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US FDA Takes Action on Fleet Phospho-Soda and All Oral Sodium Phosphate Laxatives

FDA Takes Action on Fleet Phospho-Soda AddThis Social Bookmark Button

Fleet Phospho-soda was available over the counter (OTC) without a prescription.

For several years, physicians have advised patients to use Fleet Phospho-soda Oral Saline Laxative and Fleet Phospho-soda EZ-PREP Bowel Cleansing System for complete bowel cleansing prior to colonoscopy, intestinal imaging, or other medical procedures. This was believed to be a safe and effective way to clear the bowel for examination. Unfortunately, it has proved to be extremely unsafe.

The mechanism of action is based on pulling liquid into the bowel and stimulating muscle movement to promote evacuation of the entire intestine. Clearing the bowel is necessary for clear visualization during gastroenterological exams. On their physician’s advice, patients utilized these drugs without being fully advised of the potential for serious, and potentially life threatening, adverse effects.

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General side effects of Fleet Phospho-soda were bloating and stomach pain, nausea and vomiting, dizziness, and headache. Warning labels did not address the most serious potential side effects. These effects included rectal bleeding, seizures, mouth sores, lethargy, drowsiness, decreased urination, abnormal heart rhythms and more. Severe dehydration could lead to many serious medical issues.

The most severe and potentially lethal adverse effect of Fleet Phospho-soda products is acute phosphate nephropathy, a condition in which crystals form in the tubules of the kidneys. These crystals damage the kidneys and impair their function. This impaired function can lead to increased toxins in the bloodstream. This condition can also lead to complete kidney failure and death.

In December of 2008, the US Food and Drug Administration (FDA) took action. The FDA Alert was issued on December 11, 2008 and stated that Fleet Phospho-soda, as well as other oral sodium phosphate products such as Visicol and OsmoPrep had caused acute phosphate nephropathy in patients who did not have other factors which would predispose them to kidney injury. The FDA required manufacturer of Visicol and OsmoPrep to add a Boxed Warning to the labeling of the products, warning users of the potential for serious injury associated with use. The FDA also required that manufacturer to implement a risk evaluation to determine whether the benefits of the products outweigh the risk of kidney damage as well as clinical trials to continue to assess the risks associated with use. The FDA suggested that OTC products, such as Fleets Phospho-soda, though safe for relief of constipation, should not be used for bowel cleansing in light of the risk for acute phosphate nephropathy.

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In response to the FDA Alert, C.B. Fleet chose to recall Fleet Phospho-soda products voluntarily so that oral sodium phosphate laxatives for bowel cleansing would be available to the public only with a valid prescription. Unfortunately, many have suffered irreversible kidney damage related to the use of these products. Those who have been diagnosed with acute phosphate nephropathy or renal failure after using the Fleet products should consult a fleet phospho-soda side-effects lawyer for legal advice.

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