After more than 20 people suffered serious kidney failures from taking bowel-cleansing oral sodium phosphate (OSP) drugs like OsmoPrep, the FDA ordered that such drugs must require a prescription and be labeled with a “black box” warning. Kidney failures have occurred due to severe dehydration brought on by the drug. In some cases, there were no other identifiable risk factors contributing to the injury.
Preparation for a Life-Saving Procedure Can be Life-Threatening
Bowel cleansing treatments are necessary to ensuring effective colonoscopies, a screening procedure that has been shown to save lives. They allow doctors to detect precancerous polyps and remove them, thereby preventing the deadly disease. Unsuspecting patients who chose drugs like OsmoPrep over other bowel-cleansing treatments because the pills were easier to take may suffer serious consequences.
OsmoPrep and other OSPs work by drawing fluid out of the body and out through the colon, creating a laxative effect. As the body empties of fluids, calcium-phosphate crystals may form in renal tubes, blocking the kidneys’ normal functioning and blood-cleansing capacity.
Severe Dehydration, Renal Tube Blockage and Kidney Failure
The severe dehydration brought on by the drug is called acute phosphate nephropathy. This serious side effect can permanently damage the kidneys, leaving individuals on dialysis or causing total kidney failure. The onset of the injury from OsmoPrep can occur within several hours of taking the drug up to 3 weeks later.
Consumers Were Not Adequately Warned of the Danger
Although the FDA issued warnings about the dangers of OsmoPrep shortly after Salix Pharmaceuticals began marketing the drug in 2006, black box warnings were not required for another two years. Salix continued to market the drug without adequately warning consumers of the danger.
FDA Video: Stronger Warnings for Bowel Cleansing Agents
Get Help from Our Experienced Drug Injury Attorneys
Those suffering serious kidney injuries after taking OsmoPrep and similar drugs may require dialysis for the remainder of their lives. In severe cases, they may need kidney transplants. If you were injured by an OSP drug, you need an experienced attorney on your side. Contact Childers, Schlueter & Smith today for a free evaluation of your case. We will work tirelessly to ensure you are fairly compensated for your injuries.