Search research articles

Search research articles

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

Summary

This summary is machine-generated.

Related Concept Videos

You might also read

Related Articles

Articles linked to this work by shared authors, journal, and citation graph.

Sort by

Same author

Discriminators between hantavirus-infected and -uninfected persons enrolled in a trial of intravenous ribavirin for presumptive hantavirus pulmonary syndrome.

Clinical infectious diseases : an official publication of the Infectious Diseases Society of America·2002

Same author

Intravenous ribavirin for hantavirus pulmonary syndrome: safety and tolerance during 1 year of open-label experience. Ribavirin Study Group.

Antiviral therapy·2000

Same author

Value of epidemiologic studies in determining the true incidence of adverse events. The nonsteroidal anti-inflammatory drug story.

Archives of internal medicine·1997

Same author

The incidence of depression in new users of beta-blockers and selected antihypertensives.

Journal of clinical epidemiology·1996

Same author

Alternatives to intravenous tetracycline hydrochloride for malignant pleural effusions.

The Annals of pharmacotherapy·1994

Same author

Capability of hospital computer systems in performing drug-use evaluations and adverse drug event monitoring.

American journal of hospital pharmacy·1993

ABOUT JoVE

Overview Leadership Blog JoVE Help Center

AUTHORS

Publishing Process Editorial Board Scope & Policies Peer Review FAQ Submit

LIBRARIANS

Testimonials Subscriptions Access Resources Library Advisory Board FAQ

RESEARCH

JoVE Journal Methods Collections JoVE Encyclopedia of Experiments Archive

EDUCATION

JoVE Core JoVE Business JoVE Science Education JoVE Lab Manual Faculty Resource Center Faculty Site

Terms & Conditions of Use

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.

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.

Related Experiment Videos

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.