Biodyl
Encyclopedia
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.
, in the muscle
, or in a vein
, depending on the species of animal. 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."
Composition:
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. A newspaper in Argentina reported 3 similar deaths of horses at an international competition in Uruguay.
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. 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. Also, the FDA may permit the importation of unapproved drugs for personal use for pets.
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. Compounding of drugs for use in animals is a subject of concern for the FDA.
Trademark
A trademark, trade mark, or trade-mark is a distinctive sign or indicator used by an individual, business organization, or other legal entity to identify that the products or services to consumers with which the trademark appears originate from a unique source, and to distinguish its products or...
of Merial
Merial
Merial is a multinational animal health company. It was formed as a joint venture between Merck & Co. and Sanofi-Aventis in 1997. Merial is now the animal health subsidiary of Sanofi-Aventis. Merial is a company leader in innovation, and provides an ample range with products to improve the...
for a dietary supplement
Dietary supplement
A dietary supplement, also known as food supplement or nutritional supplement, is a preparation intended to supplement the diet and provide nutrients, such as vitamins, minerals, fiber, fatty acids, or amino acids, that may be missing or may not be consumed in sufficient quantities in a person's diet...
used in animals. It is manufactured in two formulations: a powder for use in an individual animal's drinking water, and an injectable
Injection (medicine)
An injection is an infusion method of putting fluid into the body, usually with a hollow needle and a syringe which is pierced through the skin to a sufficient depth for the material to be forced into the body...
solution. The injectable solution is available by veterinary
Veterinarian
A veterinary physician, colloquially called a vet, shortened from veterinarian or veterinary surgeon , is a professional who treats disease, disorder and injury in animals....
prescription
Medical prescription
A prescription is a health-care program implemented by a physician or other medical practitioner in the form of instructions that govern the plan of care for an individual patient. Prescriptions may include orders to be performed by a patient, caretaker, nurse, pharmacist or other therapist....
in some countries and over the counter
Over-the-counter drug
Over-the-counter drugs are medicines that may be sold directly to a consumer without a prescription from a healthcare professional, as compared to prescription drugs, which may be sold only to consumers possessing a valid prescription...
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 skinSubcutaneous injection
A subcutaneous injection is administered as a bolus into the subcutis, the layer of skin directly below the dermis and epidermis, collectively referred to as the...
, in the muscle
Intramuscular injection
Intramuscular injection is the injection of a substance directly into a muscle. In medicine, it is one of several alternative methods for the administration of medications . It is used for particular forms of medication that are administered in small amounts...
, or in a vein
Intravenous therapy
Intravenous therapy or IV therapy is the infusion of liquid substances directly into a vein. The word intravenous simply means "within a vein". Therapies administered intravenously are often called specialty pharmaceuticals...
, depending on the species of animal. 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
Sodium selenite
Sodium selenite is a salt, a colourless solid, and the most common water-soluble selenium compound. It has the formulas Na2SeO3 and Na2SeO35 . Respectively, these are the anhydrous salt and its pentahydrate. This hydrated salt is the more common one...
and vitamin B 12) for debility, convalescence and myopathies."
Composition:
- Selenium (as sodium seleniteSodium seleniteSodium selenite is a salt, a colourless solid, and the most common water-soluble selenium compound. It has the formulas Na2SeO3 and Na2SeO35 . Respectively, these are the anhydrous salt and its pentahydrate. This hydrated salt is the more common one...
) - Potassium aspartate hemihydrateHydrateHydrate is a term used in inorganic chemistry and organic chemistry to indicate that a substance contains water. The chemical state of the water varies widely between hydrates, some of which were so labeled before their chemical structure was understood....
- Magnesium aspartateMagnesium aspartateMagnesium aspartate, the magnesium salt of aspartic acid, is a mineral supplement....
tetrahydrateHydrateHydrate is a term used in inorganic chemistry and organic chemistry to indicate that a substance contains water. The chemical state of the water varies widely between hydrates, some of which were so labeled before their chemical structure was understood.... - Methyl parahydroxybenzoate
- Propyl parahydroxybenzoate
- ExcipientExcipientAn excipient is generally a pharmacologically inactive substance used as a carrier for the active ingredients of a medication. In many cases, an "active" substance may not be easily administered and absorbed by the human body; in such cases the substance in question may be dissolved into or...
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".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."Implication in polo pony deaths
In April 2009, the sudden deaths of 21 polo poniesPolo pony
A polo pony is the term used for a horse used in the game of polo. They may be of any breed or combination of breeds, though many have a significant amount of Thoroughbred breeding. They are called "ponies", but that is in reference to their agile type rather than their size...
at Palm Beach International Polo Club
Palm Beach International Polo Club
The Palm Beach International Polo Club is one of the largest polo clubs in the world, and is located in Wellington, Florida. The club includes several natural grass polo fields, two of which are part of stadiums....
in Florida
Florida
Florida is a state in the southeastern United States, located on the nation's Atlantic and Gulf coasts. It is bordered to the west by the Gulf of Mexico, to the north by Alabama and Georgia and to the east by the Atlantic Ocean. With a population of 18,801,310 as measured by the 2010 census, it...
were attributed by a polo team captain to error or tampering in the team's supply of Biodyl. A newspaper in Argentina reported 3 similar deaths of horses at an international competition in Uruguay.
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. 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
Dietary supplement
A dietary supplement, also known as food supplement or nutritional supplement, is a preparation intended to supplement the diet and provide nutrients, such as vitamins, minerals, fiber, fatty acids, or amino acids, that may be missing or may not be consumed in sufficient quantities in a person's diet...
, 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. Also, the FDA may permit the importation of unapproved drugs for personal use for pets.
However, on April 23 a new concern emerged when a reputable pharmacy in Ocala, Florida
Ocala, Florida
Ocala is a city in Marion County, Florida. As of 2007, the population recorded by the U.S. Census Bureau was 53,491. It is the county seat of Marion County, and the principal city of the Ocala, Florida Metropolitan Statistical Area, which had an estimated 2007 population of 324,857.-History:Ocala...
disclosed that in compounding
Compounding
Compounding is the mixing of drugs by a compounding pharmacist to fit the unique needs of a patient...
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. Compounding of drugs for use in animals is a subject of concern for the FDA.
See also
- Adverse effectAdverse effectIn medicine, an adverse effect is a harmful and undesired effect resulting from a medication or other intervention such as surgery.An adverse effect may be termed a "side effect", when judged to be secondary to a main or therapeutic effect. If it results from an unsuitable or incorrect dosage or...
- Intravenous therapyIntravenous therapyIntravenous therapy or IV therapy is the infusion of liquid substances directly into a vein. The word intravenous simply means "within a vein". Therapies administered intravenously are often called specialty pharmaceuticals...
- ElectrolyteElectrolyteIn chemistry, an electrolyte is any substance containing free ions that make the substance electrically conductive. The most typical electrolyte is an ionic solution, but molten electrolytes and solid electrolytes are also possible....
- Oral rehydration therapyOral rehydration therapyOral rehydration therapy is a simple treatment for dehydration associated with diarrhoea, particularly gastroenteritis or gastroenteropathy, such as that caused by cholera or rotavirus. ORT consists of a solution of salts and sugars which is taken by mouth...
- Polo ponyPolo ponyA polo pony is the term used for a horse used in the game of polo. They may be of any breed or combination of breeds, though many have a significant amount of Thoroughbred breeding. They are called "ponies", but that is in reference to their agile type rather than their size...
- Endurance ridingEndurance ridingEndurance riding is an equestrian sport based on controlled long-distance races. It is one of the international competitions recognized by the FEI. There are endurance rides worldwide....