FDA continues to warn about risk of accidental overdosing of dogs with the noise aversion drug Sileo

UPDATE: FDA Animal Drug Safety Communication: FDA continues to warn about risk of accidental overdosing of dogs with the noise aversion drug Sileo From May 2016, when Zoetis began marketing Sileo, to May 16, 2018, the FDA has received a total of 54 adverse event reports involving Sileo overdoses in dogs due to the ring-stop mechanism not properly locking at the intended dose. In the year since the FDA published its original Animal Drug Safety Communication on this issue, the agency has received 26 additional reports of accidental Sileo overdoses in dogs. The FDA is reissuing this advisory because adverse events are continuing to occur. The agency continues to advise veterinarians to carefully educate owners and handlers how to properly use the syringe to avoid accidental overdosing. In 2017, after becoming aware of the adverse events related to ring-stop locking issues, the FDA asked Zoetis to revise its labeling to better emphasize the need to secure the ring-stop mechanism to prevent overdose. This revised labeling is now in use. Zoetis has also provided enhanced training videos on its website to help veterinarians teach owners and handlers how to properly handle and administer Sileo.