UKVDL Bulletin Alert: Unapproved Compounded Drugs

The recent cases of adverse events highlight issues that veterinarians should consider when using or prescribing compounded products.

Photo: Anne M. Eberhardt/The Horse

A bulletin was released May 16 by the U.S. Food and Drug Administration Center for Veterinary Medicine (FDA-CVM) regarding adverse effects associated with a compounded drug containing pyrimethamine and toltrazuril product used to treat the neurologic disease equine protozoal myeloencephalitis (EPM).

The release is available at www.fda.gov/AnimalVeterinary/NewsEvents/CVMUpdates/ucm397345.htm.

These cases highlight issues that veterinarians should consider when using or prescribing compounded products. In addition to the issues described in the release, veterinarians should also ensure the following:

  • Clients should be made aware that compounded drugs may be formulated in varying concentrations, based on the prescription provided for each individual case, and a label clearly stating dosing instructions should be attached to the product to avoid incorrect dosing by clients.
  • Veterinarians should double-check prescriptions for accuracy before submitting to the pharmacy; compounding pharmacists should confirm that the product is suitably formulated to provide appropriate doses of the drug(s).
  • If an adverse drug event is suspected, the FDA-CVM should be contacted. The link above provides contact information for reporting.
  • Veterinarians can receive updates and bulletins from the FDA-CVM by email; see the link above to find out how to receive these updates.

For more information, contact Cynthia Gaskill, DVM, PhD, veterinary toxicologist at the UKVDL, at 859/257-7912 or cynthia.gaskill@uky.edu.


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