Boxed Warnings Required for Visicol, OsmoPrep Labels

The FDA will require a boxed warning on Salix Pharmaceuticals’ Visicol and OsmoPrep labels because the products, used to prepare for colonoscopies, are associated with a risk of kidney injury called acute phosphate nephrology. The FDA also said last week it plans to amend the labeling conditions for OTC oral sodium phosphate products, commonly used as bowel cleansers.
Washington Drug Letter