Generic Digoxin Recall Issued Due to Oversized Tablets

Caraco Pharmaceutical Laboratories has issued a generic digoxin recall after discovering that some pills may have been distributed that contain more or less of the active drug than they should. A similar recall was issued last year due to oversized Digitek, a different brand of the generic heart drug digoxin, which has been linked to 667 deaths.

Digoxin is a medication used to treat abnormal heart rhythms, atrial flutter, atrial fibrillation and heart failure. It is derived from digitalis contained in foxglove plants and has been used for cardiac treatment since the 18th century. It is currently sold by a number of different generic drug makers.

Caraco issued the Digoxin recall for all lots of the drug they produced, including 0.125 mg tablets (which are round yellow tablets with an imprint of “437”) and 0.25 mg tablets (which are round white tablets with an imprint of “441”). The tablets were sold in 100-count and 1000-count bottles.

According to a press release issued on March 31, 2009, the recall was issued because some of the tablets may differ in size and therefore could provide too much or too little of the medication.

Digoxin is a very dose-specific drug with a narrow therapeutic index and receiving more or less of the drug could pose a serious risk of injury.

Receiving less Digoxin than the doctor prescribed could cause the medication to be ineffective, potentially resulting in cardiac instability.

If too much of the drug is taken, it could cause digoxin toxicity, particularly among those suffering from renal failure. An overdose of digoxin could cause high levels of digitalis to build up inside the body, potentially resulting in life-threatening conditions, with symptoms like nausea, vomiting, low blood pressure, dizziness, bradycardia and cardiac instability.

In April 2008, Actavis Totowa issued a similar digoxin recall for their brand of the generic heart drug, Digitek, after it was discovered that oversized tablets were commercially released. According to a report issued by the Center for Public Integrity in December 2008, at least 667 digoxin deaths were reported to the FDA between April 2007 and June 2007 involving potentially double strength Digitek tablets.

Actavis Totowa and several of their distributors currently face a growing number of Digitek lawsuits filed on behalf of individuals who have suffered severe or fatal injuries caused by digoxin toxicity. All of the federal cases are consolidated in an MDL in the U.S. District Court for the Southern District of West Virginia before U.S. District Judge Joseph Goodwin, who is also coordinating the management of the litigation with various state court judges throughout the United States.