New incident report
Incident Report Number: 2017-0687
Registrant Reference Number: 2017KP009
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. 11556-152
Product Name: advantage II large cat
Liquid
Yes
Units: mL
Site: Animal / Usage sur un animal domestique
Animal's Owner
Cat / Chat
Unknown
1
Male
8
15.9
lbs
Skin
>1 wk <=1 mo / > 1 sem < = 1 mois
>1 wk <=1 mo / > 1 sem < = 1 mois
System
Unknown / Inconnu
No
No
Died
Treatment / Traitement
(eg. description of the frequency and severity of the symptoms
On 27Sep2016, the cat died. No necropsy was performed. No more information is expected and the case is closed. NOTE: This product has been used previously in this cat without issues. Follow up received on 12 Oct 2016: On 26-Sep-2016 the cat was hyperactive. On 27-Sep-2016 the cat had a seizure, was hypersalivating and died. A necropsy was not performed. No more information is expected and the case is closed. Follow up received on 12 Oct 2016: On 17-Sep-2016, an 8 year old, 15.9 pound, male, feline, of an unknown breed and reproductive status, in unknown condition, with no known concomitant medical conditions, was administered 1 tube of Advantage II Large Cat (Imidacloprid-Pyriproxyfen) topically by the owner.
Death
Serious nervous system disorders such as seizures are not anticipated with topical use of Advantage as not consistent with its pharmacological/toxicological product profile. The application procedure and associated stress may trigger seizures in animals with a respective disposition. But that may occur with any other product. Other reported signs of hyperactivity and hypersalivation likely related to reported seizures. Death not expected after product application, as inconsistent with pharmacotoxicological product profile. 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. Also, product had been used before without causing any signs. However, time to onset (about 2 weeks) is much Long. Considering all these aspects, although some information missing (e.g. medical history of animal, no necropsy), product relation is deemed to be unlikely.