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.
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]
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]
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]
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]
The United States Food and Drug Administration is a Federal agency of the Department of Health and Human Services. The FDA is responsible for protecting and promoting public health through the control and supervision of food safety, tobacco products, dietary supplements, prescription and over-the-counter pharmaceutical drugs (medications), vaccines, biopharmaceuticals, blood transfusions, medical devices, electromagnetic radiation emitting devices (ERED), cosmetics, animal foods & feed and veterinary products.
Pantothenic acid, also called vitamin B5 is a water-soluble B vitamin and therefore an essential nutrient. All animals require pantothenic acid in order to synthesize coenzyme A (CoA) – essential for fatty acid metabolism – as well as to in general synthesize and metabolize proteins, carbohydrates, and fats.
A dietary supplement is a manufactured product intended to supplement the diet when taken by mouth as a pill, capsule, tablet, or liquid. A supplement can provide nutrients either extracted from food sources or synthetic, individually or in combination, in order to increase the quantity of their consumption. The class of nutrient compounds includes vitamins, minerals, fiber, fatty acids and amino acids. Dietary supplements can also contain substances that have not been confirmed as being essential to life, but are marketed as having a beneficial biological effect, such as plant pigments or polyphenols. Animals can also be a source of supplement ingredients, as for example collagen from chickens or fish. These are also sold individually and in combination, and may be combined with nutrient ingredients. In the United States and Canada, dietary supplements are considered a subset of foods, and are regulated accordingly. The European Commission has also established harmonized rules to help insure that food supplements are safe and properly labeled.
An epinephrine autoinjector is a medical device for injecting a measured dose or doses of epinephrine (adrenaline) by means of autoinjector technology. It is most often used for the treatment of anaphylaxis. The first epinephrine autoinjector was brought to market in 1983.
A prescription drug is a pharmaceutical drug that legally requires a medical prescription to be dispensed. In contrast, over-the-counter drugs can be obtained without a prescription. The reason for this difference in substance control is the potential scope of misuse, from drug abuse to practicing medicine without a license and without sufficient education. Different jurisdictions have different definitions of what constitutes a prescription drug.
Stanozolol, sold under many brand names, is an androgen and anabolic steroid (AAS) medication derived from dihydrotestosterone (DHT). It is used to treat hereditary angioedema.[12] It was developed by American pharmaceutical company Winthrop Laboratories in 1962, and has been approved by the U.S. Food and Drug Administration for human use, though it is no longer marketed in the USA. It is also used in veterinary medicine. Stanozolol has mostly been discontinued, and remains available in only a few countries. It is given by mouth in humans or by injection into muscle in animals.
Cannabidiol (CBD) is a phytocannabinoid discovered in 1940. It is one of 113 identified cannabinoids in cannabis plants and accounts for up to 40% of the plant's extract. As of 2019, clinical research on CBD included studies of anxiety, cognition, movement disorders, and pain, but there is still insufficient high-quality evidence that it is effective for these conditions.
The United States Federal Food, Drug, and Cosmetic Act, is a set of laws passed by Congress in 1938 giving authority to the U.S. Food and Drug Administration (FDA) to oversee the safety of food, drugs, medical devices, and cosmetics. A principal author of this law was Royal S. Copeland, a three-term U.S. Senator from New York. In 1968, the Electronic Product Radiation Control provisions were added to the FD&C. Also in that year the FDA formed the Drug Efficacy Study Implementation (DESI) to incorporate into FD&C regulations the recommendations from a National Academy of Sciences investigation of effectiveness of previously marketed drugs. The act has been amended many times, most recently to add requirements about bioterrorism preparations.
The United States Food and Drug Administration's Investigational New Drug (IND) program is the means by which a pharmaceutical company obtains permission to start human clinical trials and to ship an experimental drug across state lines before a marketing application for the drug has been approved. Regulations are primarily at 21 C.F.R. 312. Similar procedures are followed in the European Union, Japan, and Canada.
Off-label use is the use of pharmaceutical drugs for an unapproved indication or in an unapproved age group, dosage, or route of administration. Both prescription drugs and over-the-counter drugs (OTCs) can be used in off-label ways, although most studies of off-label use focus on prescription drugs.
