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FDA Warns of Risks from Overdose of OTC Sodium Phosphate for Constipation — Physician’s First Watch

Medical News |
January 9, 2014

FDA Warns of Risks from Overdose of OTC Sodium Phosphate for Constipation

By Kelly Young

The FDA is warning that the over-the-counter constipation drug sodium phosphate (marketed as Fleet, and generics) has been tied to heart and kidney damage and even death when patients exceed the recommended dose.

The agency has identified over 50 serious adverse events related to dehydration and electrolyte disturbances (sodium, calcium, and phosphate) with both the oral and rectal formulations. Most cases occurred in older adults and children younger than 5 years.

The FDA warns:

  • Rectal sodium phosphate should never be used in children under age 2 years.

  • In children 5 years and younger, caution should be used in recommending the oral version.

  • Patients should stay below the maximum recommended dose; they should not take another dose within 24 hours.

  • Patients at higher risk include those older than 55; those with decreased intravascular volume, baseline kidney disease, decreased bowel transit time, or active colitis; and those taking diuretics, ACE inhibitors, angiotensin receptor blockers, or NSAIDs.

  • Patients should be advised to stay well hydrated during use. Electrolytes and renal function should be assessed in high-risk patients.

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