New incident report
Incident Report Number: 2017-4148
Registrant Reference Number: USA-BAYERBAH-2017-US0032101
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: TEXAS
PMRA Registration No. PMRA Submission No. EPA Registration No. 11556-152
Product Name: Advantage II Large Cat
Other (specify)
Spot-onYes
Unknown
Site: Animal / Usage sur un animal domestique
No
Animal's Owner
Cat / Chat
Domestic Shorthair
1
Male
6
4.082
kg
Skin
Unknown / Inconnu
>24 hrs <=3 days / >24 h <=3 jours
System
>1 wk <=1 mo / > 1 sem < = 1 mois
Unknown
Unknown
Died
Treatment / Traitement
(eg. description of the frequency and severity of the symptoms
On approximately 02-Apr-2017, a 6 year old, 9 pound, neutered, male, Domestic Shorthair cat, in unknown condition, with concomitant fleas, was administered 1 tube of Advantage II Large Cat (Imidacloprid-Pyriproxyfen) via the topical route by the animal owner. On approximately 04Apr2017 the cat developed lethargy. On approximately 14Apr2017 the cat was seen by a veterinarian. The cat was diagnosed with kidney failure and a liver disorder. On approximately 16Apr2017 the cat passed away. No necropsy was performed. No further information is expected. This case is closed.
Death
N - Unlikely Lethargy is an unspecific sign and may have multiple potential other causes in an animal. Sign may occur initially after product administration, but in this case time to onset is long. Later diagnosed kidney failure, liver disorders and death are not expected after product application, as inconsistent with pharmaco-toxicological product profile. No signs of allergy/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. Animal in this case likely died due to diagnosed liver and kidney disorders. Time to onset is also long. Other unrelated causes must be considered in this case. Even though some information is not available (animal health status and necropsy report), considering known safety profile of the product, a relation to the product consider as unlikely.