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U.S. Department of Health and Human Services

Animal & Veterinary

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NATIONWIDE RECALL OF MIRACLE LEG PAINT

FDA Veterinarian Newsletter 2002 Volume XVI, No IV

CVM received a telephone call from the Veterinary Diagnostic Laboratory, Auburn, Alabama, concerning the death of a horse following application of a mercuric chloride blistering agent to the legs. The use of mercury blistering agents to treat lameness in horses is outdated, unsafe for animals and humans, and outside the scope of modern veterinary medicine.

The Miracle Leg Paint was purchased from the Equine Miracle Corporation in Grapeland, Texas. Mercury compounds in human drug products were prohibited following a notice in the Federal Register, Vol. 63, No. 77, April 22, 1998. All mercury-containing products were subject to removal from the market place in order to reduce human exposure and safeguard the public health regardless of the source of mercury in pharmaceuticals or medical devices.

On May 30, 2002, Equine Miracle Corp, agreed to a nationwide voluntary Class I Recall of Miracle Leg Paint, and agreed to stop manufacturing the product.

On June 17, 2002, CVM received another Adverse Drug Event Report from Louisiana State University, Veterinary Teaching Hospital. A horse became frantic and maniacal and was euthanized shortly after admission to the Veterinary Teaching Hospital. Heavy metal poisoning was suspected and toxicology tests revealed 240 ppm of mercury in the kidney, confirming mercury poisoning. The owner admitted to using Miracle Leg Paint on the horse every two weeks since November 2001.

There are no approved veterinary drug products that contain mercury as an active ingredient, and the use of mercuric blistering agents is not generally recognized as safe and effective. There are safety concerns for humans handling products containing mercuric chloride blistering agents. Poisoning and death have occurred in humans after applying the mercuric chloride products to large areas of the skin.

The product, administered topically on horses for the treatment of lameness, shin bucks, bows, chips, splints, and other horse leg ailments, was distributed nationwide to veterinarians, dealers, and consumers. All Miracle Leg Paint remaining on the market is subject to this recall.

Consumers who have purchased this veterinary drug are urged not to use it but to instead destroy the product by contacting their local waste management services and determining appropriate methods of destruction for this toxic product. Consumers with questions may contact Equine Miracle Corp. at 1-936-687-2800.