New incident report
Incident Report Number: 2016-3537
Registrant Reference Number: 2016KP020
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
PMRA Registration No. PMRA Submission No. EPA Registration No. 11556-151
Product Name: advantage II small cat
Liquid
Yes
Units: mL
Site: Animal / Usage sur un animal domestique
No
Other
Cat / Chat
Domestic Shorthair
1
Male
22
9
lbs
Skin
>1 wk <=1 mo / > 1 sem < = 1 mois
>1 wk <=1 mo / > 1 sem < = 1 mois
System
>1 mo and <= 2mos / >1 mois et < = 2mois
Yes
No
Died
Treatment / Traitement
(eg. description of the frequency and severity of the symptoms
On 10 Nov 2015, the cat exhibited weight loss. On 15 Nov 2015, the cat continued to lose weight, was examined by a veterinarian, and diagnosed with a abdominal tumor. The cat was placed on an unknown amount of oral buprenorphine as needed for pain. On 22 Dec 2015, the cat had anorexia. On 17 Jan 2016, the owner administered 2 doses of buprenorphine, sublingual. The cat died at home approximately 4 hours post administration of buprenorphine. No necropsy was performed. No more information is expected. This case is closed. Note: Previous application is well tolerated by the cat.
Death
Weight loss is not expected after product application as inconsistent with pharmaco toxicological product profile. In this case it may be related to later diagnose abdominal tumor. Anorexia is unspecific and may be related to the abdominal tumor. Abdominal tumor and death are also not expected after product application, as inconsistent with pharmaco-toxicological product profile. 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. Cat likely died due to underlying medical condition of abdominal tumor and of an old age. Additionally, previous exposure is well tolerated by the cat. Time to onset is long. Finally, even though some information (e.g. necropsy results) missing, considering known product profile and fetal outcome, a product involvement is deemed to be unlikely.