US FDA Grants Emergency Use Authorization for Simparica TRIO Against New World Screwworm

• The FDA has issued an Emergency Use Authorization (EUA) for Simparica TRIO to treat New World screwworm infestations in dogs and puppies.
• Simparica TRIO is only authorized for treatment of NWS, not prevention, and must be prescribed by a licensed veterinarian due to potential neurologic adverse reactions.
• The EUA will be effective until it is revoked or the HHS Secretary terminates the declaration that justifies the emergency use of animal drugs for NWS.
• Dog owners should consult with their veterinarian to determine if Simparica TRIO is appropriate for their dog and monitor for signs of infestation, such as visible maggots or foul odors in wounds or body openings.

The FDA continues to authorize products to give veterinarians and pet owners multiple treatment options, in the unlikely event animals under their care become infested with New World screwworm.

While most dogs in the US are at low risk of New World screwworm (NWS) exposure due to their geographic location, some areas have reported infestations. Texas and New Mexico are currently the only states where NWS has been detected. In these regions, dog owners should be aware of the signs of infestation, including visible maggots or foul odors in wounds or body openings. If a dog is suspected to be infested, immediate veterinary care is necessary.

The FDA's Emergency Use Authorization (EUA) for Simparica TRIO provides veterinarians and pet owners with an additional treatment option in the unlikely event of NWS infestation.

The FDA has issued an EUA for Simparica TRIO, a product that contains sarolaner, moxidectin, and pyrantel. This authorization is effective until it is revoked or the HHS Secretary terminates the declaration that justifies the emergency use of animal drugs for NWS. The EUA allows veterinarians to prescribe Simparica TRIO for the treatment of NWS myiasis in dogs and puppies.

Lawyers advising pet owners or veterinarians on compliance with the FDA's EUA for Simparica TRIO should be aware that this product can only be prescribed by a licensed veterinarian due to potential neurologic adverse reactions. Dog owners should consult with their veterinarian to determine if Simparica TRIO is appropriate for their dog.

The FDA emphasizes that professional expertise is required to monitor for and respond to the potential side effects of Simparica TRIO, including muscle tremors, loss of coordination, and seizures.

Lawyers advising pet owners or veterinarians on compliance with the FDA's emergency use authorization for Simparica TRIO should note that this product is only authorized for treatment of New World screwworm infestations, not prevention, and must be prescribed by a licensed veterinarian due to potential neurologic adverse reactions.

Source: Original reporting via FDA press release