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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2021-0353

2. Registrant Information.

Registrant Reference Number: USA-BAYERBAH-2020-US0062778 (Report 680869)

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

3. Select the appropriate subform(s) for the incident.

Domestic Animal

4. Date registrant was first informed of the incident.

17-DEC-20

5. Location of incident.

Country: UNITED STATES

Prov / State: HAWAII

6. Date incident was first observed.

10-DEC-20

Product Description

7. a) Provide the active ingredient and, if available, the registration number and product name (include all tank mixes). If the product is not registered provide a submission number.

Active(s)

PMRA Registration No.       PMRA Submission No.       EPA Registration No. 11556-151

Product Name: advantageII small cat

  • Active Ingredient(s)
    • IMIDACLOPRID
      • Guarantee/concentration 9.1 %
    • PYRIPROXYFEN
      • Guarantee/concentration .46 %

PMRA Registration No.       PMRA Submission No.       EPA Registration No. 11556-152

Product Name: Advantage II Large Cat

  • Active Ingredient(s)
    • IMIDACLOPRID
      • Guarantee/concentration 9.1 %
    • PYRIPROXYFEN
      • Guarantee/concentration .46 %

7. b) Type of formulation.

Other (specify)

Spot-on

Application Information

8. Product was applied?

Yes

9. Application Rate.

.4

Units: mL

10. Site pesticide was applied to (select all that apply).

Site: Animal / Usage sur un animal domestique

11. Provide any additional information regarding application (how it was applied, amount applied, the size of the area treated etc).

On approximately 16-Nov-2020, a 17 year old, 15 pound, female, Domestic Shorthair cat, in unknown condition, with the concomitant medical condition of fleas, was administered 1 tube of Advantage II Small Cat (Imidacloprid-Pyriproxyfen) via the topical route by the animal owner. This was extra label use as a low dose. On approximately 15-Dec-2020, the cat was administered 1 tube of Advantage II Large Cat (Imidacloprid-Pyriproxyfen) topically by the owner.

To be determined by Registrant

12. In your opinion, was the product used according to the label instructions?

No

Subform III: Domestic Animal Incident Report

1. Source of Report

Animal's Owner

2. Type of animal affected

Cat / Chat

3. Breed

Domestic Shorthair

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

17

7. Weight (provide a range if necessary )

6.804

kg

8. Route(s) of exposure

Skin

9. What was the length of exposure?

>1 mo <= 6 mos / > 1 mois < = 6 mois

10. Time between exposure and onset of symptoms

>1 wk <=1 mo / > 1 sem < = 1 mois

11. List all symptoms

System

  • General
    • Symptom - Lethargy
  • Gastrointestinal System
    • Symptom - Anorexia
    • Symptom - Vomiting
  • Nervous and Muscular Systems
    • Symptom - Difficulty walking
  • Renal System
    • Symptom - Anuria
  • General
    • Symptom - Other
    • Specify - the behavior of not using the hind limbs
    • Symptom - Adipsia
    • Symptom - Death
    • Symptom - Weakness
    • Specify - hind limb weakness

12. How long did the symptoms last?

Unknown / Inconnu

13. Was medical treatment provided? Provide details in question 17.

No

14. a) Was the animal hospitalized?

No

14. b) How long was the animal hospitalized?

15. Outcome of the incident

Died

16. How was the animal exposed?

Treatment / Traitement

17. Provide any additional details about the incident

(eg. description of the frequency and severity of the symptoms

On approximately 10-Dec-2020, the cat developed lethargy, hind limb weakness, the behavior of not using the hind limbs, anorexia, adipsia, anuria, and intermittent emesis. The cat was not examined by the veterinarian, no treatments were performed, and the clinical signs continued. On 19-Dec-2020, the cat died. No necropsy was performed.


To be determined by Registrant

18. Severity classification (if there is more than 1 possible classification

Death

19. Provide supplemental information here

Advantage II Small Cat: O - Unclassifiable/unassessable This is an off-label use of the product (low dose). Reported systemic and behavioural disorders are unspecific and may have numerous other causes. Intermittent emesis is not anticipated with appropriate topical product use. Oral ingestion of product was not observed. Even with oral product exposure sign would not be expected, but rather salivation. The time to onset is inconsistent and allows the exclusion of a product relation. Further, hind limb weakness, anuria and death are not expected after product application, as inconsistent with pharmaco-toxicological product profile. Oral exposure to the product is not expected to cause serious conditions leading to death either. The product was administered to puppies/kittens at up to 5 times the recommended dose, every 2 weeks for 6 treatments and there were no serious safety concerns. No signs of allergy/anaphylactic reaction which would have occurred in close proximity to product application. Additionally, previous exposure to the product was well tolerated. Time to onset is long in this case. No necropsy was performed. Other unrelated causes must be consider in this geriatric cat with unknown health status. Overall, a product relation is unassessable. advantage II large cat O - Unclassifiable/unassessable Reported systemic and behavioural disorders are unspecific and may have numerous other causes. Intermittent emesis is not anticipated with appropriate topical product use. Oral ingestion of product was not observed. Even with oral product exposure sign would not be expected, but rather salivation. The time to onset is inconsistent and allows the exclusion of a product relation. Further, hind limb weakness, anuria and death are not expected after product application, as inconsistent with pharmaco-toxicological product profile. Oral exposure to the product is not expected to cause serious conditions leading to death either. The product was administered to puppies/kittens at up to 5 times the recommended dose, every 2 weeks for 6 treatments and there were no serious safety concerns. No signs of allergy/anaphylactic reaction which would have occurred in close proximity to product application. Additionally, previous exposure to the product was well tolerated. Time to onset is long in this case. No necropsy was performed. Other unrelated causes must be consider in this geriatric cat with unknown health status. Overall, a product relation is unassessable.