New incident report
Incident Report Number: 2017-3430
Registrant Reference Number: US-BAYERBAH-2016-US0061127
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: UNKNOWN
PMRA Registration No. PMRA Submission No. EPA Registration No. 11556-152
Product Name: advantage II large cat
Liquid
Yes
Units: mL
Site: Animal / Usage sur un animal domestique
Animal's Owner
Cat / Chat
American Curl Shorthair
1
Female
6.5
15.8
lbs
Skin
>1 wk <=1 mo / > 1 sem < = 1 mois
<=30 min / <=30 min
System
Persisted until death
Yes
Yes
Unknown
Died
Treatment / Traitement
(eg. description of the frequency and severity of the symptoms
Immediately post application, the cat exhibited a behavior change of running around the house and hiding. Approximately 1 hours post application, the cat vomited once, then the vomiting resolved. She exhibited lethargy. On 21-Sep-2016, the cat developed application site alopecia, application site erythema, application site bleeding, application site mucopurulent discharge, application site pain and anorexia. On 23-Sep-2016, the cat exhibited application site scabbing. The anorexia resolved. She was not examined by a veterinarian and the remaining clinical signs continued. Follow up received on 8th Nov 2016: Immediately post application, the cat exhibited hyperactivity and hiding. Approximately 1 hours post application, the cat vomited once then exhibited lethargy. On 21-Sep-2016, the cat developed application site alopecia, application site erythema, application site bleeding, application site mucopurulent discharge, application site pain and anorexia. On 23-Sep-2016, the cat exhibited application site scabbing. The anorexia resolved; the other signs continued. On approximately 25 Sep 2016, the cat became lethargic and had a decreased appetite. On 27 Sep 2016, the cat had bloody stool outside the litter box. The cat was examined by a veterinarian and exhibited bruising and skin lesions on her lower abdominal/pelvic area. The cat was hospitalized; blood work was performed and reveled low packed cell volume (anemia), and decreased platelet count. A fecal was performed (results unknown). The veterinarian diagnosed plural effusion and ascites. A whole blood transfusion was performed, unspecified steroids and unspecified antibiotics were administered and the clinical signs continued. On 02 Oct 2016, the cat died. No known necropsy was performed. Follow up received on 8th Nov 2016: On approximately 25 Sep 2016, the cat had a decreased appetite.
Death
A behavioural response to product sensation or product smell may occur in particularly sensitive animals. Vomiting is an unspecific and may have many potential causes. Sign is not expected after topical product use and oral product uptake was not witnessed. Lethargy is likely consequence of vomiting. In individual cases, dermal reactions at the application site are possible in animals that are particularly sensitive. Would not expect application site bleeding, application site mucopurulent discharge and application site pain directly related to the product however, likely cat scratched or licked at site and caused skin lesions by self trauma. Self-trauma may have aggravated the application site reactions. Anorexia, lethargy and decreased appetite are likely associated with application site reactions. Bloody stools are neither expected nor inline with products pharmacotoxicological profile. Later diagnosed abnormal blood parameters, plural effusion and ascites are neither expected nor inline with products pharmaco-toxicological profile. 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. Time to onset is short for behavioural signs, vomiting and application site reactions, however it is long for other signs. Finally, even though some information (e.g. necropsy results) missing, considering the most prominent sign death which characterizes this case, no plausible connection can be made to the product and a product relation is deemed to be unlikely.