Meloxicam, sold under the brand name Mobic among others, is a nonsteroidal anti-inflammatory drug (NSAID) used to treat pain and inflammation in rheumatic diseases and osteoarthritis. It is used by mouth or by injection into a vein. It is recommended that it be used for as short a period as possible and at a low dose.
Sodium selenite is the inorganic compound with the formula Na2SeO3. This salt is a colourless solid. The pentahydrate Na2SeO3(H2O)5 is the most common water-soluble selenium compound.
In the field of pharmacy, compounding is the preparation of a custom formulation of a medication to fit the unique need of a patient which cannot be met with commercially available products. This may be done for medical reasons, such as to be administered by a different route, to avoid a non-active ingredient the patient is allergic to, or to provide an exact dose that isn't commercially available. Medically necessary compounding is referred to as "traditional" compounding. Compounding may also be done for optional reasons, such as preference of flavor or texture, or dietary restrictions.
Sodium selenate is the inorganic compound with the formula Na
2SeO
4, not to be confused with sodium selenite. It exists as the anhydrous salt, the heptahydrate, and the decahydrate. These are white, water-soluble solids. The decahydrate is a common ingredient in multivitamins and livestock feed as a source of selenium. The anhydrous salt is used in the production of some glass. Although the selenates are much more toxic, many physical properties of sodium selenate and sodium sulfate are similar.
B&O Supprettes is the brand name for a prescription medication containing powdered opium and belladonna alkaloids in a suppository form. They are indicated for the treatment of moderate to severe pain from urethral spasm, and for extending the interval(s) between injections of opiates. The drug has various "off label" uses, including renal colic, intestinal cramps, tenesmus and diarrhea. They are also often prescribed after urinary bladder surgery. B&O Supprettes was unique in the United States because they were the only drug containing opium that is for suppository use sold in the US and, in fact, one of the very few medications that contains opium in any form in the US along with paregoric and opium tincture (laudanum).
An emergency use authorization (EUA) in the United States is an authority granted to the Food and Drug Administration (FDA) under sections of the Federal Food, Drug, and Cosmetic Act as added to and amended by various Acts of Congress, including by the Pandemic and All-Hazards Preparedness Reauthorization Act of 2013 (PAHPRA). It does not constitute approval of the drug in the full statutory meaning of the term, but instead authorizes FDA to facilitate availability of an unapproved product, or an unapproved use of an approved product, during a declared state of emergency from one of several agencies or of a "material threat" by the Secretary of Homeland Security.
The McGuff Companies consist of three entities: a wholesale distributor of medical supplies, a compounding pharmacy, and a pharmaceutical manufacturing facility which produces sterile injectables for national and international distribution. The McGuff Companies have been featured in The International Journal of Pharmaceutical Compounding (IJPC).
A New England Compounding Center meningitis outbreak that began in September 2012 sickened 798 individuals and resulted in the deaths of more than 100 people. In September 2012, the Centers for Disease Control and Prevention, in collaboration with state and local health departments and the Food and Drug Administration (FDA), began investigating a multistate outbreak of fungal meningitis and other infections among patients who had received contaminated steroid injections from the New England Compounding Center (NECC) in Framingham, Massachusetts. The NECC was classified as a compounding pharmacy. The traditional role of compounding pharmacies is to make drugs prescribed by doctors for specific patients with needs that can't be met by commercially available drugs.
The Food and Drug Administration Safety and Innovation Act of 2012 (FDASIA) is a piece of American regulatory legislation signed into law on July 9, 2012. It gives the United States Food and Drug Administration (FDA) the authority to collect user fees from the medical industry to fund reviews of innovator drugs, medical devices, generic drugs and biosimilar biologics. It also creates the breakthrough therapy designation program and extends the priority review voucher program to make eligible rare pediatric diseases. The measure was passed by 96 senators voting for and one voting against.
The Dietary Supplement Health and Education Act of 1994 ("DSHEA"), is a 1994 statute of United States Federal legislation which defines and regulates dietary supplements. Under the act, supplements are effectively regulated by the FDA for Good Manufacturing Practices under 21 CFR Part 111.
Wikinews has related news: |