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

American Journal of Cardiovascular Drugs : Drugs, Devices, and Other Interventions
Sean Patrick NordtRichard F Clark

Abstract

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. 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. 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. 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). During the period of manufacturing error, there was a statistically...Continue Reading

References

Feb 20, 1997·The New England Journal of Medicine·UNKNOWN Digitalis Investigation Group
Apr 29, 1998·JAMA : the Journal of the American Medical Association·J LazarouP N Corey
Oct 4, 2006·Clinical Toxicology : the Official Journal of the American Academy of Clinical Toxicology and European Association of Poisons Centres and Clinical Toxicologists·Melisa W LaiKathleen M Wruk
Dec 23, 2008·The American Journal of Cardiology·UNKNOWN Digitalis Investigation GroupShahbudin H Rahimtoola

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Citations

May 14, 2014·Journal of Controlled Release : Official Journal of the Controlled Release Society·Nupura S BhiseAli Khademhosseini
Aug 16, 2011·The Consultant Pharmacist : the Journal of the American Society of Consultant Pharmacists·David R P Guay

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