, specific relevant event details were not obtained, nor will such be sought. The reason for the initial call was to discuss the use of the product in the owners current cats and not to report the death of the patient. No further information is expected. This case is closed.
Death
N-Unlikely: Reported lethargy may be a behavioural response to the product sensation or to the product smell. Reported diabetes and death are not expected following appropriate topical product application as inconsistent with product's pharmacological profile. 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. In case of suspected product involvement, adverse event would have been reported in close proximity and not long time (6 years) after. Further, the owner did not believe in product involvement either as the reason for the initial call was to discuss the use of the product in the owner's current cats and not to report the death of the patient. Time to onset is consistent for initially reported lethargy but it is unknown for later reported adverse events. Despite of necropsy is not available, a product relation is consider as unlikely.