New incident report
Incident Report Number: 2017-3268
Registrant Reference Number: USA-BAYERBAH-2015-US0061956
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: GEORGIA
Unknown
PMRA Registration No. PMRA Submission No. EPA Registration No. 11556-151
Product Name: Advantage II small cat
Liquid
Yes
Units: mL
Site: Animal / Usage sur un animal domestique
Animal's Owner
Cat / Chat
Domestic Shorthair
1
Female
9
3.18
kg
Skin
Unknown / Inconnu
Unknown / Inconnu
System
Persisted until death
Yes
No
Died
Treatment / Traitement
(eg. description of the frequency and severity of the symptoms
On approximately 4-Nov-2015, a 9 year old, 7 pound, neutered, female, Domestic Shorthair feline, in fair condition with a concomitant medical condition of fleas, was administered 1 tube of Advantage II Small Cat (Imidacloprid-Pyriproxyfen) topically by the owner. On an unspecified date post application, in approximately Nov 2015, the cat exhibited a behavior change. The cat was examined by a veterinarian and a blood profile showed low calcium level and anemia. On 4-Dec-2015, the product was reapplied. On 4-Dec-2015, approximately 6 hours post application, the cat was vocalizing, hypersalivating, kicking her hind legs (behavioral disorder NOS), and urinated on the couch (inappropriate urination). The cat was bathed in an unspecified type of liquid dish soap. On 6-Dec-2015 the cat started having seizures and died at home. A necropsy was not performed. Follow up received on 3rd Dec 2015: No further information is expected. Case is closed.
Death
N - Unlikely Reported behavioural change is unspecific and may have various other causes. Low calcium level and anemia are not expcted after product application as signs are not in line with pharmaco toxicological product profile. Time to onset is unknown in this case. Later observed behavioural signs may have occurred due to product sensation or smell. Time to onset is short. Hypersalivation after suspected ingestion of product. Sign is consistent with distaste reaction. 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. 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 seizures are not expected. Death is also not expected after product application, as inconsistent with pharmacotoxicological product profile. 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. Animal involved in this case was in fair condition. Though later reported behavioural signs are deemed to be product related, the more severe signs seizure and death are considered not product related, a product relation deemed to be unlikely.