FDA Approves Restricted Use Of Clenbuterol For Horses

On May 11, 1998, the Food and Drug Administration (FDA) approved Ventipulmin (clenbuterol hydrochloride) Syrup for use in horses affected with airway obstruction, such as occurs with Chronic Obstructive Pulmonary Disease (COPD), also known as  heaves. There are a large number of horses afflicted with this condition, and many veterinarians, horse owners, and members of horse-related veterinary and owner associations have been eager to see the drug available in the United States for reducing pain and suffering in affected horses.

Ventipulmin Syrup is an orally administered product used to decrease the labor of breathing in horses with obstructive airway disease. The product is available only by prescription. The recommended duration of treatment is 30 days. The most notable side effects are sweating, muscle tremors, hives, restlessness, and increased heart rates. These subside within a few days after the initiation of treatment.

Ventipulmin Syrup contains a small amount of clenbuterol, which belongs to the family of compounds called Beta-agonists. It is well known that clenbuterol affects lung and heart functions. In Europe, human illness was associated with consumption of meat containing clenbuterol residue. The most notable incident occurred in Spain in 1990 and was associated with consumption of liver from animals that had been illegally administered clenbuterol. Symptoms from clenbuterol can include increased heart rate, muscular tremors, headache, dizziness, nausea, fever, and chills. Concerns over the abuse of clenbuterol in food animals in the United States have led to strict enforcement against illegal sales and use. FDA has added clenbuterol to the list of drugs that are prohibited from extra-label use in animals (Code of Federal Regulations, Title 21, Part 530.41), and FDA and USDA both use tests that can monitor for residues at slaughter.

The sponsor of Ventipulmin, Boehringer Ingleheim Animal Health, Inc. (BIAH), of St. Joseph, Mo., is taking several steps to ensure that the approved drug is not misused.

These include:

  • Instructing salespersons to notify practicing veterinarians that the use of this product in food animals is prohibited, and that veterinarians involved in such illegal activities will be held accountable.
  • Notifying salespersons and veterinarians that law enforcement agencies can test food animals for signs of exposure to clenbuterol.
  • Providing sales information on Ventipulmin to FDA, including names and addresses of purchasers, to enable FDA to track suspicious distribution patterns.

FDA believes that the controls BIAH has instituted will substantially assist the Agency prevent the illegal use of clenbuterol in food-producing animals. FDA's approval of clenbuterol for use in horses is in concert with the conclusions of FDA's Veterinary Medicine Advisory Committee (VMAC). In a November 1993 meeting, the VMAC concluded that Ventipulmin offered no significant increased risk of diversion and misuse as compared to illicit sources of this drug, and that no extra restrictions (beyond the existing post-approval monitoring and enforcement activities by FDA and the actions to be taken by the sponsor) should be applied to the distribution and sale of this product. FDA believes that the drug can be used in compliance with its labeling to reduce pain and suffering in horses, and that adequate means are in use to safeguard the food supply from illegal residues.

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