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Am J Cardiovasc Drugs. 2010;10(4):261-3. doi: 10.2165/11537640-000000000-00000.

Retrospective review of digoxin exposures to a poison control system following recall of Digitek® tablets.

Author information

1
Department of Emergency Medicine, University of Southern California, Los Angeles, California, USA. spnordt@hotmail.com

Abstract

BACKGROUND:

In April 2008, Digitek® digoxin tablets were recalled by the manufacturer as possibly containing double the labeled amount of drug. The recall to March 2006 involved 800 million tablets.

OBJECTIVE:

The aim of this study was to evaluate whether there was any increase in the number of calls to a poison control system, and any increase in the severity of exposures after the recall compared with before the recall.

METHODS:

A retrospective review of all digoxin exposures to a poison control system from March 2004 to February 2008 was conducted, with data extracted from an electronic database (California Poison Control System). Total numbers of exposures were identified. Cases with moderate, major, and death outcomes were also identified and tallied. Chi-squared analysis was performed.

RESULTS:

Prior to the recall, there were 679 digoxin exposures. 148 (22%) were listed with moderate, major, or death as outcome. After the recall, there were a total of 610 cases, 165 (27%) with moderate, severe, or death as outcome. There was a statistically significant increase in the total number of moderate, major, and death outcomes after the period of the manufacturing error compared with before (p = 0.028).

CONCLUSION:

During the period of manufacturing error, there was a statistically significant increase in digoxin exposures with moderate, major, or death outcomes. The recall of Digitek® tablets may have increased moderate, major, or death outcomes from digoxin exposures in a poison control system database.

[Indexed for MEDLINE]

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