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  1. CVM Updates

FDA Warns Six Sellers of Unapproved Seizure Drugs for Animals

January 7, 2025

Today, the U.S. Food and Drug Administration posted warning letters sent to six firms selling unapproved drugs that claim to treat and control seizures in dogs and cats. 

The following companies received warning letters:

The products named in the warning letters are not FDA-approved or conditionally approved – the legal pathways for drugs for dogs and cats to reach the marketplace. Therefore, the FDA has not verified their safety, effectiveness, or manufacturing methods as part of the animal drug review process.  All FDA-approved animal drugs carry a statement on their labeling stating they are approved by FDA and include their New Animal Drug Application; Abbreviated New Animal Drug Application (for generic animal drugs) or Conditional Approval number. 

The unapproved products were sold on the firm’s websites, social media pages and Amazon shops without a prescription or other veterinary oversight. Animal drugs used to treat and control seizures are not safe for animal use except under the professional supervision of a licensed veterinarian because a veterinarian’s specialized training and experience is needed to properly diagnose the condition and manage the health of animals with seizure disorders. Many health problems can cause seizures in animals, including genetic disorders, anemia, head trauma, liver disease, diabetes, cancer and exposure to toxins.

Idiopathic epilepsy is one of the most common seizure disorders in dogs and is a serious or life-threatening condition that is estimated to affect approximately 1% to 5% of all dogs. “Idiopathic” means the root cause for the seizures is unknown. The FDA has conditionally approved two animal drugs, KBroVet-CA1 and Fidoquel-CA1, to treat idiopathic epilepsy in dogs under an expanded conditional approval pathway for drugs intended to treat a serious or life-threatening disease or address an unmet health need. Veterinarians also have treatment options in the form of extralabel use, such as prescribing human drugs for use in animals or prescribing an animal drug for use in a different species of animal. 

Anyone currently administering the unapproved animal drugs included in these warning letters should consult a licensed veterinarian to obtain an accurate diagnosis and appropriate treatment. If you have been giving these products to your pets, safely dispose of them. Pet owners and veterinarians are encouraged to report animal adverse events to the FDA’s Center for Veterinary Medicine: How to Report Animal Drug and Device Side Effects and Product Problems. 

The FDA has asked the companies to respond to the warning letters within 15 days of receipt to state how they will address the violations cited in the warning letters. Failure to address the violations promptly may result in the FDA’s legal action, including product seizure and/or a court order requiring a company to stop manufacturing and distributing unapproved products.

The FDA will continue to monitor the marketplace and take necessary steps to protect human and animal health from unapproved animal drugs that can put people and animals at risk.

Related Information

Issued by FDA Center for Veterinary Medicine. 
For questions, Contact CVM.

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