FDA issues warning to multiple firms selling unapproved seizure medication

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The FDA posted warning letters to firms selling unapproved drugs, claiming that the drugs control and treat seizures in dogs and cats. Each of the products named in the warning letters are not FDA-approved or conditionally approved, therefore the safety of the products have not been verified by the FDA for safety, effectiveness, or manufacturing methods.

The warning letters went to the following companies¹:

• Doc Ackerman’s Pet Products: Doc Ackerman’s– Epilepsy and Seizure Formula
• Energetic Essences: LLC dba Pet Essences: Seizure formula
• Evolution Pets: SeizureGuard Plus and Life Span Arthritis & Mobility Advanced Enzyme Therapy
• HD Frenchies, LLC/Bully Baum: Bully Baum No Seize, Can-B-Gone - Cancer Oil Extract, and Brain & Neurological
• Nutrition Strength Ltd EOOD: Dog Seizure and Epilepsy Supplement and Blood Support for Dogs
• Vet Select Formula, Inc: Vet Select Nuroplex Capsules and Vet Select Nuroplex - 2oz homeopathic Spray

According to the FDA,¹ each of the unapproved products were sold on the firm’s websites, Amazon shops, and social media pages without prescriptions or other veterinary oversight.¹ Drugs used to treat and control seizures are not safe for use except under supervision of a licensed veterinarian due to their specialized training and experience.

Currently, the FDA has conditionally approved 2 animal drugs to treat idiopathic epilepsy in dogs under expanded conditional pathway, KBroVet-CA1 and Fidoquel-CA1. The pathway is used for drugs that are intended to treat serious and life-threatening diseases or address an unmet health need. The FDA also stated that veterinarians have the option for treatment in the form of extralabel use, such as prescribing drugs intended for human use in animals or prescribing an animal drug for use in a different species of animal.¹ Veterinary professionals or clients are encouraged by the FDA to report any animal adverse events to the FDA’s Center for Veterinary Medicine.

All products approved by the FDA carry a statement on the label stating their approval and include the products' new animal drug application, abbreviated new animal drug application (for generic animal drugs), or Conditional Approval number.

Any veterinary clients that have been administering any of the unapproved drugs included in the warning letters should consult a licensed veterinarian to gain an accurate diagnosis and receive appropriate treatment. Clients can safely dispose of the medications if they are on the FDA flush list, and if not, follow FDA instructions to discard the medication in the trash.²

The FDA asked the firms to respond to the sent warning letters within 15 days of receipt to explain how they will address the violations listed in the warning letters. If the companies fail to do so, it may result in legal action taken by the FDA, including seizing the products and/or a court order requiring the company to stop the distribution and manufacturing of the unapproved numbers.

Suspected unapproved drugs or devices can be reported to the FDA through FORM FDA 1932a “Veterinary Adverse Experience, Lack of Effectiveness or Product Defect Report" as well as to report adverse events for any approved or unapproved drug or animal device.³

References

1. FDA Warns Six Sellers of Unapproved Seizure Drugs for Animals. News release. U.S. Food and Drug Administration. January 7, 2025. Accessed January 7, 2025. https://www.fda.gov/animal-veterinary/cvm-updates/fda-warns-six-sellers-unapproved-seizure-drugs-animals?utm_medium=email&utm_source=govdelivery
2. FDA. Disposal of Unused Medicines: What You Should Know. US Food and Drug Administration. Updated September 3, 2024. Accessed January 7, 2025. https://www.fda.gov/drugs/safe-disposal-medicines/disposal-unused-medicines-what-you-should-know
3. FDA. How to Report Animal Drug and Device Side Effects and Product Problems. US Food and Drug Administration. Updated September 3, 2024. Accessed January 7, 2025. https://www.fda.gov/animal-veterinary/report-problem/how-report-animal-drug-and-device-side-effects-and-product-problems