New incident report
Incident Report Number: 2016-2741
Registrant Reference Number: 2016KP059
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: UNKNOWN
PMRA Registration No. PMRA Submission No. EPA Registration No. 11556-155
Product Name: Seresto Collar - Unknown
Other (specify)
CollarYes
Other Units: collar
Site: Animal / Usage sur un animal domestique
Unknown
Other
Dog / Chien
Pug
1
Male
1.3
23
lbs
Skin
>1 wk <=1 mo / > 1 sem < = 1 mois
>2 mos <=6 mos / > 2 mois < = 6 mois
System
>24 hrs <=3 days / >24 h <=3 jours
Yes
Yes
1
Day(s) / Jour(s)
Died
Treatment / Traitement
(eg. description of the frequency and severity of the symptoms
On 15Dec2015, the dog exhibited lethargy. The dog was examined by a veterinarian, tested positive for lyme disease, was given a lyme vaccine and started on minocycline. The dog returned to the clinic approximately 2 hours later, foaming at the mouth and shaking, and was treated with dexamethasone and diphenhydramine injections. On 16Dec2015, the dog returned to the clinic seizuring, foaming mouth, and convulsing. The dog had additional bloodwork performed the results were unknown. The dog was started on zonisamide. On 17Dec2015 the dog died at home. No necropsy was performed. No further information is expected; this case is closed. Follow up received on 14 Jan 2016: On 15-Sep-2015, a 15 month old, 23 pound, neutered, male, Pug canine, in good condition, with no known concomitant medical conditions, had 1 Seresto Dog (unspecified) (Flumethrin-Imidacloprid) collar placed around the neck by the owner. On 15 Dec 2015, the dog exhibited lethargy. The dog was examined by a veterinarian, tested positive for Lyme disease, was given a Lyme vaccine and started on minocycline. Approximately 1 hour later, the dog had an episode of foaming at the mouth and shaking. He was returned to the clinic, where he was examined and found to be normal. He was treated with dexamethasone and diphenhydramine injections. On 16 Dec 2015, the dog had another similar episode during the day. That evening, the dog had a third episode. He was returned to the hospital. While at the hospital, the dog had a fourth episode where the dog initially was shaking, then had facial twitching, foaming at the mouth, and a seizure. Blood work was performed and the only abnormalities were decreased phosphorus, slight leukocytosis, neutrophilia and monocytosis. Toxic exposure to something in the household could not be ruled out. The dog was started on zonisamide. On 17 Dec 2015 the dog died at home. No necropsy was performed. No further information is expected; this case is closed.
Death
Lethargy is an unspecific sign and may have multiple possible causes in an animal. Lyme disease is a tick borne bacterial disease. In this case, no ticks seen on dog. Even as per the labelled claim of efficacy of the product, attachment of single ticks and even sucking of blood and thus transfer of tick borne diseases cannot be excluded while the collar is worn, especially when infestation pressure is high. Foaming at the mouth and shaking are not anticipated with appropriate topical product administration. Multiple episodes of these signs along with facial twitching were likely introducing the subsequent seizure. The product is not anticipated to cause serious neurological disorders such as seizures after appropriate topical product administration. Even with oral product exposure, which was anyway not reported in this case, only transient gastrointestinal signs would be expected. The abnormal blood parameters are unexpected may be associated with other reported signs. Death is not expected following appropriate topical product application as inconsistent with products pharmacological profile. In this case, Lyme disease, other medications administered (including a vaccine) and the suspected toxic exposure are more likely to have contributed to the signs. Finally time to onset was exceptionally long (3 months). Considering all these aspects, although no necropsy was performed, product relation was deemed to be unlikely.