New incident report
Incident Report Number: 2017-3273
Registrant Reference Number: USA-BAYERBAH-2015-US0063828
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: FLORIDA
PMRA Registration No. PMRA Submission No. EPA Registration No. 11556-151
Product Name: advantage II small cat
Other (specify)
Spot-on applicationYes
Units: mL
Site: Animal / Usage sur un animal domestique
No
Animal's Owner
Cat / Chat
Domestic Medium Hair
1
Female
13
1.814
kg
Skin
Unknown / Inconnu
>1 wk <=1 mo / > 1 sem < = 1 mois
System
>8 hrs <=24 hrs / > 8 h < = 24 h
No
No
Died
Treatment / Traitement
(eg. description of the frequency and severity of the symptoms
On 07-Dec-2015, an approximately 13 year old, 4 pound, neutered, female, Domestic Mediumhair feline, in unknown condition, with no known concomitant medical conditions, was administered 1 tube of Advantage II Small Cat (Imidacloprid-Pyriproxyfen) topically by the owner. On 20-Dec-2015, the cat had generalized pruritus, skin lesions, and alopecia. Approximately 12 hours post onset, the cat died while on the way to the veterinarian. It is not known if a necropsy was performed. The reporting party did not contact Bayer Animal Health to report the death of the animal but to inquire about product use on other felines. No further information is expected. This case is closed.
Death
N - Unlikely Pruritus and alopecia other than the application site are not anticipated with topical product administration. If any, skin reactions would be localized at the application site. Skin lesion may be consequence of pruritus. The information regarding the death of the cat was casually provided during an inquiry as the reporting party did not contact Bayer Animal Health to report the death of the animal but to inquire about product use on other felines. Nevertheless 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 642 mg/kg BW. 24-fold overdosage tolerated by cats without showing any side effect. Time to onset is exceptionally long. Numerous other causes are possible in a geriatric cat. Considering all available information even though it is unknown if necropsy was performed case is deemed to be unlikely.