Fleet Phospho-Soda Recall (2024)

FAQs

Is Fleet Phospho-soda still available? ›

Fleet no longer distributes OSP; however, generic versions of OSP are still available without prescription. OSP is also available by prescription in a pill form (Visicol, OsmoPrep). In both pill and liquid form, OSP is a hyperosmotic laxative that acts by drawing water into the gastrointestinal tract.

The risk of kidney damage from Fleet Phospho-Soda and other oral sodium phosphate products was initially reported in 2003. Three years later, the Food and Drug Administration released a report stating that oral sodium phosphate solutions were linked to a serious side effect known as acute phosphate nephropathy.

This medication may cause a condition known as laxative dependence, especially if it has been used regularly for a long time. In such cases, ongoing constipation and loss of normal bowel function may occur.

HALFLYTELY AND BISACODYL TABLETS BOWEL PREP KIT (20-mg bisacodyl) was indicated for the cleansing of the colon as preparation for colonoscopy in adults. Braintree informed FDA that it ceased to manufacture and market HALFLYTELY AND BISACODYL TABLETS BOWEL PREP KIT (20-mg bisacodyl) as of September 25, 2007.

On the morning of the procedure, an additional 1 ½ ounces of Fleet Phospho-Soda added to 4 ounces of water is ingested. It is recommended that the preparation be completed at least 3 hours prior to colonoscopy.

With chronic kidney disease, OSP should be avoided. For early chronic kidney disease, PEG or SPMC are acceptable. Cases with late chronic kidney disease without dialysis should be prescribed with PEG or PEGA. SPMC have a risk of hypermagnesemia in patients with kidney disease without dialysis.

Drug class: Laxatives

Avoid additional sodium phosphate-based purgative or enema products .

PHOSPHO-SODA is for use in adults. It works by producing bowel motions which cleanse the bowel. It usually works within 30 minutes, although it may take as long as 6 hours. Expect frequent liquid stools.

Recent studies have shown that the 4 liter polyethylene glycol with a split preparation is safe and effective for elderly patients, and is the preferred preparation for patients with medical comorbidites.

What is the best laxative to clean you out? ›

Instead, over-the-counter drugs such as polyethylene glycol (Miralax and generic), bisacodyl (Dulcolax laxative tablets and generic), or senna (Ex-Lax, Senokot, and generic) are a far better choice. They tend to work at least as well, often have more evidence for their safety, and are much cheaper.

The most commonly prescribed bowel prep formulas use a polymer-based laxative known as polyethylene glycol 3350 (PEG). This is a large molecule that can't be absorbed through your colon, causing a hyperosmotic effect. PEG formulas are typically in powder form designed to be mixed with large volumes of water.

In December 2008, CB Fleet Company, Inc. recalled their colonoscopy prep Fleet Phosphosoda after the FDA indicated it should not be available over-the-counter. For years Fleet promoted their laxative for use at high doses as a bowel prep without adequate warnings about the potential risk for kidney damage.

A recall for Fleet Phospho-soda was issued in December 2008, after the FDA issued a warning that the laxative should not be used as a bowel cleanser due to an increased risk of kidney damage side effects when taken at high doses.

PEG-based preps include GoLYTELY, MiraLAX, and MoviPrep. There are also sulfate-free PEG preps that some people prefer because they taste a little less salty. A few of these brands include NuLYTELY and TriLyte. (More details on the prep process below.)

Drug class: Laxatives

Avoid additional sodium phosphate-based purgative or enema products .

Different forms of Fleet (sodium phosphates enema) may be for use in different ages of children. Talk with the doctor before giving Fleet (sodium phosphates enema) to a child. Do not use other laxatives or stool softeners unless told to do so by the doctor.

Fleet Enema Extra Generic Name & Formulations

Monobasic sodium phosphate 19g, dibasic sodium phosphate 7g; per 197mL; latex-free; contains 4.4g sodium per enema.

PHOSPHO-SODA is for use in adults. It works by producing bowel motions which cleanse the bowel. It usually works within 30 minutes, although it may take as long as 6 hours. Expect frequent liquid stools.