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Sodium Phosphate Over-the-Counter Products: Drug Safety Communication - Possible Harm From Exceeding Recommended Dose

January 8, 2014

Audience: Consumer, Family Practice

Marketed under the brand-name Fleet, and as store brands and generic products.

 

[Posted 01/08/2014]

ISSUE: 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. 

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.

For additional clinical information, see the FDA Drug Safety Communication Data Summary.  

BACKGROUND: OTC sodium phosphate drug products include oral solutions taken by mouth and enemas used rectally. Marketed under the brand-name Fleet, and as store brands and generic products. Available as single-ingredient drug products, containing either sodium biphosphate or sodium phosphate, and as combination drug products containing both ingredients.

RECOMMENDATION: Consumers and health care professionals should always 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.  Caregivers should not give the oral products to children 5 years and younger without first discussing with a health care professional.  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.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

  • Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
  • Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

[01/08/2014 - Drug Safety Communication - FDA]

[01/08/2014 - Consumer Update - FDA]

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