New incident report
Incident Report Number: 2017-7480
Registrant Reference Number: USA-BAYERBAH-2017-US0066638 (Report 452128)
Registrant Name (Full Legal Name no abbreviations): Bayer inc
Address: 2920 Matheson BLVD
City: Mississaugua
Prov / State: ON
Country: Canada
Postal Code: L5W5R6
Domestic Animal
Country: UNITED STATES
Prov / State: PENNSYLVANIA
PMRA Registration No. PMRA Submission No. EPA Registration No. 11556-151
Product Name: Advantage II Small Cat
Other (specify)
Spot-onYes
Units: mL
Site: Animal / Usage sur un animal domestique
Animal's Owner
Cat / Chat
Unknown
1
Female
21
2.722
kg
Skin
>1 wk <=1 mo / > 1 sem < = 1 mois
>1 wk <=1 mo / > 1 sem < = 1 mois
System
<=30 min / <=30 min
Unknown
Unknown
Died
Treatment / Traitement
(eg. description of the frequency and severity of the symptoms
On approximately 10-Sep-2017, a 21 year old, 6 pound, neutered, female, cat, of unknown breed and condition, with a concomitant medical condition of arthritis, was administered 1 tube of Advantage II Small Cat (Imidacloprid-Pyriproxyfen) via the topical route by the animal owner. On 07-Oct-2017, the cat exhibited difficulty walking, dragging the hind limbs and dies. No known necropsy was performed. No further information is expected; the case is closed. Note: The reporting party contacted Bayer Animal Health to inquire about product use and efficacy on another pet and not to report the death of this animal.
Death
N - Unlikely Reported walking difficulty and hind limb paralysis are not expected after from a toxicological point of view, neither imidacloprid nor pyriproxyfen does have the potential to provoke serious neurological signs in vertebrates. In case of oral ingestion of a considerable amount of product or after administration of an overdose shortly after product application, neurological symptoms such as tremor, ataxia, depression, miosis or mydriasis may occur. But paralysis is not expected. Walking difficulty may be associated with concomitant arthritis and paralysis. 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 not suggestive of product relation. Moreover, the reason for initial call was to inquire about product use and efficacy on another pet and not to report the death of this geriatric animal. Even though no necropsy is available, sufficient information exists to rule out product relation completely. Overall, a product relation consider as unlikely.