FDA Warns Against Exceeding Recommended Doses of Over-the-Counter Sodium Phosphate Products for Constipation

In a warning issued last week, the United States Food and Drug Administration (FDA) suggested that the use of over-the-counter (OTC) sodium phosphate drugs for the treatment of constipation should not exceed the allotted dose per 24 hours. According to the FDA, rare but serious damage to the heart and kidneys can occur in persons who exceed the recommended dosage of these drugs; in some cases, excess amounts of the OTC medication could result in death.

The OTC sodium phosphate drugs used to alleviate constipation come in the form of:

  • Oral solutions to be taken by mouth
  • Enemas to be used rectally

The FDA’s warning comes after a series of reports, each of which detail the complications that can stem from taking the drug. Severe dehydration and adverse changes in serum electrolyte levels can occur from taking more than the recommended dose of the medicine. The serum electrolytes that can be affected include calcium, phosphate, and sodium.

In particular, the FDA is warning against taking a single dose of sodium phosphate that is larger than the recommended amount and taking more than one dose of sodium phosphate per day. Reports have indicated that most of the serious incidents that have occurred in connection with the OTC drug have been under these circumstances.

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Individuals who are at higher risk of experiencing adverse side effects when taking more than the recommended dose of a sodium phosphate drug include:

  • Young children
  • Adults over the age of 55
  • Individuals who are dehydrated
  • Patients with kidney disease
  • Patients taking medications known to affect kidney function
  • Patients with bowel obstruction or inflammation of the bowel

This is not the first communication heard from the FDA regarding the risk of kidney injury from the use of certain oral sodium phosphate drug products. Similar warnings about the risk of using excess amounts of these drugs were issued in 2008. Nevertheless, the products have remained on the market for use by unsuspecting consumers.

If you or someone you love experienced serious and adverse side effects from the use of a sodium phosphate drug that was taken in excess of the dosage level, a defective drug attorney at our office may be able to help. Calling us to discuss your case will cost you nothing, so don’t wait. We can be reached at 888-773-0849.