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The U.S. Food and Drug Administration on Thursday issued an advisory about compounded veterinary medications after four horses being treated for equine protozoal myeloencephalitis (EPM) died.
Adverse events such as seizures, fever and death were reported in two Kentucky horses and eight Florida horses that received a pyrimethamine-toltrazuril combination. Four of the horses died or were euthanized and six horses are recovering, FDA reported.
Wickliffe Veterinary Pharmacy of Lexington, Ky., compounded two lots—one paste and one oral suspension—containing pyrimethamine and toltrazuril.
"At this time, FDA testing indicates that one lot of product contained higher levels of pyrimethamine than the labeling indicates," the agency stated.
"All of the products in these lots are accounted for and are no longer in distribution," FDA added.
The usual dose of pyrimethamine in horses is 1 mg/kg when combined with sulfadiazine as an FDA-approved treatment for EPM.
Toltrazuril is not approved for use in horses, the agency noted. Bayer Animal Health offers toltrazuril as the active ingredient in Baycox, an approved anticoccidial parasiticide used with poultry, piglets and cattle.
"In general, FDA has serious concerns about unapproved animal drugs, including certain compounded animal drugs," the agency reported. "These drugs are not evaluated by FDA and may not meet FDA's strict standards for safety and effectiveness."
Drugs approved for the treatment of EPM, a neurological disease caused by a protozoal infection, include ponazuril, diclazuril and the pyrimethamine-sulfadiazine combination.
Wickliffe Veterinary Pharmacy, a high-quality provider of customized medicinal solutions for veterinarians, is working cooperatively with federal health officials to learn more about the cause of the adverse events involving horses that received a compounded product from the pharmacy. We wish to extend our deepest sympathies to the owners of, and equine professionals associated with, the horses that have died or been euthanized.
The medication prepared by Wickliffe was specifically made for and dispensed to the horses for which the medication was prescribed. No other animal patients received the prescribed medication in question. The FDA has confirmed that all of the preparations are accounted for and secured. Accordingly, any risk of further adverse effects has been eliminated. There is no indication that any other products prepared by the pharmacy are unsafe in any way.
Wickliffe adheres to the highest safety and quality standards of the compounding pharmacy profession and follows all applicable state and federal guidelines. The pharmacy has a strong reputation and extensive history of providing excellent preparations to the equine industry. Wickliffe pledges its full dedication to ensuring the quality of its procedures.