FDA Home Page | Search FDA Site | FDA A-Z Index | Contact FDA
Consumer Update |
The Food and Drug Administration (FDA) has acted to reduce the risk of acute kidney injury from oral sodium phosphate (OSP) products. These products are routinely used as bowel cleansers before colon examinations and other medical procedures.
The agency is adding a Boxed Warning to two prescription OSP products: Visicol and OsmoPrep. The warning addresses the risk of a kidney injury known as acute phosphate nephropathy.
FDA has also directed the makers of Visicol and OsmoPrep to
FDA is equally concerned about the risks associated with over-the-counter (OTC) OSP products (e.g., Fleet Phospho-soda) when they are used at higher doses for bowel cleansing.
The available data show no risk of acute kidney injury when OTC products are used at the lower doses as laxatives. But these products present the same risks as prescription OSP products when used for bowel cleansing.
FDA is recommending that consumers not use OTC OSP products for bowel cleansing. The agency plans to amend the labeling conditions for these products.
OSP products should NOT be used
OSP prescription products should be used with caution by people who are
Serious side effects or quality problems associated with these products can be reported to FDA's MedWatch Adverse Event Reporting program online www.fda.gov/MedWatch/report.htm, or by mail, fax, or phone. (See FDA Press Release, available at the link below, for details.)
This article appears on FDA's Consumer Health Information Web page (www.fda.gov/consumer), which features the latest updates on FDA-regulated products. Sign up for free e-mail subscriptions at www.fda.gov/consumer/consumerenews.html.
FDA Press Release
http://www.fda.gov/bbs/topics/NEWS/2008/NEW01923.html
Date Posted: December 16, 2008