New incident report
Incident Report Number: 2017-3260
Registrant Reference Number: USA-BAYERBAH-2015-US0056277
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. 11556-151
Product Name: Advantage II Small Cat
Yes
Units: mL
Site: Animal / Usage sur un animal domestique
Animal's Owner
Cat / Chat
Domestic Shorthair
1
Male
8.5
3.402
kg
Skin
Unknown / Inconnu
<=30 min / <=30 min
System
>6 mos / > 6 mois
Yes
No
Died
Treatment / Traitement
(eg. description of the frequency and severity of the symptoms
On an unspecified date in approximately 2011, a 8.5 year old, 7.5 pound, neutered, male, Domestic Shorthair feline, in good condition, with no known concomitant medical conditions, was administered 1 tube of Advantage II Small Cat (Imidacloprid-Pyriproxyfen) topically by the owner. Approximately 10 minutes post application the cat fell over and was ataxic. The owner immediately bathed the cat with dish soap and the cat recovered within approximately 1 hour. The cat was not treated further with the product and died on an unspecified date in approximately 2013. No necropsy was performed. No further information is expected. This case is closed. The reason for the initial call was to discuss the use of our product on another animal, and not to report the death of the patient.
Death
N - Unlikely Falling and ataxia are typically observed with appropriate topical product administration. Product was used before without causing signs, an appropriate dosage was applied and no oral product exposure reported. Hence, other causes have to be considered. The reason for the initial call was to discuss the use of our product on another animal, and not to report the death of the patient. Nevertheless death is inconsistent with pharmaco-toxicological product profile and experience. 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. In case of suspected product involvement, adverse event would have been reported in close proximity and not long time after. Moreover, cat did not receive the product for two years prior to the death. Even though time to onset for initial signs is short it is exceptionally long for serious outcome. Finally, considering chronology of the signs and known product profile, a product relation is considered to be unlikely.