New incident report
Incident Report Number: 2015-6154
Registrant Reference Number: 2015KP270
Registrant Name (Full Legal Name no abbreviations): Bayer Inc
Address: 2920 Matheson Blvd. East
City: Mississauga
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. 11556-130
Product Name: Advantage II Extra Large dog
Liquid
Yes
Units: mL
Site: Animal / Usage sur un animal domestique
Unknown
Other
Dog / Chien
unknown
1
Unknown
Unknown
Unknown
Skin
>1 wk <=1 mo / > 1 sem < = 1 mois
Unknown / Inconnu
System
Unknown / Inconnu
No
No
Died
Treatment / Traitement
(eg. description of the frequency and severity of the symptoms
On an unspecified date post application, in approximately 2014, the dog had a seizure. One day post seizure, the dog had another seizure and was examined by the veterinarian; no known treatments were provided. One week post exam, the dog had a cluster seizure. The dog was examined by the veterinarian and started on an unknown medication. The dog died approximately 4 hours post administration of the medication. No necropsy was performed. The reason for the initial call was to discuss the use of our product for an active flea infestation on another animal, and not to report the death of the patient. No further information is expected this case is closed.
Death
Serious nervous system disorders such as seizures are not anticipated with topical administration of Advantage II. From a toxicological point of view, neither imidacloprid nor pyriproxyfen does have the potential to provoke seizures in vertebrates. Death is inconsistent with pharmacotoxicological product profile and experience. Product has wide margin of safety. Oral LD50 in rat 642 mg/kg BW. 20-fold overdosage tolerated by dogs without showing any side effect. Moreover death of the animal occurred after administration of the unknown medication. The dog involved in this case was geriatric. In case of suspected product involvement, adverse event would have been reported in close proximity and not long time after. The reason for the initial call was to discuss the use of product for an active flea infestation on another animal, and not to report the death of the patient. Even though some information is not available (e.g. necropsy report and time to onset), sufficient information exists to ruled out product involvement. Finally, a product relation considered as unlikely.