Digitek® (digoxin tablets), a drug manufactured by Actavis Totowa LLC and used to treat heart failure and abnormal heart rhythms has been linked to Digitalis toxicity. Digitalis toxicity can cause nausea, vomiting, dizziness, low blood pressure, cardiac instability and bradycardia. Death can also result from excessive Digitalis intake.
What’s the Problem?
Actavis Totowa LLC, a United States manufacturing division of the international generic pharmaceutical company Actavis Group, is initiating a Class I nationwide recall of Digitek® (digoxin tablets, USP, all strengths) for oral use. The products are distributed by Mylan Pharmaceuticals Inc., under a "Bertek" label and by UDL Laboratories, Inc. under a "UDL" label.
According to reports, patients taking Digitek or Digoxin are receiving phone calls from their pharmacist and/or letters from their pharmacy advising them of the recall.
The voluntary all lot recall is due to the possibility that tablets with double the appropriate thickness may have been commercially released. These tablets may contain twice the approved level of active ingredient than it appropriate.
Digitek® is used to treat heart failure and abnormal heart rhythms. The existence of double strength tablets poses a risk of digitalis toxicity in patients with renal failure. Digitalis toxicity can cause nausea, vomiting, dizziness, low blood pressure, cardiac instability and bradycardia. Death can also result from excessive Digitalis intake.
Several reports of illnesses and injuries have been reported to the Food & Drug Administration (FDA).
Digitek Settlement Reached to Resolve Lawsuits Over Heart Drug
In September 2010, a settlement was reached that resolved all outstanding state and federal Digitek lawsuits.
Attorneys for plaintiffs and defendants informed U.S. District Judge Joseph Goodwin that they had reached an agreement to settle Digitek lawsuits filed by hundreds of people who claim they were injured by a Digitek overdose.
The complaints were prompted by a 2008 Digitek recall that was issued after Actavis Towtowa allegedly distributed pills that contained too much of the drug.
As a result, hundreds of Digitek lawsuits were filed in state courts and federal district courts across the U.S. The federal Digitek litigation was consolidated in the U.S. District Court for the Southern District of West Virginia as part of a multidistrict litigation (MDL).
Related Article: Digitalis Toxicity Linked to Digitek (Digoxin)