On April 25, 2008, a nationwide Digitek Tablet Recall was issued for the heart medication. Manufacturing problems caused some tablets to contain twice as much of the active ingredient as normal. This could result in digitalis toxicity in patients with impaired kidney function, which is a serious and potentially fatal illness.
Individual lawsuits and Digitek class actions are currently pending. All of the federal Digitek litigation has been consolidated in an MDL in the Southern District of West Virginia.
Digitek which contains the active ingredient Digoxin, is a cardiac medication used to treat heart failure, heart arrthymia such as atrial fibrillation and atrial flutter. The recall was initiated by Actavis after the manufacturer received several reports of severe illnesses and serious injuries which were consistent with over medication.
As a result of the defectively manufactured Digitek tablets, users with decreased kidney function, including those with renal failure may have digitalis accumulate in the body when it is not excreted as normal through urine. This could lead to a serious and potentially fatal illness known as “digitalis toxicity”.
The Digitek recall has been labeled a Class 1 nationwide recall, since use of the digonex tablets carries a substantial risk of serious or fatal injury.
Medical Analysis: Digoxin is an important cardiac drug but it has a narrow therapeutic window. In other words the amount needed to treat a patient is slightly less than the amount that causes toxicity. Toxicity is increased in the elderly and those with kidney dysfunction.