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Counterfeit Clenbuterol Killing Horses
by: Kimberly S. Brown, Editor
November 21 2006 Article # 7557
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Two sources have verified that there have been an undetermined number of deaths in Louisiana since last week from an illegal clenbuterol product. One report was that six horses are known dead, and approximately 10 more have been severely affected by the illegal product. Reportedly deaths have occurred with only one dose.
There have been unsubstantiated reports that the product might have been smuggled in from Belize.
Bob Stenbom, DVM, a field technical veterinarian with Boehringer-Ingelheim, makers of the legal clenbuterol product called Ventipulmin Syrup, stated: Boehringer-Ingelheims Ventipulmin is the only licensed clenbuterol product in the United States and world-wide. Anything else is counterfeit. Boehringer-Ingelheim also producesa private label clenbuterol sold to distributor customers under the name Aeropulmin. This is also a legal product.
The deaths reportedly were caused from the illegal product being many times more potent than the licensed, legal product.
One Louisiana veterinarian said he is not sure if the illegal product will make its way into other parts of the United States, but horse owners should beware.
If you have a clenbuterol product that is not manufactured by Boehringer-Ingelheim, report it to your veterinarian, your state veterinarian, or your local law enforcement officials.
In 1998 the FDA approved a new animal drug application (NADA) for Boehringer-Ingelheim Vetmedica's Ventipulmin Syrup, which contains a small amount of clenbuterol, as a restricted use, prescription-only drug for treating horses affected with airway obstruction (allergies, chronic obstructive pulmonary disease, etc.). When FDA approved the NADA for Ventipulmin, several controls were put in place to ensure that this drug would not be misused in food-producing animals.
The FDA has stated previously that: In recent years, availability of illegal clenbuterol formulations, produced as compounded drug product, has increased steadily. The Animal Medical Drug Use Clarification Act (AMDUCA) permits compounding under very limited circumstances. Compounding must be done only on the order of a licensed veterinarian, based upon a valid veterinarian/client/patient relationship from approved human or veterinary drugs. In addition, other criteria must be met including establishing the need for a compounded product, and prohibitions against use of some drug products in food-producing animals. AMDUCA does not permit compounding from bulk drugs. Bulk clenbuterol should only be available for use by Boehringer-Ingelheim Vetmedica, Inc., in the production of the approved clenbuterol product.
When an approved product is available, a compounded product is not permitted to be used unless it meets the criteria in AMDUCA. Since there is an approved clenbuterol product available, only limited compounding from approved Ventipulmin is permitted. Clenbuterol products that mimic the approved product are unapproved new animal drugs and are not legal for preparation, sale, and use.
Veterinarians and animal owners should be aware that these unapproved clenbuterol products have not been shown to be safe and effective and may not be prepared under conditions that are controlled to produce a consistent, quality product. Prescribing, purchasing, or distributing compounded clenbuterol is in violation of Federal law. Veterinarians ultimately assume responsibility for the efficacy, safety, and composition of drugs prescribed in this manner.
by: Kimberly S. Brown, Editor
November 21 2006 Article # 7557
Article Tools
Two sources have verified that there have been an undetermined number of deaths in Louisiana since last week from an illegal clenbuterol product. One report was that six horses are known dead, and approximately 10 more have been severely affected by the illegal product. Reportedly deaths have occurred with only one dose.
There have been unsubstantiated reports that the product might have been smuggled in from Belize.
Bob Stenbom, DVM, a field technical veterinarian with Boehringer-Ingelheim, makers of the legal clenbuterol product called Ventipulmin Syrup, stated: Boehringer-Ingelheims Ventipulmin is the only licensed clenbuterol product in the United States and world-wide. Anything else is counterfeit. Boehringer-Ingelheim also producesa private label clenbuterol sold to distributor customers under the name Aeropulmin. This is also a legal product.
The deaths reportedly were caused from the illegal product being many times more potent than the licensed, legal product.
One Louisiana veterinarian said he is not sure if the illegal product will make its way into other parts of the United States, but horse owners should beware.
If you have a clenbuterol product that is not manufactured by Boehringer-Ingelheim, report it to your veterinarian, your state veterinarian, or your local law enforcement officials.
In 1998 the FDA approved a new animal drug application (NADA) for Boehringer-Ingelheim Vetmedica's Ventipulmin Syrup, which contains a small amount of clenbuterol, as a restricted use, prescription-only drug for treating horses affected with airway obstruction (allergies, chronic obstructive pulmonary disease, etc.). When FDA approved the NADA for Ventipulmin, several controls were put in place to ensure that this drug would not be misused in food-producing animals.
The FDA has stated previously that: In recent years, availability of illegal clenbuterol formulations, produced as compounded drug product, has increased steadily. The Animal Medical Drug Use Clarification Act (AMDUCA) permits compounding under very limited circumstances. Compounding must be done only on the order of a licensed veterinarian, based upon a valid veterinarian/client/patient relationship from approved human or veterinary drugs. In addition, other criteria must be met including establishing the need for a compounded product, and prohibitions against use of some drug products in food-producing animals. AMDUCA does not permit compounding from bulk drugs. Bulk clenbuterol should only be available for use by Boehringer-Ingelheim Vetmedica, Inc., in the production of the approved clenbuterol product.
When an approved product is available, a compounded product is not permitted to be used unless it meets the criteria in AMDUCA. Since there is an approved clenbuterol product available, only limited compounding from approved Ventipulmin is permitted. Clenbuterol products that mimic the approved product are unapproved new animal drugs and are not legal for preparation, sale, and use.
Veterinarians and animal owners should be aware that these unapproved clenbuterol products have not been shown to be safe and effective and may not be prepared under conditions that are controlled to produce a consistent, quality product. Prescribing, purchasing, or distributing compounded clenbuterol is in violation of Federal law. Veterinarians ultimately assume responsibility for the efficacy, safety, and composition of drugs prescribed in this manner.
