FDA Adds Black Box To Bowel Clearing Drugs
1 CommentBy Ed Silverman // December 12th, 2008 // 8:00 am
The agency is adding the warnings to the drugs, which are used before colonoscopies, following reports of kidney damage in several patients. So far, the FDA has received more than 20 reports of a serious form of kidney failure among patients taking the bowel-cleansing drugs, known as oral phosphate products, the Associated Press writes.
The new labeling applies Visicol and OsmoPrep, which are prescription tablets made by Salix Pharmaceuticals. The drugs should be used with caution in patients older than 55, those who suffer dehydration and kidney disease, and those who take meds that affect kidneys.
“There are many people who use these and use them fine,” Charles Ganley, who heads FDA’s office of nonprescription products, told reporters on a teleconference. “But there are people who are developing severe kidney injury, and it’s important we try and identify who is at risk.”
The agency is also concerned about the risks of over-the-counter bowel cleansers, such as Fleet Phospho-soda, made by CB Fleet, though all the problems reported were connected with prescription products. FDA officials say many OTC phosphate products are labeled only to treat constipation, but patients use them at higher doses to clear the colon.
JimK
As an individual at risk for colon cancer I undergo colonoscopies every two years. I also am a strong proponent of the strongest possible warnings on adverse drug reactions.
However I have used Fleet Phosphate for years and have never had a problem. I also drink at least one gallon of fluids on the day before procedure. If an individual is performing a colon cleanse then it is imperative, if not plain common sense, that in order to avoid dehydration the individual must keep themselves fully hydrated. The article, although it alludes to improper patient use, does not fully address how many of the 20 serious incidents described did not follow the prescribing or OTC information.
Numerous colonoscopies are performed on a daily basis and the day before preparation is fairly consistent; to provide a Black Box Warning based on 20 incidents seems to me, at least, to be a little over the top and it may have the result of reducing the overall effectiveness of future Black Box Warnings.