David H. Balaban, MD, FACG
David H. Balaban, MD, FACG

Poster 543 Adverse Events Associated With Sodium Phosphate (Saline) Enema in Adults: A 46-Year Database and Clinical Survey

Author Insight from David H. Balaban, MD, FACG, Charlottesville Gastroenterology Associates

What’s new here and important for clinicians?

In January 2014, the FDA issued a safety communication warning that use of more than the labeled dose of one sodium phosphate enema in a 24-hour period could cause rare but serious cardiac and renal effects.  Information from case reports suggests that serious adverse events related to enema are reported with overdose, and U.S. clinicians may be unaware of the labeled dosing recommendation.  We analyzed a safety database of saline enema use in adults maintained by a manufacturer of saline enema (Fleet Laboratories), FDA MedWatch reports and the medical literature.  We found that while adverse events are very rare, overdose of saline enema was significantly associated with both serious adverse events and fatality when compared to non-serious adverse events.  In 16 cases of serious adverse events in which overdose was documented, a healthcare provider prescribed the improper dose in 15 of those cases.  Fleet conducted a companion survey of U.S. gastroenterologists after the FDA communication to better understand if there remained unresolved educational needs of gastroenterologists regarding the proper use of sodium phosphate enema. The majority of clinicians included in the survey were inattentive to the appropriate enema dosing guidelines.   As stated in the FDA safety communication, clinicians should follow the drug fact labeling and limit enema use to one saline enema in a 24-hour period.

What do patients need to know?

Patients should follow the directions on the enema label and only use one saline enema in a 24-hour period.  If additional enemas are required, a water-based enema would be appropriate.

Read the abstract

Chart Overdose is Associated with Serious and Fatal Adverse Events

Author Contact David H. Balaban, MD, FACG, Charlottesville Gastroenterology Associates



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