Visicol is a sodium phosphate bowel cleanser that is prescribed by many physicians prior to a colonoscopy procedure or some other gastrointestinal examination. In December of 2008 Visicol’s manufacturer, Salix Pharmaceuticals, received a “black box” warning from the FDA that associates the potential for severe kidney damage with the use of the medication.
Visicol was approved by the FDA in 2000 for its current usage. In 2006 Salix Pharmaceuticals was approved for a new sodium phosphate product marketed under the name of OsmoPrep. The principal difference between the two products is that OsmoPrep is taken as a succession of pills in conjunction with the liquid of the patient’s choice. Visicol is a liquid that is ingested all at once.
FDA Concern in 2006
Also in 2006 the FDA put out a letter of concern to healthcare professionals in the form of a Science Paper that cautioned medical personnel about the potential relationship between sodium phosphate laxatives and kidney damage. Since that time the FDA has received additional reports of kidney damage associated with Visicol and OsmoPrep, leading to the demand for a black box warning to be printed on all packaging for these medications that details the potential for kidney problems.
Visicol can have a severe impact on kidneys, inducing a condition called acute phosphate nephropathy. This condition is brought on by the development of phosphate crystals in the renal tubes, resulting in permanent “kidney impairment.” The FDA has also charged Salix Pharmaceuticals with developing analytical guidelines for the prescription of Visicol or OsmoPrep.
FDA Warning in 2008
In the text of the FDA warning is an analytical tool requirement to be developed by the manufacture: “FDA is also requiring that the manufacturer develop and implement a risk evaluation and mitigation strategy (REMS), which will include a Medication Guide, to ensure that the benefits of these products outweigh the risk of acute phosphate nephropathy, and to conduct a postmarketing clinical trial to further assess the risk of acute kidney injury with use of these products.”
Visicol remains on the market, albeit with a strict series of requirements prior to prescription. The FDA is recommending that over-the-counter sodium phosphate products utilizing sodium phosphate as the active ingredient no longer be employed as bowel cleansers.
Legal Assistance for People with Visicol Kidney Damage
If you or a relative has suffered kidney problems as the result of using Visicol you should be in touch with an attorney who is experienced with medications that can be destructive to health. Fill out the brief Free Case Evaluation form on this page and one of our attorneys will be in touch with you to provide an in-depth analysis of your case at no charge.