Visicol Black Box Warning & Kidney Injury Lawsuit

Visicol (sodium phosphate monobasic monohydrate, USP, and sodium phosphate dibasic anhydrous, USP) Tablets are indicated for cleansing of the colon as a preparation for colonoscopy in adults 18 years of age or older.

On December 11, 2008 the U.S. Food and Drug Administration (FDA) announced that it was requiring the addition of a black box warning on oral sodium phosphate (OSP) products, including Visicol, regarding the risk of patients developing acute phosphate nephropathy.  Visicol is manufactured by Salix Pharmaceuticals, Ltd.  Salix also manufacturers OsmoPrep, another OSP, which also received a black box warning by the FDA on December 11, 2008.  The FDA also expressed concern about the use of related over-the-counter (OTC) laxatives such as Fleet Phospho-soda, which Fleet voluntarily recalled on December 11, 2008.

The FDA further required Salix to provide a Medication Guide for patients,

and implement a risk evaluation and mitigation strategy (REMS) to ensure that the benefits of the products outweigh the risk of acute phosphate nephropathy, a type of acute kidney injury.  The FDA also required that a post-marketing clinical trial be conducted to further assess the risk of acute kidney injury with use of Visicol.

Suffered An Injury – Seek a Legal Claim

If you or a loved one has used Visicol or another OSP and suffered from acute phosphate nephropathy or another serious Visicol side effect, you may be entitled to compensation.  Contact our Visicol lawyers today for a confidential, free, no-obligation case evaluation.