New incident report
Incident Report Number: 2020-5440
Registrant Reference Number: USA-BAYERBAH-2020-US0045541 (Report 662669)
Registrant Name (Full Legal Name no abbreviations): Elanco
Address: 150 Research Lane, Suite 120
City: Guelph
Prov / State: ON
Country: Canada
Postal Code: N1G 4T2
Domestic Animal
Country: UNITED STATES
Prov / State: KANSAS
PMRA Registration No. PMRA Submission No. EPA Registration No. 11556-155
Product Name: Seresto collar Large
Other (specify)
COLLARYes
Other Units: COLLAR
Site: Animal / Usage sur un animal domestique
Medical Professional
Dog / Chien
Mastiff
1
Male
0.41
30.799
kg
Skin
>3 days <=1 wk / >3 jours <=1 sem
>8 hrs <=24 hrs / > 8 h < = 24 h
System
Persisted until death
Yes
No
Died
Treatment / Traitement
(eg. description of the frequency and severity of the symptoms
On 29Aug2020, the concomitant stiffness worsened and the dog was lethargic. The dog was administered 0.5 tablet of naproxen sodium by the owner. On 30Aug2020, the dog refused to walk and had limb pain during palpation. The dog was administered two unspecified doses of acetylsalicylic by the owner. On 31Aug2020, the dog was evaluated by a veterinarian, was laterally recumbent and had a fever of 104. Bloodwork performed revealed elevated white blood cells (27,000), elevated alanine transaminase (4495), elevated Creatine phosphokinase (143452), elevated urine specific gravity (1068), and elevated blood urea nitrogen (30). Thoracic radiographs performed were within normal limits. A urinary catheter was placed and the dog's urine was extremely dark, had occult bilirubin and blood. The dog was diagnosed with myoglobinuria and myositis of unknown origin. The dog went in to respiratory distress and was taken home against medical advise. On 01Sep2020, the dog died. No necropsy was performed.
Death
O - Unclassifiable/unassessable Worsening of concomitant muscle stiffness is not expected following appropriate topical product application. Lethargy, refused to walk and limb pain on palpation, lateral recumbency are likely associated with muscle stiffness and later diagnosed myositis. Fever is unspecific and likely associated with musculoskeletal disorders and elevated white blood cells. Furthermore, abnormal blood and urine parameters, diagnosed myoglobinuria, myositis, respiratory distress and death are not expected following appropriate topical product application as inconsistent with product¿¿¿¿¿¿s pharmacological profile. Oral exposure to the collar is not expected to cause serious sign either. An overdose of 5 collars around the neck was investigated in adult cats and dogs for an 8 months period and in 10 week old kittens and 7 week old puppies for a 6 months period without causing serious signs. This is supported by the extremely low systemic exposure with imidacloprid and flumethrin, particularly during the first week after application and also thereafter. No sign of anaphylaxis reported which would have occurred in close proximity to the collar application. Animal may have died due to earlier described signs. No necropsy performed. Although time to onset is short, other unrelated causes must be consider. Overall, a product relation for the is unassessable.