New incident report
Incident Report Number: 2014-0399
Registrant Reference Number: 2014CK023
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
Unknown
PMRA Registration No. PMRA Submission No. EPA Registration No. Unknown
Product Name: Advantage II (unknown)
Liquid
Yes
Units: mL
Site: Animal / Usage sur un animal domestique
No
Animal's Owner
Cat / Chat
domestic short hair
1
Female
13
6
lbs
Skin
>1 wk <=1 mo / > 1 sem < = 1 mois
>8 hrs <=24 hrs / > 8 h < = 24 h
System
>8 hrs <=24 hrs / > 8 h < = 24 h
Yes
Unknown
Died
Treatment / Traitement
(eg. description of the frequency and severity of the symptoms
On an unspecified date, approximately 1 day post application, the cat began having seizures. The cat was seen by a veterinarian and unknown treatments were performed. On approximately 16 Oct 2013 the cat passed away. It is not known if a necropsy was performed. Update 2013-11-08: Immediately after product application the cat ran away. This behavior resolved within 10 minutes. An undetermined amount of time later the cat developed pruritus. Fleas were visible on the pet.The product was applied monthly (partial tube) from Nov 2012 thru Jan 2013 and the cat continued to have pruritus. On an unspecified date after the product was applied on 13 Feb 2013 the cat became blind. A cause for the vision loss was not determined. Continued partial tube product applications occurred from March 2013 thru 13 Sept 2013. The cat continued to have pruritus.On 06 Oct 2013 a partial tube of product was applied.On 16 Oct 2013 the seemed disoriented, anorexic and had one episode of vomiting.On 17 Oct 2013 the cat had a behavioral change going from episodes of hyperactivity to reluctancy to move. The cat then began paddling. Due to the clinical signs the cat was seen by the attending veterinarian. Unknown diagnostics and blood work were performed and revlealed the cat was hypokalemic. Unknown treatments were initiated and the cat began to improve on 18 Oct 2013; however later that day the cat began paddling again and shortly after passed away. No necropsy was performed. The attending veterinarian was suspicious this cat had an undiagnosed neoplasia.
Death
Seizures and death are inconsistent with pharmacotoxicological product profile and experience and therefore not expected. Time to onset time with 10 days too long. 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. Neither signs, nor time to onset nor chronology consistent with pharmaco-toxicological product proile. Previous exposure with no adverse reaction for already more than one year. The underlying cause of death of this cat was more likely due to an undiagnosed neoplasia according to case description as no necropsy was performed. Other medical problems also more likely in geriatric cat as indicated by hypokalemia which is probable cause for neurological signs. Based on the toxicological profile and inconsistent chronology a product relation is considered unlikely.