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Related Experiment Videos

Monooctanoin-associated pulmonary edema.

L K Hine1, J B Arrowsmith, H E Gallo-Torres

  • 1Division of Epidemiology and Surveillance, Food and Drug Administration, Rockville, Maryland.

The American Journal of Gastroenterology
|October 1, 1988
PubMed
Summary

Monooctanoin effectively dissolves retained biliary stones. However, noncardiogenic pulmonary edema is a rare but serious adverse event, occurring in about 1 in 1000 patients receiving this treatment.

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Area of Science:

  • Gastroenterology
  • Pulmonology
  • Pharmacovigilance

Background:

  • Monooctanoin is a cholesterol solvent used for retained biliary stone dissolution.
  • Biliary stones can cause significant patient morbidity.
  • Intrabiliary administration requires careful safety monitoring.

Purpose of the Study:

  • To investigate the incidence and characteristics of noncardiogenic pulmonary edema associated with intrabiliary monooctanoin.
  • To assess the safety profile of monooctanoin in clinical practice.

Main Methods:

  • Systematic review of published literature.
  • Analysis of adverse drug reaction reports from the FDA Spontaneous Reporting System.
  • Case series analysis of noncardiogenic pulmonary edema events.

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Main Results:

  • Four cases of noncardiogenic pulmonary edema were identified.
  • Pulmonary edema occurred during intrabiliary monooctanoin infusion.
  • The estimated incidence of this adverse event is approximately 1 in 1000 patients.

Conclusions:

  • Intrabiliary monooctanoin, while effective for gallstone dissolution, carries a risk of noncardiogenic pulmonary edema.
  • Healthcare providers should be vigilant for this potential complication.
  • Further pharmacovigilance is warranted to fully characterize this risk.