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# FDA Alert on Zoetis’ Noise Aversion Drug for Dogs
- URL: https://www.fdaweb.com/fda-alert-on-zoetis-noise-aversion-drug-for-dogs/
- Published: 2017-05-23T12:00:00.000Z
- Updated: 2026-09-14T22:25:26.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5138753

FDA 5/23 alerted veterinarians and dog owners to a risk of accidental overdose in administering Sileo (dexmedetomidin), an oral prescription gel marketed by Parsippany, NJ-based Zoetis for canine noise aversion. According to an FDA [news release](https://www.fda.gov/AnimalVeterinary/NewsEvents/CVMUpdates/ucm559954.htm?source=govdelivery&utm%5Fmedium=email&utm%5Fsource=govdelivery), Sileo is packaged in a 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,” the agency says. “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.”

Zoetis began marketing Sileo year ago, and so far FDA says it has received 28 reports involving Sileo overdoses in dogs due to the ring-stop mechanism not properly locking at the intended dose. In some cases, the entire contents of the dosing syringe were administered to the dog. 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 incoordination, low blood pressure, and muscle tremors. No deaths have been reported, FDA says.