New incident report
Incident Report Number: 2013-3097
Registrant Reference Number: 2013AM097
Registrant Name (Full Legal Name no abbreviations): Bayer Inc
Address: 77 Belfield Rd
City: Toronto
Prov / State: ON
Country: Canada
Postal Code: M9W 1G6
Domestic Animal
Country: UNITED STATES
Prov / State: UNKNOWN
Unknown
PMRA Registration No. PMRA Submission No. EPA Registration No. 11556-128
Product Name: Advantage II Small dog
Liquid
Yes
Units: mL
Site: Animal / Usage sur un animal domestique
Animal's Owner
Dog / Chien
Maltese
1
Female
10
Unknown
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 01-Jan-2010 a 10 year old, unknown weight, spayed, female, Maltese canine, in good condition, with no known concomitant medical conditions, was administered 1 tube of Adavntage (dog unspecified) once topically by the owner. The owner continued to apply the product on an unknown basis yearly. On approximately 01-Mar-2010 the dog had difficulty breathing. The dog was examined by the veterinarian and diagnosed with Chronic obstructive pulmonary disease. The veterinarian prescribed an unknown dose of prednisone and an unknown dose of theophylline at that time. These treatments were used as needed. On 07-Nov-2012 the patient was administered an unknown amount of moxidectin injectable by the attending vet. On 15-Jan-2013 the dog was administered a distemper/parvo vaccination, a lepto vaccination, and a flu vaccination by the attending vet, and was prescribed neomycin/polymyxin B/dexamethasone drops to be applied to the eyes for conjunctivitis. The dog was also administered 1 tube of Advantage II Smal Dog (Imidacloprid-Pyrifroxyfen) once topically by the owner. On 16-Jan-2013 the dog was listless, vomiting, and had soft stool. The owner contacted the veterinarian who advised that the dog be examined but the owner declined. 2 hours later the owner contacted the veterinarian and adivsed that the dog was uncomfortable and again declined an exam. 3 hours later the owner called and advised bloody diarrhea and wanted to wait until the next morning to have her examined. On 17-Jan-2013 the dog was examined by the veterinarian. Radiographs showed a dense mass cranial to the right kidney and excess gas in the intra-intestinal area. A fecal was performed and was negative. 20 minutes later the dog collapsed with respiratory distress. The veterinarian administered .5cc of doxapram intramuscular and .3cc of epinephrine intramuscular. The dog was intubated. 5 minutes later the dog passed away. On gross necropsy performed by the veterinarian the dog was found to have hemorrhagic enteritis, an enlarged heart, and an adrenal gland tumor.
Death
Reported signs and fatal outcome not expected after topical application of Advantage, as inconsistent with pharmacotoxicological product profile and experience. Product has wide margin of safety. Oral LD50 in rat is 642 mg/kg BW. 20- fold overdosage tolerated by dogs without showing any side effect. Product used on animal before without causing any signs. Though time to onset appears close, chronology and prior health status of dog also argue against product relation. Necropsy revealed hemorrhagic enteritis, enlarged heart, and adrenal gland tumour. Finally, product relation can be completely excluded.