Products containing sodium phosphate, sold as Fleet, store brands and generics, are linked to 13 deaths.
Certain over-the-counter laxatives used to treat constipation can be dangerous when taken too often, in the wrong dose or by people with various health conditions, the Food and Drug Administration is warning.
The FDA issued the new warning Wednesday after reviewing decades of reports and finding 54 illnesses and 13 deaths in people who used oral laxatives or enemas containing sodium phosphate. The products are marketed under the brand name Fleet, as store brands and as generics, FDA says.
Misuse of the products can lead to dehydration or dangerous changes in electrolytes, which can damage kidneys and hearts.
Most of the trouble occurs when people fail to follow label directions and take more than one dose in a day or use a dose that is too high, FDA says.
At especially high risk: people over age 55 and children and adults who already are dehydrated or have kidney disease, heart problems or inflamed colons. Risks also are elevated in people taking many common medications that affect kidney function, including diuretics and other blood pressure drugs and non-steroidal anti-inflammatory drugs, such as ibuprofen. Those drug interaction warnings are not currently on labels, FDA says.
The agency also says caregivers should check with a doctor before giving the oral laxatives to children under age 5 and should never give the rectal products to children under age 2. The agency says one of the 13 deaths occurred in a child.
The agency reviewed reports filed with FDA as far back as 1969 and reported in medical journals as far back as 1957, says Andrea Fischer, an FDA spokesperson.
In an online consumer update, FDA official Mona Khurana says it's not possible to say how many people have been harmed by the products, since not all cases are reported to FDA. But she also says that "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."