OsmoPrep and Visicol makers answer to FDA regarding acute kidney injury in colonoscopy patients

The FDA has required the makers (Salix Pharmaceuticals ) of OsmoPrep and Visicol to conduct a risk evaluation and mitigation strategy that is designed to manage the known serious risks associated with both of their oral-sodium phosphate products .

Risk Evaluation and Mitigation Strategies (REMS) are designed to manage a known or potential serious risk associated with a drug or biological product.  A REMS will be required of Salix to ensure that the benefits of the Osmoprep and Visicol coloscopy preps outweigh the potential for acture kindey injury (acute phosphate nephropathy).

Salix Pharmaceuticals will be required to provide the FDA with a:

Medication guide
Patient package insert
A communication plan
Elements to assure safe use
Implementation system
A timetable for assessment of the REMS

If you have suffered an acute kidney injury following the use of a colonoscopy prep drug, it's critical that you contact an attorney to protect your legal rights for a possible recovery in a class-action lawsuit.