There have been dozens of reports of serious side effects, including 13 deaths, associated with the use of sodium phosphate laxatives.
The label of sodium phosphate laxatives states they should be used as a single dose taken once a day, and the products should not be used for more than three days. Equally important, consumers who do not have a bowel movement after taking an oral or rectal dose should not take another dose of the product.
In addition, labeling instructs adults and children to consult healthcare professionals before using these products if they have kidney disease, heart problems or dehydration.
Dr. Mona Khurana, a medical officer in the FDA's Division of Non-prescription Regulation Development, said the most serious harm in recent reports occurred after consumers overdosed by taking a single dose that was higher than recommended on the drug label or took more than one dose in a day because they had a poor laxative effect from the first dose.
"The bottom line is that these products are safe for otherwise healthy adults and older children for whom dosing instructions are provided on the drug facts label as long as they follow these dosing instructions and don't take the product more often, or in greater amounts, than the label instructs," Khurana said in a statement.
Laxative products containing sodium phosphates are marketed under the brand name "Fleet" and also as store brands and generic products. All are potentially associated with serious side effects, such as dehydration and/or abnormal levels of electrolytes in the blood that can lead to serious complications, such as kidney damage and sometimes death, the FDA said.