New incident report
Incident Report Number: 2018-3597
Registrant Reference Number: USA-BAYERBAH-2018-US0036772 (Report 502756)
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: CALIFORNIA
PMRA Registration No. PMRA Submission No. EPA Registration No. 11556-152
Product Name: Advantage II Large Cat
Other (specify)
spot onYes
Units: mL
Site: Animal / Usage sur un animal domestique
Animal's Owner
Cat / Chat
Domestic Shorthair
1
Female
14
6.35
kg
Skin
>1 wk <=1 mo / > 1 sem < = 1 mois
>8 hrs <=24 hrs / > 8 h < = 24 h
System
Persisted until death
Yes
No
Died
Treatment / Traitement
(eg. description of the frequency and severity of the symptoms
On 03-Jul-2018, the cat developed lethargy. On 05-Jul-2018, the cat developed application site erythema, application site alopecia, and a decreased appetite. On 09-Jul-2018, the cat has not been evaluated by a veterinarian and no treatments have been performed. The clinical signs continued. Follow up received on 12th July 2018: On 03-Jul-2018, the cat developed lethargy. On 05-Jul-2018, the cat developed application site erythema, application site alopecia, and a decreased appetite. On11-Jul-2018 the feline was evaluated by a veterinarian and placed on an unknown dose of prednisone. Overnight the feline passed away. No necropsy was performed. No further information is expected. This case is closed.
Death
O - Unclassifiable/unassessable Though lethargy is an unspecific sign and may have multiple potential other causes in an animal, it may represent a behavioural response to the product sensation. In individual cases, dermal reactions at the application site are possible in animals that are particular sensitive. Reported decrease appetite is rather unspecific but in this case it may be consequence of lethargic status. Further reported death is inconsistent with pharmaco-toxicological product profile and experience. 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, involved cat may have died due to old age (14 years). Though time to onset is consistent for initially reported signs but it is long for death. Other causes must be consider. Overall, considering all aspects, a product relation is deemed to be unassessable.