New incident report
Incident Report Number: 2017-2159
Registrant Reference Number: 2017KP104
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
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
Russian Blue
1
Male
20
15
lbs
Skin
>1 wk <=1 mo / > 1 sem < = 1 mois
>1 wk <=1 mo / > 1 sem < = 1 mois
System
>1 mo and <= 2mos / >1 mois et < = 2mois
Yes
No
Died
Treatment / Traitement
(eg. description of the frequency and severity of the symptoms
On an unspecified date post application, in approximately Feb-2017, the cat exhibited pruritus. On 09-Feb-2017, the owner administered 1 tube of Advantage II Large Cat (Imidacloprid-Pyriproxyfen) topically. Approximately 40 minutes post application, the cat exhibited loose stools, 4 episodes of vomiting, and lethargy. The owner wiped the application site with dish soap and water, but the cat was not examined by a veterinarian and the clinical signs continued. Follow-up received on 24th Mar 2017: On an unknown date in approximately Jan2017, a 20 year old, approximately 15 pound, neutered, male, Russian Blue feline, in unknown condition, with concomitant skin allergies, was administered 1 tube of Advantage II Large Cat (Imidacloprid-Pyriproxyfen) topically by the owner. On an unspecified date post application, in approximately Feb-2017, the cat exhibited pruritus. On 23-Feb-2017, the owner administered 1 tube of Advantage II Large Cat (Imidacloprid-Pyriproxyfen) topically. Approximately 6 hours post application, the cat exhibited loose stools, 4 episodes of vomiting, lethargy, and dilated pupils; the owner washed the application site with dish soap and water. On 24 Feb 2017, the cat exhibited abnormal behavior. The cat was seen by the veterinarian, weighed 7 pounds, was diagnosed with hypertension, and administered intravenous fluids. On 26 Feb 2017, the cat was re-examined by the veterinarian and administered unspecified antibiotic and unspecified blood pressure medication. On approximately 28Feb2017, the feline died; no necropsy was performed.
Death
Reported pruritus on other than the application site is not anticipated with topical product administration. If any, skin reaction would be localized at the application site. Time to onset unknown. Other causes (concomitant history of skin allergies) should be considered. Later reported loose stools, vomiting, and lethargy are unspecific and may have many potential causes. Time to onset short, though. Oral product uptake was not witnessed. Even with oral product exposure sign would not be expected, but rather salivation. Dilated pupils are not expected with appropriate topical product use. Weight loss, diagnosed hypertension and later reported death are not expected after topical product application as 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. The cat was very old (20 years old), thus underlying age-related medical problems are quite likely. Some information (e.g. health status and necropsy results) is not available. Neverthless, considering the products pharmacological profile, a relation is considered unlikely, but due to limited information, the case was considered as unassessable.