Regulatory Brief

 FDA Advisory Committee: Public Health Consideration of Hydrocodone


Formal Title: [FDA–2012–N–0548] Drug Safety and Risk Management Advisory Committee; Notice of meeting

Brief Description:

The Food and Drug Administration (FDA) announced its notice of a meeting of a public advisory committee of the FDA, which was made open to the public.

AVMA Response:

As the Drug Safety and Risk Management Advisory Committee contemplates possible means to protect the public from misuse and abuse of hydrocodone, the AVMA took the opportunity to underscore the importance of hydrocodone used in veterinary medicine to relieve animal pain and suffering and to protect animal health. Human-labeled drugs, including some forms of hydrocodone, are utilized by some veterinary DEA registrants because there are relatively few animal-labeled drugs for the large variety of animal species and medical conditions veterinarians are expected to treat. It was for this reason the extralabel use of human-labeled drugs in veterinary medicine became a legal, FDA-regulated activity that was codified by the Animal Medicinal Drug Use Clarification Act of 1994.
 
Similar to human medicine, hydrocodone is used as an antitussive agent, specifically in canine medicine. Unfortunately, other antitussives that are available seem to be less effective than hydrocodone in some clinical scenarios. Hydrocodone used in combination with other analgesics is also used, and veterinarians have found some success with their use in dogs for the relief of pain.
 
The AVMA appreciates the FDA’s outreach to the public and stakeholders as the FDA considers the DEA’s request for consideration of the potential public health benefits and risks of hydrocodone and hydrocodone combination products.

Background Documents: