Fleet Phospho-Soda Recalled
An over the counter drug used to cleanse the bowel before colonoscopy was recalled last week because of serious side effects including destruction of the kidneys. The product, Fleet Phospho-Soda, made by C.B. Fleet, Co., of Virginia, is involved in product liability lawsuits around the country. The law firm of Rheingold, Valet, Rheingold, Shkolnik & McCartney, LLP, has filed suit on behalf of a number of patients with kidney damage who used Fleet's product.
Fleet's recall followed the release of a Safety Alert by the Food and Drug Administration on Thursday warning consumers not to use over-the-counter laxatives, including Fleet's, in preparation for a colonoscopy due to the risk of kidney damage. The FDA will also now require prescription bowel cleansers, such as Visicol, to carry a black box warning about the risk of kidney damage. Since Fleet's is not a prescription product, it could not comply with the new FDA requirements, thus leading to the recall.
The lawsuits against Fleet allege that it improperly marketed Phospho-Soda at higher dosages than permitted by the FDA for over-the-counter oral laxatives containing sodium phosphate. "The FDA regulations are clear about the maximum daily dosage for these products, but Fleet continued for many years up until this recall to advise doctors and consumers to use twice the daily amount of its product that was permitted by the FDA," said Thomas P. Valet of the Rheingold, Valet law firm.
The safety of the higher dosages has never been demonstrated, according to Valet, who said that the higher dosage leads to deposits of calcium and phosphate in the kidneys, a condition known as nephrocalcinosis. In most cases, damage to the kidneys is permanent, requiring dialysis or even a transplant. The risk of kidney damage is increased in certain patients, according to Valet, including patients taking certain blood pressure medications or diuretics, and the risk of kidney damage increases with a patient's age. Valet said, however, that even those without a pre-existing risk factor can develop kidney failure after using Fleet's.
The link between kidney damage and Fleet's was first reported by a group of doctors in New York in 2003. Valet said that doctors from this group are working with his firm on behalf of injured patients and have been invaluable in helping prepare the cases against Fleet.