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On January 8, 2014, FDA is warning the public 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. 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.


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.


Some individuals may be at higher risk for potential adverse events when OTC sodium phosphate’s recommended dose is exceeded. These individuals include young children; individuals older than 55 years; patients who are dehydrated; patients with kidney disease, bowel obstruction or inflammation; and patients using medications that may affect kidney function such as diuretics, angiotensin-converting enzyme inhibitors, angiotensin receptor blockers, and nonsteroidal anti-inflammatory drugs.


FDA communicated previously in 2008 about the risk of kidney injury with the use of oral sodium phosphate drug products at higher doses for bowel cleansing prior to colonoscopy or other procedures.


Adverse events involving OTC sodium phosphate drugs should be reported to the FDA MedWatch program at www.fda.gov/medwatch.


Thank you for listening. A link to the full communication detailing the 2008 communications, specific information for healthcare professionals, and the complete Data Summary can be found at www.fda.gov/DrugSafetyCommunications. If you have drug questions, you can reach us at druginfo@fda.hhs.gov.


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Posted on the FDA website on 31 January 2014