Overdoses of Fleet and other sodium phosphate-based laxatives can cause severe kidney damage, heart injury and even death, according to a new FDA warning.
On January 8, the FDA issued a drug safety communication warning against the use of more than one dose or application of sodium phosphate-based laxatives, advising that too much can lead to severe and sometimes fatal side effects.
The FDA indicates that taking more than one dose in 24 hours or taking more than the recommended amount of the laxatives, in either oral or enema form, can cause severe dehydration, and changes in the levels of serum electrolytes. These laxative side effects can cause damage to organs, including the heart and kidneys, potentially increasing the risk of death in some cases.
The warning comes after an FDA review of decades of adverse event reports and medical literature dating as far back as 1957. From that data, the FDA found dozens of cases of adults and children suffering severe health problems after overdosing Fleet and other over-the-counter sodium phosphate laxative products used to treat constipation. Most cases involved children younger than five years old and older adults.
The FDA indicates that nearly half of the adult reports and two-thirds of the children involved dehydration, kidney disease, acute colitis, or delayed bowel emptying. There was also often concomitant use of drugs that affect the kidneys, such as diuretics and non-steroidal anti-inflammatory drugs (NSAIDs) like Motrin and Alleve.
“All reports of serious outcomes were characterized by dehydration and/or electrolyte disturbances with associated complications such as acute kidney injury and death,” the FDA warning reports. “Nearly half of adult cases and 3% of pediatric cases reported a fatal outcome.”
The FDA advises consumers to always read the Drug Facts labels and use the products as recommended, never exceeding the recommended dose. Consumers taking NSAIDs, diuretics, angiotensin-converting enzyme inhibitors, angiotensin receptor blockers for high blood pressure, or those suffering from an inflamed colon should consult a physician before using one of these over-the-counter laxative products.
The agency also warns that caregivers should never give the product to children 5 years and younger without first discussing it with a health care professional. The rectal form of the drugs should never be given to children younger than two years of age, the agency warns.
Fleet Phospho-Soda Recall and Litigation
This is not the first time the FDA has warned about the risk of problems with Fleet and similar laxatives.
In 2008, a Fleet Phospho-soda recall was issued after the FDA indicated that the over-the-counter oral sodium phosphate solution should not be used as a bowel cleanser due to the risk of acute phosphate nephropathy, a rare form of kidney damage.
After the recall, more than 1,200 Fleet Phospho-soda kidney lawsuits were filed in various state and federal courts throughout the United States. Most were resolved in a global settlement in 2010.