New incident report
Incident Report Number: 2017-6938
Registrant Reference Number: USA-BAYERBAH-2017-US0060065 (Report 446521)
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: UNKNOWN
Unknown
PMRA Registration No. PMRA Submission No. EPA Registration No. Unknown
Product Name: Advantage II Spot-on pipette size unknown
Other (specify)
Spot-onYes
Unknown
Site: Animal / Usage sur un animal domestique
Unknown
Animal's Owner
Cat / Chat
Maine Coon
1
Male
17
Unknown
Skin
>1 wk <=1 mo / > 1 sem < = 1 mois
Unknown / Inconnu
System
Unknown / Inconnu
Unknown
Unknown
Died
Treatment / Traitement
(eg. description of the frequency and severity of the symptoms
On an unspecified date 2014, a 17 year old, neutered, male, Maine Coon Cat feline, of unknown weight and condition, with no known concomitant medical conditions, was administered 1 tube of Advantage II (cat-unspecified) (Imidacloprid-Pyriproxyfen) topically by the owner. On an unspecified date post application, in 2014, the cat developed twitching. Approximately 1 week post onset, in 2014, the cat recovered without medical intervention. On an unspecified date post recovery, in Sep 2016, the cat died. No necropsy was performed. The reporting party called to discuss the product and not to report the death of this animal. No further information is expected. This case is closed.
Death
N - Unlikely Reported twitching is not expected with appropriate topical product use. However unknown if applied dosage was according to label. No oral product exposure witnessed. Time to onset is unknown. Other potential causes are more probable. Death is not expected following appropriate topical product application as inconsistent with products pharmacological profile. 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. Time to onset for death is exceptionally long (approximately 2 years). Further the reporting party called to discuss the product and not to report the death of this geriatric animal. Overall, even though some information is missing (e.g. time to onset for initial twitching, necropsy details, etc.) and known safety profile of the product, sufficient information exists to rule out product relation completely.