New incident report
Incident Report Number: 2015-6139
Registrant Reference Number: 2015KP256
Registrant Name (Full Legal Name no abbreviations): Bayer Inc
Address: 2920 Matheson Blvd. East
City: Mississauga
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. 11556-152
Product Name: Advantage II Large cat
Liquid
Yes
Units: mL
Site: Animal / Usage sur un animal domestique
Unknown
Other
Cat / Chat
Domestic Shorthair
1
Male
13.5
Unknown
Skin
>1 wk <=1 mo / > 1 sem < = 1 mois
Unknown / Inconnu
System
Unknown / Inconnu
Yes
Yes
2
Day(s) / Jour(s)
Died
Treatment / Traitement
(eg. description of the frequency and severity of the symptoms
On an unspecified date post application, in 2014, the cat exhibited weight loss. The product was re-applied on an unknown frequency with the last application on 30 Jul 2015. The cat weighed 9.2 pounds at that time. On 31 Jul 2015, the cat was lethargic and ataxic. The cat was examined by the emergency veterinarian; radiographs showed a growth in the abdomen and metastasis to the lungs. The cat was hospitalized at the emergency clinic where they had to resuscitate it on 01-Aug-2015 and on 02-Aug-2015. On 02 Aug 2015, the cat was released feeling better but not fully recovered. On 03 Aug 2015, the cat started to gradually get weaker/lethargy. On 05 Aug 2015, the cat died. Necropsy was not performed. No more information is expected. The case is closed.
Death
Reported weight loss is not related to the product after the exceptional long time to onset (more than four months). Though time to onset is short for lethargy and ataxia reported on subsequent application, they may rather be related to the medical history and diagnosed metastatis. Growth in the abdomen, metastasis to the lungs and death are inconsistent with pharmacotoxicological product profile. This cat was in poor condition, with concomitant medical conditions of small cell lymphoma and low white blood cell count, being treated with an unspecified dose of chlorambucil. These factors more likely lead to the clinical signs and ultimate outcome of the patient. The product itself has no carcinogen potential. Even though necropsy is not performed considering serious outcome, a product connection is deemed to be unlikely.