More than 50 lawsuits have been filed across the country claiming that Fleet Phospho-soda, a laxative made by C.B. Fleet Co. Inc. of Lynchburg, Va.,caused serious kidney damage, sometimes leading to death, reports the Associated Press. According to the lawyers that filed the suits, the Food and Drug Administration lists Phospho-soda as safe when used as a single-dose laxative, but in the early 1990s the company began promoting a double-dose regimen for people about to undergo colonoscopies and surgical procedures. The drug is used to flush out the bowels before these procedures. The AP reports that the FDA never certified the double-dose regimen.
The FDA issued an alert in May 2006 warning about 21 documented cases of kidney failure associated with the use of oral sodium phosphate solutions such as Phospho-soda and its generic competitors. The current FDA information sheet about oral sodium phosphate products renews the May 2006 warning:
A rare, but serious form of kidney failure has been associated with the use of oral sodium phosphate (OSP) products (e.g., Fleet Phospho-soda solution, Fleet Accu-Prep solution, and Visicol tablets) for bowel cleansing. No cases of kidney failure have been associated with a recently approved OSP product (OsmoPrep tablets) for bowel cleansing.
C.B. Fleet Co. Inc. denies that the double-dose regimem is unreasonably dangerous when used in patients with proper hydration and that the risks associated with the solution are outweighed by the benefits.
While there is always a risk-benefit analysis performed with the prescription of any drug, it is imperative that manufacturers make the risks well known to doctors and their patients or the risk-benefit analysis is a useless exercise. These court cases will expose whether the manufacturer of sodium phosphate solutions for bowel cleansing failed to disclose what it knew about the risks to patients.