Counterfeit clenbuterol found in treated horses

BATON ROUGE, LA. –– The Louisiana Department of Agriculture and Forestry is investigating the cases of two horses administered counterfeit clenbuterol to determine if the unapproved drug is responsible for their deaths.

Veterinarians at the Louisiana State University (LSU) School of Veterinary Medicine large animal clinic treated three horses in November after they had been administered a counterfeit clenbuterol product, says Steven Barker, LSU professor of veterinary physiology, pharmacology and toxicology, PhD and state chemist for the Louisiana Racing Commission.

The horses were agitated and distressed with accelerated heart rates upon their arrival, suffering from "basically an induced overdose," says Jill Johnson, DVM and LSU professor of equine medicine. While Johnson did not directly treat the horses, she says, "from what I understand, some collapsed, some died and they had fairly severe heart rates and breathing."

After arriving at the hospital, two had to be euthanized and one was sent home, Barker says. "It was a massive overdose. It produced profuse sweating and stimulation of the horses' central nervous system."

The Louisiana Department of Agriculture has been investigating the cases for almost a month to determine if the counterfeit drug caused the deaths of the horses, says Ashley Rodrigue, the department's public information officer. The investigation awaits a necropsy report from LSU before any findings can be released. Once the investigation is complete, Rodrigue advises the department might be able to bring a solid case with charges.

Testing of the administered drug, purchased at a tack shop, revealed it was a generic clenbuterol product but 70 times stronger than approved by FDA. Ventipulmin Syrup, manufactured by Boehringer Ingelheim, is the only licensed clenbuterol product in the United States and worldwide; there is no legal generic version. As a bronchodilator, the drug is used on horses with respiratory problems to relax and soothe muscles.

"It was in a white bottle with a flip-top spout. It held about a quart of the material. There was no labeling, as to precautions or anything else," Barker says of the drug container brought in with the horses by the trainer. The bottle only contained labeling that said "clenbuterol hydrochloride," but the dosage matched that of Ventipulmin.

"Veterinarians and horse owners should pay attention to the packaging to make sure that the product is in the original packaging from Boehringer Ingelheim," says John Cary, DVM and Boehringer's manager of companion animal technical services.

Use of these counterfeit products can be curbed, Cary says, through "education of the horse owners and veterinarians on the value of using FDA-approved products to ensure consistency, safety and efficacy.

Although little can be done to help an animal suffering adverse affects from a counterfeit clenbuterol drug, Johnson says "this is a fairly unusual situation" that is not seen often in the veterinary profession.

Cracking down on counterfeits

While the presence of counterfeit drugs in the United States is uncommon, according to FDA, the agency created a Counterfeit Drug Task Force in 2004 to address growing concern regarding these drug types. "We believe that counterfeiting is quite rare within the U.S. drug distribution system because of the extensive scheme of federal and state regulatory oversight and the steps taken by drug manufacturers, distributors and pharmacies to prevent counterfeit drugs from entering the system," the task force says in its 2006 yearly report released in June.

Counterfeit products can be dangerous to animals or humans that come in contact with them because they can be contaminated, contain the wrong active ingredients, be made with the wrong amount of ingredients, contain no active ingredients at all or be distributed in phony packaging.

The task force offered multiple recommendations to further monitor and regulate drug authenticity through additional regulation and electronic methods, including improved distribution, trace and tag requirements.

"I strongly concur that increasing the safety and security of the nation's drug supply and protecting it from the increasing sophisticated threat of counterfeit drugs is critically important," says FDA Commissioner Andrew von Eschenbach, in a statement regarding the task force report. Supporting the task force's recommendations, he advised they be implemented to further improve drug security.

In addition to new measures, FDA advises working with licensed pharmacies and qualified veterinarians when seeking prescription drugs.