In December 2008, C.B. Fleet Company recalled its “Fleet Phospho-soda” and “Fleet Phospho-soda EZ-Prep Bowel Cleansing System” products after they were linked to a type of permanent kidney damage that could lead to acute renal failure. The decision to issue the Phospho-soda recall came shortly after the Food and Drug Administration issued a safety alert for the bowel cleansing products following several reports of acute phosphate nephropathy, a condition which causes permanent and irreversible damage to the kidneys.
Phospho-soda is a type of saline laxative that has been sold over-the-counter since the late 19th century. During the early 1990s, Fleet began to market its Phospho-soda products for bowel cleansing before a colonoscopy. However, in order for the products to work properly for this use, Fleet had to recommend that patients take double the dose.
Over the next several years, health experts in the United States and Canada issued a number of medical reports linking the use of Phospho-soda before a colonoscopy to kidney damage, including side effects caused by renal failure and acute phosphate nephropathy. Despite these warnings—and the fact that just a single use of Phospho-soda could cause kidney damage within 60 days of use—Fleet took no action to withdraw Phospho-soda or warn consumers about its dangers.
The FDA issued a warning in 2006 about the risk of acute kidney failure in patients who used Phospho-soda for bowel cleansing. The warning stated that elderly patients, patients with kidney disease and those taking medications which could affect kidney function—including ACE inhibitors, angiotensin receptor blockers and some pain relief drugs—were at an increased risk of renal failure caused by acute phosphate nephropathy when using Phospho Soda.
In December 2008, the FDA issued a safety alert stating that Fleet’s Phospho-soda products should be available by prescription only due to the risk of kidney injuries. As a result of the safety alert, Fleet issued a recall notice for both of its Phospho-soda products and directed patients and physicians to stop using them for bowel cleansing.
If you have experienced side effects such as kidney damage or renal failure after using a Fleet Phospho Soda product, including acute phosphate nephropathy, contact the law office of Hissey Kientz to learn more about your legal rights. You can reach us by calling toll-free at (866) 275-4454, or by filling out a free case evaluation form to the right of this page.