In spite of evidence linking oral sodium phosphate products such as Phospho-soda to irreversible kidney damage, Fleet waited more than two years after the FDA’s initial warning before it withdrew these products from the market
Austin, TX (Vocus) September 5, 2009
The law firm of Hissey Kientz, LLP is warning consumers to immediately stop using Fleet Phospho-soda products for any purpose, including bowel cleansing prior to a colonoscopy. In December 2008 the Food and Drug Administration warned that Phospho-soda products could cause irreversible damage to the kidneys. The C.B. Fleet Co. recalled its "Fleet Phospho-soda" and "Fleet Phospho-soda EZ-Prep Bowel Cleansing System" products shortly after the FDA warning.
"Despite the FDA's warnings about the side effects of Phospho-soda and Fleet's recall of these products, some colonoscopy patients are still being advised to take Phospho-soda for bowel cleansing," says attorney David Friend of Hissey Kientz. "Not only does this place patients at risk of kidney damage, but it directly contradicts the FDA's warning about the safety of these products."
Phospho-soda is a type of saline laxative known as an oral sodium phosphate (OSP), which has been sold over-the-counter since the late-19th century. During the 1990s, Fleet began marketing its Phospho-soda products to consumers for pre-colonoscopy bowel cleansing.
In May 2006, the FDA warned doctors and consumers of a link between a condition known as acute phosphate nephropathy and the use of OSPs such as Fleet’s Phospho-soda. Acute phosphate nephropathy is a type of acute renal failure caused by the formation of calcium phosphate crystals in the kidneys. These crystals can cause kidney function to become impaired, leading to irreversible kidney damage or kidney failure.
The FDA issued its warning after receiving several reports of patients who developed kidney failure and acute phosphate nephropathy after using an OSP such as Fleet Phospho-soda. The FDA warning stated that patients who were at an increased risk of acute phosphate nephropathy caused by Phospho-soda included the elderly, patients with kidney problems and those taking one of several types of medications, including diuretics, angiotensin converting enzyme (ACE) inhibitors, angiotensin receptor blockers (ARBs) and certain types of pain relievers.
In December 2008, the FDA issued a second warning about Phospho-soda, stating that the products should not be sold over-the-counter because of their risk for causing permanent kidney damage. As a result, Fleet issued a Phospho-soda recall, advising physicians to immediately stop recommending these products to patients.
"In spite of evidence linking oral sodium phosphate products such as Phospho-soda to irreversible kidney damage, Fleet waited more than two years after the FDA’s initial warning before it withdrew these products from the market," said Friend. "During this time, the company continued to promote Phospho-soda for bowel cleansing before a colonoscopy, encouraging patients to use this product despite evidence of an increased risk of kidney damage."
The FDA advised "Fleet Phospho-soda" and "Fleet Phospho-soda EZ-Prep Bowel Cleansing System" users to immediately stop using these products and to contact their doctor about an alternative form of treatment for pre-colonoscopy bowel cleansing.
About Hissey Kientz, LLP
Hissey Kientz, LLP (http://www.hkllp.com ) is currently accepting cases involving individuals who may have developed acute phosphate nephropathy as a result of a Fleet Phospho-soda product. Hissey Kientz, LLP also represents those who contracted mesothelioma or lung cancer as a result of asbestos exposure, and those injured by a fentanyl or Duragesic overdose, Digitek, Zicam, the Composix Kugel mesh patch, gadolinium MRI contrast dyes, Reglan, FELA railroad injury lawsuits, Raptiva, the Ortho Evra patch, Fen-Phen or "herbal Fen-Phen" products containing ephedra or ma huang, as well as other defective drugs and devices. To learn more about the firm and other drug cases, visit Hissey Kientz, LLP (http://www.hkllp.com) or call toll-free at (866) 275-4454.