New incident report
Incident Report Number: 2014-0392
Registrant Reference Number: 2014CK016
Registrant Name (Full Legal Name no abbreviations): Bayer Inc
Address: 77 Belfield Rd
City: Toronto
Prov / State: ON
Country: Canada
Postal Code: M9W 1G6
Domestic Animal
Country: UNITED STATES
Prov / State: UNKNOWN
PMRA Registration No. PMRA Submission No. EPA Registration No. 11556-130
Product Name: Advantage II Extra large dog
Liquid
Yes
Units: mL
Site: Animal / Usage sur un animal domestique
No
Animal's Owner
Cat / Chat
domestic short hair
1
Male
0.11
2.8
lbs
Skin
>1 wk <=1 mo / > 1 sem < = 1 mois
>2 hrs <=8 hrs / > 2 h < = 8 h
System
Unknown / Inconnu
Yes
No
Died
Treatment / Traitement
(eg. description of the frequency and severity of the symptoms
Approximately 4 hours following application, the feline began having severe tremors.. On 04 Sep 2013, the attending veterinarian examined the feline and found severe tremors. The feline was given an unknown amount of diazepam, but the tremors did not stop. Update 2013-10-10. This product is labeled for canines. Its use on a feline is off-label. Approximately 4 hours following application, the feline began having severe tremors. On 04 Sep 2013, the attending veterinarian examined the feline and found severe tremors. The feline was given an unknown amount of diazepam, but the tremors did not stop. The feline received no further treatment and died. No necropsy was performed. No further information is expected. This case is closed.
Death
Muscle tremor is not typically observed with appropriate topical product administration. Oral product exposure was not reported but might be assumed as other cats in household also had tremors (US-2013-185187//185235//185237). Assumable administration of an overdose in this young animal took place. However, death is not expected as inconsistent with pharmaco-toxicological product profile, even after overdose. 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. Product/active ingredients were shown to have no negative effect in kitten nursing treated cats. Short time to onset. Other etiologies in such a young cat are more likely e.g. infection. As time to onset short and no necropsy or further diagnostics available , a relation of fatal outcome with the product is unassessable