FDA Reissues Warning About Noise Aversion Drug Sileo

The U.S. Food and Drug Administration is warning veterinarians and pet owners about Sileo, a popular drug prescribed for noise aversion in dogs, as there is potential for accidental overdose.


Sileo has been marketed for the last two years as a prescription gel that is given to dogs to help alleviate anxiety and suffering from loud noises like thunderstorms or fireworks. Since released in May 2016, the U.S. Food and Drug Administration has documented 54 adverse event reports related to overdoses of Sileo in dogs, and the FDA has reissued a warning advisory to veterinarians and pet owners.


Related: Keeping Your Dog Safe During A Thunderstorm


The original warning advisory came out in May of 2017, but since the initial advisory, the FDA warns there is still great concern about overdosing the medicine as the product’s ring-stop mechanism does not always properly lock at the intended dose. This has resulted in an additional 26 accidental overdoses in dogs since that advisory in 2017, and the FDA wants all prescribing veterinarians and users of the drug to be more aware of the potential overdose.


When using the drug, it’s imperative that the syringe is properly locked before dosing and administering to pets. To date, no dog deaths have been reported


Signs of overdose include lethargy, sleepiness, slow heart rates, loss of consciousness, shallow breathing or difficulty breathing and impaired balance and coordination. Sileo is a popular drug given during this time of year as many communities hold fireworks displays to celebrate, and dog owners want to keep their dogs calm and anxiety-free.


Zoetis, the makers of Sileo, have online resources available for veterinarians and pet owners to show the proper operation of the syringe in detail. If pet owners feel there is a possible overdose of the medicine, they should consult their veterinarians immediately.


Related: Your Dog’s Noise Anxieties Are Silenced With The ThunderShirt


It is very important for pet owners and veterinarians to understand how to operate the syringe properly before administering the medication. Veterinarians should be aware of the possibility of an accidental overdose and provide proper education to dog owners before prescribing the medication.


Zoetis has provided online resources to demonstrate the proper operation of the Sileo syringe in detail for both veterinarians and dog owners.

Lori Ennis
Lori Ennis

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