New Warning for Oral Sodium Phosphate Bowel Cleansing Products

 

The FDA has informed the public about reports of sudden kidney injury linked to the use of oral sodium phosphate products for bowel cleansing (for example, when used to clean out the bowels before a colonoscopy). These products include the prescription products, Visicol and OsmoPrep, and other products available over-the-counter (OTC) without a prescription when used at higher doses, such as Fleet Phospho-soda.

Patients at greatest risk for acute kidney problems with the use of these bowel cleansing products include patients who are older than 55, are dehydrated, have a history of kidney problems, have a history of bowel problems or take certain medications that affect kidney function such as diuretic (water pill), angiotensin converting enzyme (ACE) inhibitors (medications that lower blood pressure), angiotensin receptor blockers (ARBs, used to treat high blood pressure, heart or kidney failure), and possibly nonsteroidal anti-inflammatory drugs (NSAIDS, like ibuprofen or other arthritis medications).

The FDA is requiring Visicol and OsmoPrep, the two products available by prescription, to contain a Boxed Warning about the risk of developing kidney problems. In light of the risk of acute kidney problems, over-the-counter oral sodium phosphate products like Fleet Phospho-soda should not be used for bowel cleansing. However, the available data do not show a risk of acute kidney injury when these OTC products are used at laxative doses.

What does this mean?

The FDA recommends that consumers only use bowel cleansing products, like Visicol, OsmoPrep and Fleet Phospho-soda under the guidance of a healthcare professional.

If you are going to use these products, the following steps may help reduce your risk of developing sudden kidney problems: (a) review your medical history and medication list with your healthcare professional prior to using a bowel cleansing product; (b) stay hydrated by drinking large amounts of clear liquids while taking the bowel cleansing product; (c) watch for signs of kidney problems such as a general feeling of not being well, tiredness, drowsiness, decreased amount of urine, and swelling of the ankles, feet and legs and contact your doctor immediately if any of these signs develop; and (d) have your doctor follow your kidney function closely, especially if you are at increased risk of developing this side effect.

If you are using over-the-counter products like Fleet Phospho-soda, at the higher dose for laxative purposes, you should contact your doctor to make sure you are using them safely.

If you have any questions about this alert, please follow up with your healthcare provider.

Created on December 13, 2008

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