New incident report
Incident Report Number: 2017-6942
Registrant Reference Number: USA-BAYERBAH-2017-US0060956 (Report 447010)
Registrant Name (Full Legal Name no abbreviations): Bayer inc
Address: 2920 Matheson BLVD
City: Mississaugua
Prov / State: ON
Country: Canada
Postal Code: L5W5R6
Domestic Animal
Country: UNITED STATES
Prov / State: NEW YORK
PMRA Registration No. PMRA Submission No. EPA Registration No. 11556-151
Product Name: Advantage II Small Cat
Other (specify)
Spot-onYes
Units: mL
Site: Animal / Usage sur un animal domestique
No
Animal's Owner
Cat / Chat
Birman (Sacred Birman)
1
Male
16
4.536
kg
Skin
>8 hrs <= 24 hrs / >8 h <= 24 h
>8 hrs <=24 hrs / > 8 h < = 24 h
System
Unknown / Inconnu
Unknown
Yes
Unknown
Died
Treatment / Traitement
(eg. description of the frequency and severity of the symptoms
On 22-Aug-2017, a 16 year old, approximately 10 pound, neutered, male, Birman (Sacred Birman) cat, in unknown condition, with a concomitant medical condition of fleas, was administered a partial tube of Advantage II Small Cat (Imidacloprid-Pyriproxyfen) via the topical route by the animal owner. This product is not labeled for partial tube application, nor is it labeled for application on cats weighing more than 9 pounds. On 23-Aug-2017, the cat exhibited multiple seizure episodes. The cat was examined by a veterinarian who hospitalized the cat for continued observation and the cat died. No necropsy was performed. No further information is expected; the case is closed. On Aug 2017 the cat was also administered unknown of via the unknown route by the animal owner.
Death
O - Unclassifiable/unassessable Serious nervous system disorders such as seizures are not anticipated with topical administration of Advantage II. From a toxicological point of view, neither imidacloprid nor pyriproxyfen does have the potential to provoke seizures in vertebrates. No oral product exposure is reported. 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 is 642 mg/kg BW. 24-fold overdosage tolerated by cats without showing any side effect. In this case, a tool low dose of product was applied which makes product involvement even more unlikely. Involved animal was geriatric, thus other underlying conditions must be considered. Time to onset is short, though. Finally, a product involvement is considered as unassessable.