Certain Bowel Cleansers and the Risk of Kidney Damage

The U.S. Food and Drug Administration has added a Boxed Warning on two prescription oral sodium phosphate (OSP) products: Visicol and OsmoPrep. The Boxed Warning helps to warn consumers about the risk of acute phosphate nephropathy (a kind of acute kidney injury or damage). OSP products are routinely used to cleanse the bowel before colon examination (colonoscopy) and other medical procedures.

In addition, the FDA has also directed the makers of these products to

 develop a risk evaluation and mitigation strategy (REMS)

 distribute a Medication Guide to alert patients to the risk of acute kidney injury associated with these products

 conduct a postmarketing clinical trial to further assess this risk.

The agency is also concerned about the risks associated with over-the-counter (OTC) OSP products when used at higher doses for bowel cleansing. Available data do not show a risk of acute kidney injury when OTC OSP products are used at lower doses as laxatives. However, these products present the same risk as prescription OSP products when used for bowel cleansing.

The FDA recommends that consumers should not use OTC OSP products for bowel cleansing. The agency plans to amend the labeling conditions for OTC OSP products to address this concern with bowel cleansing use.

FDA Safety Advice

OSP products should NOT be used

 by children under 18 years of age

 in combination with other laxative products containing sodium phosphate

OSP prescription products should be used with caution by people who are

 over 55 years of age

 suffering from dehydration, kidney disease, acute colitis, or delayed bowel emptying

 taking certain medicines that affect kidney function, such as diuretics (fluid pills), angiotensin converting enzyme inhibitors (medications that lower blood pressure) angiotensin receptor blockers, (used to treat high blood pressure, heart or kidney failure) and possibly nonsteroidal anti-inflammatory drugs (similar to ibuprofen and other arthritis medications).

To learn more about the News Release and Updates provided by the U.S. Food and Drug Administration:

FDA Requires New Safety Measures for Oral Sodium Phosphate Products to Reduce Risk of Acute Kidney Injury
Risk associated with both prescription and over-the-counter (OTC) products (Press Release - December 11, 2008)

Kidney Risk Spurs Warning on Bowel Cleansers (Consumer Update - December 16, 2008)

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