July 3, 2023
In response to adverse event reports that the FDA has received involving Sileo overdoses in dogs due to the ring-stop mechanism not properly locking at the intended dose, Zoetis has developed a new dosing syringe that is expected to become available in 2024. The new dosing syringe will require the user to twist the dosing ring along a threaded plunger. It will no longer move freely along the plunger and will not require a separate locking step once the dose has been selected, in an attempt to prevent unintentional overdose.
The new dosing syringe will be packaged in an updated carton to distinguish it from the previous version when it becomes available. The Client Information Sheet will also be updated to provide instructions for operating the new dosing syringe, and the sponsor will update the training materials, including a video on how to administer the product with the new syringe.
Issued by FDA Center for Veterinary Medicine.
For questions, Contact CVM.