Colonoscopy Laxatives May Cause Severe Kidney Injury
In December 2008, the FDA issued a warning against C.B. Fleet Company and its over-the-counter oral sodium phosphate (OSP) laxative, Fleet Phospho-soda. The laxative had been marketed as safe for double doses for colonoscopy bowel preps. However, higher doses of the product have been linked to acute phosphate nephropathy, a form of acute kidney injury, and various other side effects. Although it is rare, acute phosphate nephropathy includes calcium-phosphate crystalline deposits in the renal tubules and could lead to renal failure, dialysis, kidney transplant or death.
Visicol and OsmoPrep, the only two prescription OSPs, also carry some severe side effects such as kidney injury, rectal bleeding or chafing, seizures and arrhythmia, disorders affecting rhythmic heartbeat. They are often prescribed to patients as a bowel cleanser before colonoscopy, x-ray or surgery.
The manufacturers of Visicol and OsmoPrep, Salix Pharmaceuticals, are required by the FDA to place boxed warnings on the product labels. In addition to these warning labels, Salix Pharmaceuticals must issue a risk evaluation and mitigation strategy (REMS) in order to make sure that the product benefits outweigh the risks of acute phosphate nephropathy. They must also asses the products’ risk of acute kidney injury by organizing a post-marketing clinic trial.
Patients seriously injured by these OSPs could have a legal claim against the manufacturers and be compensated for their injuries, losses and emotional trauma. Manufacturers are under strict liability for products and marketing. The personal Missouri injury lawyers at Page Cagle have a wealth of knowledge and years of experience handling personal injury cases in Missouri. Contact our offices today at (866) 620-5757 for a free consultation.
