Phospho soda
Encyclopedia
Phospho soda is an 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...

 saline laxative
Laxative
Laxatives are foods, compounds, or drugs taken to induce bowel movements or to loosen the stool, most often taken to treat constipation. Certain stimulant, lubricant, and saline laxatives are used to evacuate the colon for rectal and/or bowel examinations, and may be supplemented by enemas under...

 formerly produced by the C.B. Fleet Company in Lynchburg, Va. Phospho soda consisted mostly of monobasic sodium phosphate monohydrate and dibasic sodium phosphate heptahydrate. Phospho soda was often taken in a double dose or 2 45mL doses to prepare for colonoscopy
Colonoscopy
Colonoscopy is the endoscopic examination of the large bowel and the distal part of the small bowel with a CCD camera or a fiber optic camera on a flexible tube passed through the anus. It may provide a visual diagnosis and grants the opportunity for biopsy or removal of suspected...

.

An amount of Phospho soda (normally 1.5fluid ounce
Fluid ounce
A fluid ounce is a unit of volume equal to about 28.4 mL in the imperial system or about 29.6 mL in the US system. The fluid ounce is distinct from the ounce, which measures mass...

 or 45 ml) is usually mixed with water or other clear liquids such as ginger ale
Ginger ale
Ginger ale is a carbonated soft drink flavored with ginger. Dr. Thomas Cantrell, an American apothecary and surgeon, claimed to have invented ginger ale and marketed it with beverage manufacturer Grattan and Company. Grattan embossed the slogan "The Original Makers of Ginger Ale" on its bottles...

. This preparation usually results in a bowel movement anywhere from 30 minutes to 6 hours after it is taken. Phospho soda is also available in flavors to make it more palatable.

Safety issues

The use of Phospho soda has been known to lead to Acute Phosphate Nephropathy. According to the U.S. Food and Drug Administration (FDA), "Acute phosphate nephropathy is a form of acute kidney injury that is associated with deposits of calcium-phosphate crystals in the renal tubules that may result in permanent renal function impairment. Acute phosphate nephropathy is a rare, serious adverse event that has been associated with the use of OSPs. The occurrence of these events was previously described in an Information for Healthcare Professionals sheet and an FDA Science Paper issued in May 2006. Additional cases of acute phosphate nephropathy have been reported to FDA and described in the literature since these were issued."

Fleet’s Phospho-soda products have been linked to kidney damage since the 1990s.

On December 11, 2008, the FDA issued a Safety Alert stating that "FDA has become aware of reports of acute phosphate nephropathy, a type of acute kidney injury, associated with the use of oral sodium phosphate products (OSP) for bowel cleansing prior to colonoscopy or other procedures. These products include the prescription products, Visicol and OsmoPrep, and OSPs available over-the-counter without a prescription as laxatives (e.g., Fleet Phospho-soda). In some cases when used for bowel cleansing, these serious adverse events have occurred in patients without identifiable factors that would put them at risk for developing acute kidney injury ... The agency is equally concerned about the risks associated with the use of OSP products that are available over-the-counter (OTC), for example, Fleet Phospho-soda, when used at higher doses for bowel cleansing."

Use as a laxative

Phospho soda can be used for a general laxative, but is not recommended. The dosage then is best cut in half and used only once instead of twice.

Phospho soda works by drawing liquid from the body into the colon
Colon (anatomy)
The colon is the last part of the digestive system in most vertebrates; it extracts water and salt from solid wastes before they are eliminated from the body, and is the site in which flora-aided fermentation of unabsorbed material occurs. Unlike the small intestine, the colon does not play a...

, therefore it can cause severe dehydration
Dehydration
In physiology and medicine, dehydration is defined as the excessive loss of body fluid. It is literally the removal of water from an object; however, in physiological terms, it entails a deficiency of fluid within an organism...

, especially if not used properly. Usage in this context is highly recommended to be performed only with a doctor's knowledge and consent.

Pre-colonoscopy usage

When Phospho soda is taken for colonoscopy prep the dose is usually 1.5 fluid ounces, twice in one day (3 oz total) usually 6 hours apart and is to be mixed with equal parts water (or other clear liquid) and then followed by 8 oz water. It will create very loose, {liquid} stool within 1/2 hour to 6 hours, usually in about one hour.

A 2007 study showed that in patients with decreased renal function
Renal function
Renal function, in nephrology, is an indication of the state of the kidney and its role in renal physiology. Glomerular filtration rate describes the flow rate of filtered fluid through the kidney...

, Phospho soda may worsen renal impairment compared to polyethylene glycol
Polyethylene glycol
Polyethylene glycol is a polyether compound with many applications from industrial manufacturing to medicine. It has also been known as polyethylene oxide or polyoxyethylene , depending on its molecular weight, and under the tradename Carbowax.-Available forms:PEG, PEO, or POE refers to an...

-based laxatives. In patients without kidney problems, no difference was observed.

Litigation

Since late 2004, there has been a great deal of litigation in both state and federal courts alleging renal injury following the use of Fleet Phospho-Soda. On June 23, 2009, the United States Judicial Panel on Multi District Litigation consolidated all federal Oral Sodium Phosphate Solution lawsuits to the Northern District of Ohio, before the Honorable Ann Aldrich. Additional documents from Phospho-Soda lawsuits have been published at the website DangerousDrugs.us
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