Last December, the Food and Drug Administration (FDA) issued a warning to consumers and health care providers about prescription OSP products Visicol and Osmo Prep made by Salix Pharmaceuticals that had caused the serious kidney injury in patients. The agency expressed similar concern for over-the-counter OSP products made by C.B. Fleet such as Fleet Phospho-soda and Fleet Phospho-soda EZ-Prep Bowel Cleansing System.

Those products were deemed safe to use in lower doses; however, the products were routinely used in higher doses to prep the bowel before procedures. In May 2006, the FDA issued an alert identifying OSP bowel cleansing agents as a cause of acute phosphate nephropathy and provided guidelines to health care providers about higher risk patients and the need for adequate hydration.

While some patients may have been told by their doctors that use of OSP products contributed to their kidney injury, “the focal point is that there are people who experienced renal failure but never heard that their bowel cleansing product caused it,” Locklar says. This is especially true for patients who became ill prior to the 2006 warning, but also for patients who used the over-the-counter products for personal bowel clearing or over a long period of time as a laxative.

These patients may have only suffered a minor injury or received medical treatment quickly after becoming ill. These patients may not have been formally diagnosed with acute phosphate nephropathy but may have been told by their doctors that they have elevated levels of creatanine, BUN and other indicators that could lead to kidney problems in the future.

Locklar points out that the condition is limited to only OSP products, and that other bowel prep products, such as GO LIGHTLY and Miralax that do not contain OSP have not been linked to kidney injury. However, he says, “anybody experiencing a reaction to any products, we need to talk to them.”

SOURCE: Fleet Attorney › Some may not realize OSP caused kidney injury