|Can a laxative overdose be fatal?|
|FDA warning consumers to carefully follow instructions|
|Published Tuesday, January 14, 2014|
|The FDA is now warning adults over 55 and children with certain healthy conditions to consult with a healthcare professional prior to using these products because they may be at an increased risk for harmful side effects.|
Constipation may not be the most polite topic of conversation, but it’s a condition that bothers many of us, at least on occasion.
According to the Food and Drug Administration, some over-the-counter laxatives are potentially dangerous, even deadly, if dosing instructions are not properly followed or when there are preexisting health conditions.
The FDA is warning consumers after receiving dozens of reports of serious side effects, including 13 deaths, associated with the use of laxatives containing sodium phosphate.
According to Mona Khurana M.D., a medical officer in FDA’s division of Nonprescription Regulation Development and a pediatric nephrologist, the most serious harm in recent reports occurred after consumers overdosed by taking a single dose that was higher than recommended on the Drug Facts label or took more than one dose a day.
“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.
The FDA has identified 54 cases of serious side effects associated with OTC sodium phosphate products. Thirteen cases were fatal, including one child.
“It is not possible to determine the precise rate of these events as no one knows how many individuals who take these medications may experience side effects,” said Khurana, adding: “Not everybody who develops problems in association with sodium phosphate use reports to the FDA.”
Sodium phosphate laxatives, according to the label, should only be used as a single dose taken once a day and should not be used for more than three days.
In addition, the FDA is now warning adults over 55 and children with certain health conditions to consult with a healthcare professional prior to using these products because they may be at an increased risk for harmful side effects. These new warnings are not currently on the Drug Facts label.
Visit www.FDA.gov for more information.
Send this page to a friend