FDA Warning of Serious Risks of Over-the-Counter Sodium Phosphate Constipation Medicines

Over-the-counter (OTC) sodium phosphate enema drugs to treat constipation can cause rare but serious harm to the kidneys and heart, and even cause death, the Food and Drug Administration (FDA) warned in a safety communication on January 8.

Taking more than one dose in 24 hours or exceeding the recommended dose can result in severe dehydration and changes in the levels of serum electrolytes, which can result in serious adverse effects on organs including the kidneys and heart, in some cases resulting in death. In issuing the warning, the FDA referred to reports of such serious adverse effects and deaths from taking more than the recommended dose of OTC sodium phosphate products.

OTC sodium phosphate products for the treatment of constipation are available as solutions taken by mouth and enemas used rectally. These products are sold under the brand name Fleet and in store brand and generic formulas. Some OTC enema medications contain a single active ingredient—sodium biphosphate or sodium phosphate—others are combination products containing both ingredients.

In the safety alert, the FDA advises consumers to carefully read the Drug Facts on any OTC sodium phosphate drug and use the product as recommended, never exceeding the labeled dose. Caregivers should never give these products to children under five without first consulting a health care professional and health care professionals should be cautious in recommending oral sodium phosphate drugs for children five and younger. Rectal forms of these products should never be given to children younger than two.

Adverse events or side effects related to the use of these products may be reported through the FDA’s MedWatch Safety Information and Adverse Event Reporting Program: www.fda.gov/MedWatch/report.htm.