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Related Experiment Videos

Propafenone associated agranulocytosis.

L J Miwa1, H M Jolson

  • 1Epidemiology Branch, Food and Drug Administration, Rockville, Maryland 20857.

Pacing and Clinical Electrophysiology : PACE
|April 1, 1992
PubMed
Summary

Propafenone hydrochloride, approved in 1989, has been linked to agranulocytosis, a serious blood disorder. The U.S. Food and Drug Administration (FDA) identified four cases, suggesting underreporting of this adverse event.

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Area of Science:

  • Pharmacology
  • Hematology

Background:

  • Propafenone hydrochloride, an antiarrhythmic medication, received U.S. Food and Drug Administration (FDA) marketing approval in November 1989.
  • Clinical trials and post-marketing surveillance are crucial for identifying drug-related adverse events.

Observation:

  • Agranulocytosis, a severe reduction in white blood cells, was observed during U.S. clinical trials of propafenone.
  • Seven additional cases of agranulocytosis and one of granulocytopenia were reported internationally.
  • The FDA reviewed adverse events in January 1991, identifying four reports of agranulocytosis associated with propafenone.

Findings:

  • The identified cases suggest a potential risk of agranulocytosis with propafenone use.
  • The estimated reporting rate of one case per 10,000 prescriptions may underestimate the true incidence of this adverse event.

Implications:

  • Healthcare providers should be vigilant for signs of agranulocytosis in patients prescribed propafenone.
  • Further pharmacovigilance is warranted to accurately assess the risk of propafenone-induced agranulocytosis.
  • This information is critical for patient safety and informed prescribing decisions regarding propafenone hydrochloride.

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