Food and Drug Administration headquarters building in Silver Spring, Md. The FDA has issued a new warning about certain laxatives.(Photo: Alison Young, USA TODAY)
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.
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
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 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.
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
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."