December 1, 2006
FDA Warns Horse Owners and Veterinarians About Deaths Due To Unapproved Clenbuterol - Supplemental Information
FDA has become aware of the deaths of several horses in the State of Louisiana associated with the use of an unapproved product labeled as “Clenbuterol HCL.” The following is supplemental information to the CVM Update that was posted November 24, 2006 (http://www.fda.gov/cvm/CVM_Updates/horsedeath.htm) to help consumers identify the approved product.
Boehringer Ingelheim Vetmedica, Inc. is the only manufacturer of approved clenbuterol products. However, the approved products are available under two different trade names. The trade names for the approved products are:
Ventipulmin ® Syrup (under the Boehringer name),
Aeropulmin ® Syrup (under several different distributor names)
In addition, note that the Aeropulmin ® Syrup product is available under several different distributor names. Regardless of the trade name or distributor name all approved products should have the following statement on the label:
NADA 140-973 Approved by FDA
These products are available only by prescription from your veterinarian. If you have any doubt as to the safety of the product in your possession, please consult your veterinarian.
Animal Drugs @ FDA database and to the information about NADA 140-973
Horse owners and veterinarians who are aware of horse injuries or deaths that may have been caused by “Clenbuterol HCL” are urged to report this to the FDA office in their area. This is a link to a listing of FDA Consumer Complaint Coordinators -- http://www.fda.gov/opacom/backgrounders/complain.html.
Issued by:
FDA, Center for Veterinary Medicine,
Communications Staff, HFV-12
7519 Standish Place, Rockville, MD 20855
Telephone: (240) 276-9300 FAX: (240) 276-9115
Internet Web Site: http://www.fda.gov/cvm
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