FDA to Add Strictest Warnings to Bowel-Cleansing Drugs
Thursday, December 11th, 2008Two prescription bowel-cleansing drugs commonly taken before colonoscopies will receive the sternest safety warnings available after nearly two dozen patients reported suffering severe kidney damage after taking the drugs, the Food and Drug Administration said.
The drugs, Visicol and OsmoPrep, are oral tablets made by Salix Pharmaceuticals. The FDA has received more than 20 reports of kidney failure in patients taking the tablets, known as oral phosphate products.
The drugs will now have new boxed warnings added to their packaging stating they are to be used with caution in patients older than 55, those who suffer from dehydration and kidney diseases, and those who are taking kidney medications.
The FDA first warned doctors and patients about potential kidney risks with the medications in 2006. A petition submitted to the agency last September called on regulators to place a boxed warning on the drugs.
Federal product safety regulators also are eyeing several brands of over-the-counter bowel cleansers, which are most often not taken under the direction or supervision of a physician and are more likely to be abused or used improperly than prescription drugs, the FDA said.
While many people use the drugs without any side effect, over-the-counter brands, including Fleet Phospho-soda, made by C.B. Fleet Company Inc., can result in serious kidney damage if not taken properly, officials said.
