Following the reports of kidney damage in
people who had used some sodium-based bowel cleansing products before
colonoscopies, the U.S. Food and Drug Administration said it would require the
warnings on Salix Pharmaceuticals Ltd’s Visicol and OsmoPrep prescription
products to caution about acute phosphate nephropaty, a type of acute kidney
injury.
The agency said it received more than 20
reports of a serious form of kidney failure among patients taking the
bowel-cleansing drugs, known as oral phosphate products. Three of those cases
were confirmed by biopsy. The injury may lead to permanent kidney damage, the
agency said. Agency’s regulators said that in some cases, the injuries occurred
in patients with no pre-existing health factors that would have put them at
risk of developing permanent kidney damage.
The FDA is “equally concerned” about the
risks associated with the nonprescription oral sodium phosphate products when
they are used at higher doses for bowel cleansing, according to its statement. Drinking
plenty of fluids can help prevent the injuries, according to the FDA.
The agency, however, admitted that some of
those patients might have been dehydrated prior to ingesting of OSP products,
or might not have followed directions outlined on the drugs, which instruct
patients to drink up to half a gallon of water with the tablets.
The FDA recommends that people use caution
with those products if they are in the following risk groups: people older than
50; people suffering from dehydration, kidney disease, acute colitis, or
delayed bowel emptying; people taking medications that influence kidney
function, such as diuretics, ACE inhibitors, angiotensin receptor blockers, and
possibly nonsteroidal anti-inflammatory drugs.
The agency advised consumers not to use over-the-counter
bowel cleansers, though all the problems reported to the FDA were related to
the use of prescription products.
Regular colonoscopies are recommended for
all people over the age of 50 and for those who have some pre-existing
conditions that put them at risk of developing colon cancer. Studies have shown
that regular screening for colorectal cancers could reduce deaths from the
disease by catching it in the earliest stages, when the disease is often
asymptomatic.
Doctors say the cancer has a 90 percent
cure rate when caught in the earliest stages, but people avoid the standard
procedure because it is unpleasant. The traditional colonoscopy method involves
inserting a long and flexible tube in a patient’s large intestine (rectum and
colon). A cleansing of the bowels is needed before the procedure. A small video
camera is attached to the colonoscope so that your doctor can take pictures or
video of the large colon. The test helps find ulcers, polyps, tumors and areas
of inflammation or bleeding.
Colon cancer, also called colorectal cancer, is the second leading cause
of cancer death in the United
States and the third most common one in the
Western world. The disease includes cancerous growths in the colon, rectum and
appendix. Statistics show the disease causes 655,000 deaths worldwide per year.