Recalls

Salix bowel cleaning products selling well despite FDA black box warning

Salix Pharmaceuticals, makers of gastrointestinal drugs, is reporting a first-quarter loss, however sales of the company’s products used to clean the bowel prior to colonoscopies enjoyed a 23 percent increase compared to first quarter 2008, according to The News & Observer.

“The bowel-cleansing market represents a dynamic and growing opportunity for Salix,” CEO Carolyn Logan said in a statement.

The company’s oral sodium phosphate (OSP) products Visicol and OsmoPrep are routinely prescribed for bowel cleansing prior to colonoscopies, radiographic procedures and surgeries. However the products fall under an FDA “black box warning” because the products have been linked to a rare adverse event known as phosphate nephropathy, a serious form of kidney failure. Posphate Nephropathy is often permanent and may require chronic dialysis.

The FDA also expressed concern over over-the-counter products often used for bowel cleansing, such as Fleet Phospho-soda and Fleet Accu-Prep. While using the products according to packaged instructions as a laxative does not pose a risk for kidney injury, physicians have often advised patients to use the products at higher doses to cleanse the bowel before medical procedures. Some customers were also using the products for regular bowel cleansing.

Following the FDA Alert, C.B. Fleet Company, Inc., manufacturer of several over-the-counter OSP solutions, voluntarily recalled its products and is making them available only by prescription.