FDA Warns About Noise Aversion Drug That May Cause Overdose in Dogs

Dog owners and lovers should be warned: a noise aversion drug is causing canines to accidentally overdose.

The Food and Drug Administration has issued the warning on its website on Friday about Sileo, the noise aversion drug for dogs, that could be potentially dangerous to beloved pets.

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Sileo is usually given to dogs to treat noise aversion or signs related to anxiety.

Zoetis started marketing the said drug in May 2016. Zoetis happens to be the world’s largest producer of medicine and vaccinations for animals. The FDA first became aware of the issues with the said drug last year. However, the problems persisted.

The FDA warns that Sileo is packaged in an oral dosing syringe with a ring-stop mechanism on the plunger that should 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. It is crucial that the person administering the product understands how to operate the syringe correctly before giving the product to the dog.

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Some dogs have experienced clinical signs of overdose, including lethargy, sedation, sleepiness, slow heart rate, loss of consciousness, shallow or slow breathing, trouble breathing, impaired balance or incoordination, low blood pressure, and muscle tremors.

No deaths have been reported. The FDA has not fully established if these overdoses were due to improper use of the ring-stop.

The FDA received 26 additional reports of overdoes after contacting the American Drug Safety Commission

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In response, the FDA asked Zoetis to revise its labeling to better emphasize the need to secure ring-stop mechanism to prevent overdose.

The revised labeling is now in place. Zoetis also adjusted by providing enhanced training videos on its websites to assist veterinarians when teaching owners and handlers how to properly handle and administer Sileo.

Source:

https://www.fda.gov/AnimalVeterinary/NewsEvents/CVMUpdates/ucm559954.htm