Biodyl
Biodyl is a trademark of Merial for a dietary supplement used in animals. It is manufactured in two formulations: a powder for use in an individual animal's drinking water, and an injectable solution. The injectable solution is available by veterinary prescription in some countries and over the counter in others.
Physical and chemical properties
Biodyl is formulated as a powder to be given in water, and as an injectable solution. The injectable solution is given under the skin, in the muscle, or in a vein, depending on the species of animal.[1] Its intended uses include reducing physiological stress such as due to being transported, and preventing azoturia in performance animals. The manufacturer's own product information describes Biodyl as an "injection solution containing metabolic constituents (adenosine triphosphoric acid or ATP, magnesium and potassium aspartate, sodium selenite and vitamin B 12) for debility, convalescence and myopathies."[2]
- Selenium (as sodium selenite)
- Potassium aspartate hemihydrate
- Magnesium aspartate tetrahydrate
- Methyl parahydroxybenzoate
- Propyl parahydroxybenzoate
- Excipient
Legal status
In the United States, Biodyl is not FDA approved, "in that there is not in effect an approval of an application filed with respect to its intended use or uses".[4]
Adverse effects
The manufacturer however, states that "Biodyl is safe when used as directed. It has been around from the 1950s and adverse reactions have been exceedingly rare over many years of tracking. Less than one animal in over 2 million doses."[5]
Veterinary use
Implication in polo pony deaths
In April 2009, the sudden deaths of 21 polo ponies at Palm Beach International Polo Club in Florida were attributed by a polo team captain to error or tampering in the team's supply of Biodyl.[6][7] A newspaper in Argentina reported 3 similar deaths of horses at an international competition in Uruguay.[6]
In the United States, concerns about a possible manufacturing error or tampering were lost amid a media outcry about the "illegal" use of "illegal" drugs not approved by the FDA, even "banned" by the FDA.[8] In the US, Biodyl is neither an illegal drug nor a banned drug, but it is an unapproved drug. Although Biodyl is a dietary supplement, a type of product that normally is not subject to FDA approval, FDA approval is required to market injectable solutions (except animal vaccines, which are subject to USDA approval). An Associated Press story misreported an October 2008 FDA refusal to permit commercial importation of the solution as a refusal to approve the solution. In fact, Biodyl is not FDA-approved because the manufacturer has never submitted an application for FDA approval.[9] Also, the FDA may permit the importation of unapproved drugs for personal use for pets.[10]
However, on April 23 a new concern emerged when a reputable pharmacy in Ocala, Florida disclosed that in compounding a preparation for the polo ponies which may have been intended to substitute for Biodyl, the pharmacy accidentally used an incorrect quantity of one of the ingredients.[11] Compounding of drugs for use in animals is a subject of concern for the FDA.[12]
See also
References
- ^ a b "BIODYL" (PDF). M.C.I. Santé Animale. Archived from the original (PDF) on 2010-06-02. Retrieved 2009-04-22.
- ^ "Swine: Product Information". Merial. Archived from the original on August 28, 2008. Retrieved April 22, 2009.
- ^ "Biodyl". Archived from the original on 2009-04-30.
- ^ "Refusal Details as Recorded in OASIS by FDA for Refusal 112-4397009-5/1/1/". Food and Drug Administration. Retrieved 2009-06-14.
- ^ Johnson, Craig (April 22, 2009). "Scrutiny in horse deaths falls on vitamins". CNN. Retrieved April 22, 2009.
- ^ a b "Una historia que aún no despejó las dudas: Avanzan las investigaciones por la muerte de los equinos: en las próximas horas habría resultados" (in Spanish). La Nacion Deportiva. April 22, 2009. Retrieved April 22, 2009.
- ^ Brian Haas, Missy Diaz (April 22, 2009). "Polo team captain: Vitamin likely killed 21 horses". South Florida Sun-Sentinel. Archived from the original on April 21, 2009. Retrieved April 22, 2009.
- ^ "Banned Vitamin Supplement May Have Caused Horse Deaths Polo Team Member Tells Newspaper Horses Received French-Made Drug". West Palm Beach News. April 22, 2009. Archived from the original on July 18, 2011. Retrieved April 24, 2009.
- ^ "Correction: Dead polo horses story". Associated Press via Google. April 23, 2009. Retrieved April 24, 2009. "In an April 22 story about 21 polo horses that died in Florida, The Associated Press reported erroneously that the Food and Drug Administration had refused to approve the French-made supplement Biodyl for use in the U.S. The manufacturer has never submitted the supplement for approval."
- ^ "CVM and Compliance". U.S. FDA Center for Veterinary Medicine. March 26, 2008. Archived from the original on January 15, 2008. Retrieved April 24, 2009.
- ^ Bill DiPaolo, Jane Musgrave (April 23, 2009). "Pharmacy: We made mistake on supplement given to dead polo ponies". The Miami Herald. Retrieved April 23, 2009. [dead link]
- ^ "Sec. 608.400 - Compounding of Drugs for Use in Animals (CPG 7125.40)". Compliance Policy Guidance. U.S. Food and Drug Administration. July 8, 2003. Archived from the original on January 15, 2008. Retrieved April 24, 2009.
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