Actavis Inc. has signed a proposed consent decree agreeing to fix the manufacturing problems at its New Jersey plant where it produced and sold the heart drug, Digitek, a brand of digoxin, according to the Canadian Medical Association Journal.
Digitek was cited by the Center for Public Integrity as the “primary suspect” in 667 deaths reported between April 1, 2008 and June 30, 2008. Digitek is prescribed for various heart conditions such as atrial fibrillation, atrial flutter and sometimes heart failure. An incorrect dosage or overdosage can be dangerous and even fatal to heart patients taking the medication, causing even more cardiac instability and compounding existing problems.
Last April, it was discovered that some tablets produced in the Actavis New Jersey plant were oversized and contained as much as twice than the marked dosage of the active ingredient. A massive recall was ordered and Actavis contends that none of the oversized pills reached consumers. The New Jersey plant was officially closed in August to correct its shoddy manufacturing practices, and in November the U.S. Justice Department ordered the plan remain closed until it could prove it has met the FDA’s “Good Manufacturing Practice.”
In January, the FDA announced that it would allow Actavis to resume its production of Digitek provided it proves it has cleaned up its act. Actavis signed the proposed consent decree but whether it will start making Digitek again is anyone’s guess.
A division of the Icelandic Actavis Group, Actavis is among of the world’s five largest drug makers.