New incident report
Incident Report Number: 2019-5077
Registrant Reference Number: USA-BAYERBAH-2019-US0045981 (Report 588597)
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: NEW YORK
Unknown
PMRA Registration No. PMRA Submission No. EPA Registration No. Unknown
Product Name: Advantage II (cat-unspecified)
Other (specify)
spot-onYes
Unknown
Site: Animal / Usage sur un animal domestique
Unknown
Animal's Owner
Cat / Chat
unknown
1
Unknown
Unknown
Unknown
Skin
>1 wk <=1 mo / > 1 sem < = 1 mois
Unknown / Inconnu
System
Unknown / Inconnu
Unknown
Unknown
Died
Treatment / Traitement
(eg. description of the frequency and severity of the symptoms
In approximately Aug-2013, post administration, the cat exhibited seizures and hypersalivation. The feline was evaluated by a veterinarian and unknown diagnostics and treatments were provided. On an unknown date in approximately Aug-2013, the seizures and hypersalivation resolved. On an unknown date in approximately 2017, the cat died. No necropsy was performed.
Death
Serious nervous system disorders such as seizures are not anticipated with topical administration of product. 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. Various etiologies exist for seizure events or paroxysmal signs, e.g. heart disorder, development disorder, metabolic disorder, infection, intoxication, idiopathic epilepsy, trauma, neoplasms. Hypersalivation likely associated with seizures. 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 unknown for initial reported seizures and long for death. Considering low level of information (e.g. animal details, health status, medical history and necropsy details are unknown), a relation to this case is considered as unassessable.