Digitek Problems Linked to 667 Deaths

Following Actavis Totowa’s Digitek recall in April 2008, the FDA received a spike in adverse event reports involving the generic digoxin heart drug and it has been identified as the “primary suspect” in at least 667 deaths reported to the agency from April 1 through June 30, 2008.

Digitek (digoxin), which was manufactured by Actavis Totowa, is used to treat heart failure and irregular heart rhythms. A recall for all lots of the drug was issued on April 25, 2008, after it was discovered that some tablets may be twice as thick as they are supposed to be, containing up to double the appropriate amount of the active pharmaceutical ingredient.

Oversized Digitek tablets could increase the risk of a digoxin overdose, know as digitalis toxicity, which can cause serious and potentially fatal injuries, including arrhythmias, heart failure and death

The Center for Public Justice, which is a nonprofit organization that produces original investigative journalism on issues of public concern, released a report on December 22, 2008, which questions whether the FDA and drug maker missed critical signals of Digitek problems and whether additional steps should have been taken to protect the public.

An analysis of FDA records indicates that there was a spike in reports Digitek problems during the months around the recall.

The Center’s report criticizes the FDA for taking too long to act on manufacturing problems at the New Jersey plant where Digitek was made, as FDA inspections up to two years prior to the recall uncovered signs of poor manufacturing practices and quality control problems. In addition, a number of public health experts indicate that the spike in reports of Digitek problems should have caused the FDA to more aggressively warn doctors, pharmacists and consumers about the risk of potentially defective tablets.

Despite the spike in Digitek problem reports, Actavis has maintained that none of their double strength pills ever reached the public, and that the recall was only issued as a precaution.

The company faces potentially hundreds of Digitek lawsuits filed on behalf of users who allege that serious and fatal digoxin overdose injuries were caused by oversized tablets they received. As of early November, at least 66 lawsuits over Digitek problems filed in federal courts have been centralized in an MDL in the U.S. District Court for the Southern District of West Virginia, and additional lawsuits have been in various state courts throughout the United States.