IV AAEP News August 2019
ASSOCIATION
5 things to know about AAEP this month
1. Don’t miss the early-bird savings deadline for annual convention registration. Register by Sept. 15 at
convention.aaep.org and save $200.
2. Renowned equine surgeon Dr. Dean Richardson will deliver the Milne Lecture at the 2019 AAEP Annual Convention.
3. Download a free copy of the AAEP Foundation-supported e-book Ultrasonography of the Equine Pastern Region at
https://tinyurl.com/aaepfeb.
4. The AAEP Foundation in July brought together stakehold- ers for a planning session to develop strategies for improving the industry’s disaster preparedness and response.
5. Save time on client education events. Download custom- designed PowerPoint presentations on numerous topics at
aaep.org/
dashboard/clienteducation.
Why using compounded toltrazuril for the treatment of EPM is outside the standard of care By Jane G. Owens, DVM, DACVCP
Despite the availability of three FDA-approved products for treatment of Equine Protozoal Myelitis (EPM), a number of com- pounding pharmacies are selling oral preparations of toltrazuril as a treatment for this serious disease.
Dr. Jane G. Owens
Toltrazuril is not approved by the FDA for use in horses. Compounding pharmacies are offering this preparation at lower price points than the FDA-
approved products. Veterinarians should understand that “cheaper drug cost” is not a valid reason to use compounded products when FDA-approved products are available for their patients.
Use of compounded products when approved options are marketed puts both the patient and practitioner at risk. We’ve seen this in the press a number of times in recent years. In 2014, a compounded product containing a com- bination of toltrazuril and pyrimethamine resulted in the needless death of four horses and serious injuries to six others1 letter2
. This event prompted the FDA to issue a warning to the pharmacy involved.
Three products to treat EPM are currently approved by the FDA. These are prescription drugs and can be used only by or on the order of a licensed veterinarian.
Ponazuril is marketed as Marquis® Antiprotozoal Oral
Paste by Boehringer Ingelheim Animal Health and administered once daily for 28 days either with or without a loading dose. Ponazuril is the active
metabolite of toltrazuril and is often referred to as tol- trazuril sulfone. This chemical similarity does not make these drugs equivalent and they are in fact two different drugs with differing safety and efficacy profiles.
Sodium is marketed as ReBalance®
by Pegasus
Laboratories as an oral suspension administered once daily for 90 to 270 days.
Health as a pelleted, alfalfa-based top-dressing which is fed for 28 days.
The AAEP urges practitioners to use FDA-approved products, when available, to treat their patients with EPM. An excellent review of EPM diagnosis and treatment is available on the AAEP website3
. For further reading on the
ethical use of compounded products, please see Dr. Kenton Morgan’s ethics feature in the February 2019 issue of EVE4
.
Dr. Owens is director of companion animal research at Elanco Animal Health in Greenfield, Ind., and chair of the AAEP’s subcommittee on compounding. She is past president of the American Academy of Veterinary Pharmacology and Therapeutics and serves as president and founding member of the Veterinary Pharmacology Research Foundation.
References 1
Pyrimethamine deaths:
http://veterinarynews.dvm360.com/compounded-drug-may-have- killed-four-horses-fda-reports 2
FDA warning letter:
https://www.fda.gov/inspections-compliance-enforcement-and-crimi- nal-investigations/warning-letters/wickliffe-pharmaceutical-inc-08142014 3
AAEP EPM Ref:
https://aaep.org/horsehealth/equine-protozoal-myeloencephalitis 4
“Using compounded products within the standard of care,” Equine Veterinary Education, February 2019: Kenton Morgan EVE article.
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