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Longtime laxative no longer available over the counter
June 23rd, 2009 by Jennifer Walker-Journey
Laxatives, like Fleet Phospho-Soda, an oral sodium phosphate (OSP) product, have been sold over the counter for more than a century, so it may come as some surprise that these products suddenly fall under a Food and Drug Administration (FDA) warning that links the use of OSPs to a serious kidney injury.
Since the late 1800s, Fleet Phospho-soda has been used as an over-the-counter medication to treat constipation. However, in the 1990s, doctors began prescribing Fleet Phospho-soda as a bowel cleansing agent to be used prior to colonoscopies and other gastrointestinal procedures. It is believed that this practice began at the direction of C.B. Fleet Company, the makers of numerous over-the-counter laxatives, and that C.B. Fleet Company informed doctors that patients could safely and effectively use the product in this manner.
Use of Fleet Phospho-soda as a bowel cleansing agent required doubling and, in some cases, tripling the amount of product that was needed for constipation in order to completely clean the bowels for the planned procedures. Use of the product in this nature caused some persons to develop phosphate toxicity and resulted in renal or kidney failure and injury.
It is unknown how many people have actually suffered renal failure from these products, but according to Ben Locklar, shareholder with Beasley Allen, the medical community did not learn about a possible connection between OSPs and renal failure until it was too late for many people. Though C.B. Fleet Company had received a number of adverse event reports associated with its products, the company was slow in notifying physicians and users of the dangers associated with the products’ use. In 2003, an article appeared in the New England Journal of Medicine, documenting the case of a woman with acute phosphate nephropathy following OSP bowel cleansing. Other articles making similar connections followed over the ensuing months.
Following additional study and review by physicians, and at the FDA’s urging, C.B. Fleet Company modified its label to encourage adequate hydration to help flush the product from the body and to help reduce the risks to users’ kidneys. In May 2006, the FDA issued an alert that identified OSP bowel cleansing agents as a cause of acute phosphate nephropathy (or nephrocalcinosis) and provided guidelines to health care providers about the higher risk patients and the need for adequate hydration.
Despites the FDA’s efforts, additional reports of renal failure were received, resulting in oral Fleet Phospho-soda being pulled from the market. Subsequently, the FDA required a warning for Visicol and Osmoprep, two other OSPs. These products are now only available by prescription.
Kidney failure may not manifest itself until months after a person has taken an OSP. If a person suffers renal failure after using one of these products, he/she should consider that the OSP played a role in the injury and should discuss this possibility with his/her physician. A medical test can help to make this determination.
As a result of the use of these dangerous products, untold numbers of people have suffered renal or kidney injury. To date, a large number of cases have been filed against Fleet Phospho-soda. It is anticipated that more cases will be filed as physicians and patients are made aware that renal failure could have resulted from the use of an OSP.
