(WPRI) — To those with dogs who are scared of loud noises, the Food and Drug Administration (FDA) is warning that a drug used to treat noise aversion could lead to an accidental overdose.
According to the FDA, Sileo is a prescription gel commonly prescribed by veterinarians for dogs who suffer from anxiety or fear due to noise.
The FDA-approved gel is administered through an oral dosing syringe with a ring-stop mechanism on the plunger that must be dialed and locked into place to set the correct dose.
The doses are determined by the weight of the dog, and are labeled on the side of the plunger with “dots.” A dosing chart inside the packaging matches the amount of dots to the weight of the dog.
- MORE: Sileo dosing chart »
The FDA said an overdose can result if the ring-stop mechanism isn’t fully locked. Officials said it is very important dog owners understand how to operate the syringe correctly before administering the product.
According to the FDA, some dogs who have been given Sileo have experienced 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.
The FDA said no deaths have been reported, and the FDA is still trying to determine if the reported overdoses were due to improper use of the ring-stop. The FDA is encouraging veterinarians to teach dog owners how to properly administer the drug before prescribing it, and for dog owners to be aware of the potential signs of an overdose.
The manufacturer, Zoetic, began marketing the drug back in 2016. But the FDA was first alerted to potential overdoses back in 2017. The FDA reissued the warning Friday, as problems with the drug persisted.