On January 8, 2014, the FDA warned 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.
The 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.
The FDA communicated previously in 2006 and 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. The FDA had become aware of reports of acute phosphate nephropathy, a type of acute kidney injury, associated with the use of oral sodium phosphate products (OSP) for bowel cleansing prior to colonoscopy or other procedures.
Acute phosphate nephropathy is a form of acute kidney injury that is associated with deposits of calcium-phosphate crystals in the renal tubules that may result in permanent renal function impairment. The offending products include the prescription products, Visicol and OsmoPrep, and OSPs available over-the-counter without a prescription as laxatives (e.g., Fleet Phospho-soda). In some cases when used for bowel cleansing, these serious adverse events have occurred in patients without identifiable factors that would put them at risk for developing acute kidney injury. The FDA cannot rule out, however, that some of these patients were dehydrated prior to ingestion of OSPs or they did not drink sufficient fluids after ingesting OSP.
See the Recall
See also Medical Law Perspectives, May 2013 Report: Drugs, Dosage, and Damage: Physician Liability for Prescribing or Administering Medication