FDA warns companies illegally selling seizure medications

The Food and Drug Administration (FDA) has issued warning letters to six companies selling unapproved drugs claiming to treat and control seizures in dogs and cats.

Idiopathic epilepsy is the major cause of recurrent seizures in dogs between 1 and 5 years of age. Two conditionally approved animal drugs are available to treat idiopathic epilepsy in dogs. Veterinarians also have treatment options in the form of extralabel use.

The products were being marketed without the necessary FDA approval or oversight, meaning their safety, effectiveness, and manufacturing standards have not been verified, the agency said in a January 7 announcement. The warnings were conveyed to these companies on November 12, 2024:

• Nutrition Strength Ltd. of Bulgaria with its Dog Seizure and Epilepsy Supplement and Blood Support for Dogs
• Evolution Pets for offering SeizureGuard Plus and Life Span Arthritis & Mobility Advanced Enzyme Therapy
• Doc Ackerman's Pet Products, which sells Doc Ackerman's-Epilepsy & Seizure Formula
• Energetic Essences LLC, doing business as Pet Essences, with its Seizures formula
• HD Frenchies LLC, doing business as Bully Baum, for selling Bully Baum No Seize, Can-B-Gone-Cancer Oil Extract, and Brain & Neurological products
• Vet Select Formula Inc. offering Vet Select Nuroplex Capsules and Vet Select Nuroplex-2oz Homeopathic Spray

These products were being sold on the companies' websites, social media platforms, and through Amazon, without a prescription requirement or 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," according to the announcement.

Idiopathic epilepsy, a common seizure disorder in dogs where the cause is unknown, affects an estimated 1% to 5% of the canine population and is considered serious or life-threatening. The FDA has conditionally approved two drugs, KBroVet-CA1 and Fidoquel-CA1, specifically for this condition under a special pathway for drugs treating serious or unmet health needs.

Pet owners currently using these unapproved drugs are asked to consult with a veterinarian for proper diagnosis and treatment, and to dispose of these products safely. The FDA encourages reporting any adverse effects observed in animals after their administration to its Center for Veterinary Medicine.

The agency has requested responses from the companies stating how the companies will correct the violations. Failure to correct the violations promptly may result in legal action, including product seizure or injunction, according to the FDA.

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