HEALTH - FDA Warns of Accidental Overdose in Dogs from Sileo

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The US Food and Drug Administration (FDA) is alerting dog owners and veterinarians about the risk of accidental overdose to dogs treated with the drug Sileo.

Sileo was put on the market May 2016 and is the first drug the FDA has approved for treating noise anxiety in dogs.

Noise anxiety has been challenging to manage with past options for treatment including behaviour modification, anti-anxiety medicine, tranquilizers and gadgets like the ThunderShirt.

Sileo is packaged in an oral dosing syringe with a ring-stop mechanism on the plunger that must be “dialed” and locked into place in order to set the correct dose for the dog.

Overdose can result if the ring-stop is not fully locked, therefore it is very important that the person administering the product understands how to operate the syringe correctly before giving the product to the dog.

The FDA has received 28 reports involving Sileo overdoses in dogs due to the ring-stop mechanism not properly locking at the intended dose.

While no deaths have been reported, in 15 out of the 28 reports, dogs experienced clinical signs of overdose, including lethargy, sedation, sleepiness, slow heart rate, loss of consciousness, shallow or slow breathing, trouble breathing, impaired balance or lack of coordination, low blood pressure, and muscle tremors.

The FDA is warning that all veterinarians and users of the product should be aware of the possibility of accidental overdose and how to use the syringe applicator properly.

Zoetis, the manufacturer of the drug, has provided online resources which demonstrate the proper operation of the syringe and administration technique in detail for veterinarians at Sileodvmus.com, and for dog owners at Sileodogus.com.