Arrhythmia/EP
Digitek digoxin tablets recalled: Possible double dose released by accident
Apr 29, 2008 | Shelley Wood

Morristown, NJ - The manufacturer of Digitek digoxin tablets is recalling the product, saying that it may have accidentally released pills that are double the normal thickness, carrying twice the normal dose [1].

Digoxin is used in the treatment of arrhythmias and heart failure, and a double dose could cause toxicity, most notably in patients with renal failure. According to a press release from Digitek's manufacturer, Actavis, digitalis toxicity "can cause nausea, vomiting, dizziness, low blood pressure, cardiac instability, and bradycardia," and even death.

The FDA is alerting doctors and the public to the recall via its MedWatch program. The agency notes that several reports of illness and injury have been reported. Digitek is distributed by Mylan Pharmaceuticals under a Bertek label and by UDL Laboratories under a UDL label, the Actavis press release notes.

Source
  1. Actavis. Actavis Totowa (formerly known as Amide Pharmaceutical Inc) recalls all lots of Bertek and UDL Laboratories Digitek (digoxin tablets, USP) as a precaution [press release]. April 25, 2008. Available at: http://www.actavis.us/en/media+center/newsroom/articles/digitek+recall.htm.



You have to be logged in to add a comment to this article
Login
Username 
Password 
  Forgot your password?
 
Remember me on this computer
 
Register
Click on "register" to create a account - It is free....
 
button
Previews
Featured CME
Inside: Arrhythmia/EP
Arrhythmia/EP
May 27, 2008 11:30 EDT
Drs Lindsay, Brugada, Gold and Stein highlight the most recent clinical trial data demonstrating the efficacy and safety of ICDs and cardiac resynchronization therapy (CRT) devices and their potential impact on clinical practice.
Arrhythmia/EP
Sep 27, 2007 10:00 EDT
In this program, critical aspects of remote monitoring will be discussed using case studies and active audience participation. It will highlight and evaluate present and future strategies in the identification and treatment of patients with heart failure, with special emphasis on the development of a clinical consensus that will help guide physicians to successfully meet the challenges of heart failure patient management. With Drs Silver, Ewald, Horstmanshof, Semigran and Mary Orencole MS, APRN.
Arrhythmia/EP
Jun 3, 2008 10:56 EDT
In the ATHENA trial, an investigational amiodarone congener prolonged time to first CV hospitalization or death in elderly AF patients. The electrophysiologists have had their say what are the implications for the rest of the cardiology community? Hear Drs Alpert, Steg and Topol give the non-EP perspective.
Arrhythmia/EP
May 19, 2008 12:20 EDT
The ATHENA trial was a late-breaker at Heart Rhythm 2008. Join Drs Prystowsky, Hohnloser, Ruskin and Waldo as they discuss pharmacologic challenges in AF management.