Sodium phosphate is used in a number of products that are meant for use as bowel cleansers prior to a colonoscopy. A number of pharmaceutical companies have products on the market that are varying formularies for bowel cleansers, all of which utilize sodium phosphate.
There are three principal variation on sodium phosphate; principally differentiated by the type of sodium molecule and the level of sodium used. Sodium phosphates are used as an emulsifier in food additives in order to prevent oil separation in prepared and packaged foods. Sodium phosphates in another form are used as additives for cleaning products.
OsmoPrep and Kidney Damage
OsmoPrep is an oral medication with sodium phosphate as the principal active ingredient, provided to patients a day or so prior to a colonoscopy examination. Recently, this product was identified by the FDA as carrying the risk of kidney damage.
In December of 2008 the FDA issued a “black box warning” for OsmoPrep and other sodium phosphate laxatives that noted evidence of severe kidney damage to individuals who have used this product prior to a colonoscopy or some other gastrointestinal examination. The FDA instructed OsmoPrep’s manufacturer, Salix Pharmaceuticals, Inc. to include a warning on the packaging for the product that cautions against the possible occurrence of severe kidney damage.
The FDA spells out the potential impact of oral sodium phosphate (OSP) usage in their warning: “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…”
Prior Concern from the FDA
The agency issued a note of concern to healthcare professionals in the form of an FDA Science Paper in May of 2006. Since that time additional cases of renal nephropathy associated with sodium phosphate bowel cleansers have resulted in the insistence on a black box warning for OsmoPrep, and a demand for further post-marketing research by the pharmaceutical company.
Legal Assistance for OsmoPrep Kidney Damage
If you or a relative have suffered kidney problems as the result of using OsmoPrep or some other sodium phosphate bowel cleanser you should consult with an attorney experienced in seeking compensation from pharmaceutical companies who market dangerous products. Fill out the Free Case Evaluation form on this page and you will be contacted by a knowledgeable attorney who will give you an in-depth assessment of your case at no charge.