Published May, 2014

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 acompounded drug containing pyrimethamine and toltrazuril product used to treat the neurologic disease equine protozoal myeloencephalitis (EPM).

The release is available atwww.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.