FDA Warning of Over-the-counter Sodium Phosphate

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FDA Drug Safety Communication:

FDA is warning that using more than one dose in 24 hours of over-the-counter (OTC) sodium phosphate drugs to treat constipation can cause rare but serious harm to the kidneys and heart, and even death.  

Some individuals may be at higher risk for potential adverse events when the recommended dose of OTC sodium phosphate is exceeded. These individuals include young children; individuals older than 55 years; patients who are dehydrated; patients with kidney disease, bowel obstruction, or inflammation of the bowel; and patients who are using medications that may affect kidney function. Health care professionals should use caution when recommending an oral dose of these products for children 5 years and younger.  The rectal form of these products should never be given to children younger than 2 years.

Severe dehydration and electrolyte abnormalities associated with serious complications such as acute kidney injury, arrhythmias, and death have occurred in adults and children who overdosed using oral or rectal over-the-counter (OTC) sodium phosphate solutions to treat constipation. The severity of adverse events is similar regardless of the route of sodium phosphate administration. Rectal forms of sodium phosphate drug products should not be considered safer than the oral forms.

For more information please see the FDA Drug Safety Communication at: www.fda.gov/Drugs/DrugSafety/ucm380757.htm