The FDA has issued an alert for pet owners and veterinarians about the risk of possible accidental overdose of noise aversion drug Sileo.
According to the statement, accidental overdose can occur if the drug, which uses a dial-controlled dosing mechanism, is administered without locking the dosing ring stop.
To date, the FDA 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. At this time, the FDA has not determined if these overdoses were due to improper use of the ring-stop.
— Statement from the Federal Food and Drug Administration
Sileo’s administration package features a dosage control ring stop mechanism. Accidental overdose can occur if the drug is administered while the ring stop is unlocked. (Photo courtesy Zoetis)
Sileo was initially released by Zoetis in 2016 as a treatment for noise aversion in dogs. Noise aversion, or noise phobia, is a form of anxiety that accompanies a fear response to certain sounds. With over one third of dogs reported to be affected, it is a common, widespread problem for both dogs and their owners. Left untreated, noise aversion can result in stress, increased frequency and severity of episodes, and the development of undesirable behaviors, including escape.
Treatment for noise aversion has historically involved forms of behavior modification therapy, including counter-conditioning and desensitization therapy. The development of Sileo by Zoetis represents a major breakthrough in the treatment for noise aversion in dogs. To date, Sileo remains the only drug approved by the FDA for the treatment of canine noise aversion.
Both the FDA and Zoetis encourage pet owners and veterinarians to be aware of the possibility of accidental overdose and to review administration instructions thoroughly before use.