FDA Issues New Warnings On Laxatives
By Cyndi Root
Laxatives are generally safe, said the Food and Drug Administration (FDA) in a new safety communication, but can turn dangerous under certain conditions. Misusing over-the-counter laxatives with sodium phosphate can cause damage to the heart and kidneys and may result in death. Previous warnings about sodium phosphate drug products communicated risks related to bowel cleansing and colonoscopies. Laxatives help with constipation, difficulty with bowel movements.
In a Consumer Update, Mona Khurana, M.D., of the FDA’s Division of Nonprescription Regulation Development said, “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.“
Decades of Reports
The FDA’s warning comes after a review of the FDA Adverse Event Reporting System (FAERS). Researchers looked at reports in the database from 1969 to 2012. They also searched related medical literature as far back as 1957. The agency looked for adverse events associated with oral or rectal laxatives with sodium phosphate.
Scientists found 54 adverse events, mostly in children and older adults. 12 adults and 1 child had a fatal outcome. Most of the 42 people with non-fatal outcomes faced life-threatening issues including heart problems, deterioration in mental status, and respiratory deficits. Others experienced damage to the kidneys and/or the heart or became dehydrated due to the changes in electrolytes.
The people who died and those who experienced severe problems fell into one of two categories but all failed to follow directions. They took more than one dose or the dose was too high. Additionally, certain populations had a higher risk. People over the age of 55 and children under the age of five had a higher risk rate. People with existing kidney disease and those who were already dehydrated also had more problems.
FDA Recommendations
The Consumer Update outlines the FDA’s recommendations. The agency recommends only one dose per day for no more than three days. It says never give laxatives to children under the age of two, and to seek medical approval when giving the drug to a child under the age of five. Older adults over the age of 55 should also seek medical advice before use. Others risk groups who should seek medical care are those with kidney, heart, and colon disease and people taking medications including anti-inflammatory drugs like ibuprofen.