Oral Sodium Phosphate Linked to Kidney Problems
Mobile, Alabama
Oral Sodium Phosphate (OSP) products can be obtained either through a prescription or over-the-counter. Prescription products are stronger than store-bought products. OSP products are often used before a colonoscopy, to clear the bowel so that better imaging can be obtained.
In December, 2008, the FDA asked that a black box warning be placed on the labeling for prescription OSPs, warning of acute kidney failure associated with their use. The products are Visicol and Osmo Prep, made by Salix Pharmaceuticals.
The FDA also planned to change the labeling for over-the-counter bowel-cleansing products, though it stressed that their use as a laxative provides only low doses of OSPs and does not create any risk of kidney failure.
In response, the C.B. Fleet Company Inc., which manufactures many products related to bowel care, announced that it would recall some of its over-the-counter products. It recalled the Fleet Phospho-soda and Fleet Phospho-soda EZ-Prep Bowel Cleansing System. Then in February, 2009, Fleet stopped marketing its Fleet Prep Kit 1.
Acute Kidney Failure Possible But Rare
Incidence of acute kidney failure after use of products containing OSPs is rare. The director of the FDA’s Center for Drug Evaluation and Research, Janet Woodcock, M.D., said that, “Though rare, these are serious adverse events associated with the use of oral sodium phosphates — both prescription and over-the-counter products.”
Part of the problem is that although cases of kidney failure are rare, they have occurred, said Dr. Woodcock, “…in patients with no pre-existing health factors that would have put them at risk for developing kidney injury”.
She added, “We cannot rule out, however, that some of these patients were dehydrated prior to ingestion of OSP products or they did not drink sufficient fluids after ingesting OSP products.” If the body is dehydrated, there is not enough water to process the drug in the expected way, and its impact is therefore stronger.
However, the FDA’s warning about prescription OSP products, whether marketed by Fleet, Salix, or some other company, is their highest warning, and they are also warning the public about use of over-the-counter OSP products. If you use such a product, be sure to read the directions and follow them exactly.
If you or a loved one has suffered from kidney injury after using an OSP product, you may be entitled to fair compensation. Please contact our law office today. One of our defective product attorneys will be happy to give you a free consultation. Our office serves the Mobile, Alabama area.
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