FDA Warns of Possible Harm from OTC Constipation Meds

January 09, 2014

The U.S. 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.

OTC sodium phosphate drug products include oral solutions taken by mouth and enemas used rectally. FDA has become aware of reports of severe dehydration and changes in the levels of serum electrolytes from taking more than the recommended dose of OTC sodium phosphate products, resulting in serious adverse effects on organs, such as the kidneys and heart, and in some cases resulting in death. These serum electrolytes include calcium, sodium and phosphate. According to the reports, most cases of serious harm occurred with a single dose of sodium phosphate that was larger than recommended or with more than one dose in a day.

Encourage your patients to read the drug facts label for OTC sodium phosphate drugs and use these products as recommended on the label, and not exceed the labeled dose. 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. 

More information is available in the FDA Consumer Update.

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