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The sternest safety warnings are to be placed on drugs used before a type of internal medical examination after several patients suffered serious kidney damage, the US drugs watchdog said.
More than 20 patients taking a bowel cleansing oral phosphate drug prior to colonoscopies have developed severe kidney injuries.
The US Food and Drug Administration (FDA) said the new warning label will appear on boxes of Visicol and OsmoPrep – both prescription tablets made by the company Salix Pharmaceuticals.
The label warns that the drugs should be used with caution in patients older than 55, those who suffer from dehydration and kidney disease, and those who take medications that affect the kidneys.
A spokesman said: “There are many people who use these and use them fine. But there are people who are developing severe kidney injury, and it’s important we try and identify who is at risk.”
Copyright Press Association 2008
US Food and Drug Administration
