OsmoPrep Side Effects News
OsmoPrep, Visicol and Fleet Phospho Soda were over-the-counter products used before a colonoscopy. A colonoscopy is a medical procedure used to check the colon for pre-cancerous polyps with a camera. Prior to this procedure, it is necessary to clear the colon of feces so the camera can take clean pictures. In 2008, CB Fleet Company issued a Fleets Phospho Soda Recall after the FDA warned of serious kidney damage, including kidney failure, from the use of its product. The FDA was also concerned about Visicol and OsmoPrep side effects involving kidney injury and placed a black box warning on these products.
What warning did the FDA issue?
On December 11, 2008, the FDA issued a safety warning that stated in part as follows: “FDA has become aware of reports of acute phosphate nephropathy, a type of acute kidney injury, associated with the use of oral sodium phosphate products (OSP) for bowel cleansing prior to colonoscopy or other procedures. These products include the prescription products, Visicol and OsmoPrep, and OSPs available over-the-counter without a prescription as laxatives (e.g., Fleet Phospho-soda). In some cases when used for bowel cleansing, these serious adverse events have occurred in patients without identifiable factors that would put them at risk for developing acute kidney injury.” Following this warning, in December 2008, the Fleets Phospho Soda recall was issued.
What is acute phosphate nephropathy?
Acute phosphate nephropathy is a form of acute (meaning a rapid onset) kidney injury that is associated with deposits of calcium-phosphate crystals in the renal tubules that may result in permanent renal function damage. Acute phosphate nephropathy is a rare, serious adverse event that has been associated with the use of oral sodium phosphate products like Fleet Phospho Soda and OsmoPrep. Side effects involving kidney injury can result in long-term dialysis or kidney transplant in certain cases.
Who was at risk for acute phosphate nephropathy?
Consumers who took Fleet Phospho Soda, Visicol and OsmoPrep were potentially at risk for acute phosphate nephropathy. The FDA warned that there were also some individuals who had an increased risk of acute phosphate nephropathy following the use of Fleet Phospho Soda and OsmoPrep. This warning included people: who are over age 55; who are hypovolemic or have decreased intravascular volume; who have baseline kidney disease, bowel obstruction, or active colitis; and who are using medications that affect renal perfusion or function (such as diuretics, angiotensin converting enzyme [ACE] inhibitors, angiotensin receptor blockers [ARBs], and possibly nonsteroidal anti-inflammatory drugs [NSAIDs]).
What are my rights?
If you suffered an injury from the use of Fleet Phospho Soda or OsmoPrep side effects involving kidney damage, you have the right to pursue compensation for your damages. You should contact an OsmoPrep – Fleets Phospho Soda recall attorney as soon as possible.