Product News and Recalls

FDA Warns of Serious Injury from Sodium Phosphate Laxatives

On Wednesday, January 9, 2014, the FDA issued a warning concerning the potential for serious injury from laxatives containing sodium phosphate. Over-the-counter sodium phosphate drugs are used to treat constipation. They come in oral and rectal (enema) form. The recommended dose is one in 24 hours. These over-the-counter laxatives can cause serious kidney and heart injuries, even death, if more than one dose is taken over 24 hours.

The FDA has received reports that people taking more than the recommended dose have experienced severe dehydration and changes in the levels of electrolytes in the blood. This can result in serious adverse effects to organs such as the kidneys and heart, as well as death. There have been at least 13 reports of deaths associated with this form of medication.

Forms of Sodium Phosphate Laxatives


Laxatives that contain sodium phosphate are sold under the brand name “Fleet” by C.B. Fleet Co., Inc. Sodium phosphate laxatives also can be found in generic formulations and store brand versions. Prescription strength versions (such as Visicol and OsmoPrep from Salix Pharmaceuticals) have also been linked to kidney damage.

Previously, C.B. Fleet had recalled an over-the-counter medication, Fleet Phospho-Soda, because it was being sold at doses higher than the FDA permitted for over-the-counter oral laxatives containing sodium phosphate. Many people experienced serious kidney damage after using Fleet Phospho-Soda.