Pansy Mae Christian, who suffered from a cardiac condition, died on November 8, 2007 after taking Digitek prescribed by her doctor. On May 2008, Christian’s estate administrator James R. Christian received notice of the drug’s recall and complaints about significant adverse side effects.

On January 15, 2008, Gary Lucineo suffered toxicity and died after taking Digitek prescribed by his physician for congestive heart failure. His estate administrator, Jeanette Lucineo, is suing the companies, claiming they failed to warn users of the drug that the medication was provided for use by the public with twice the approved level of active ingredient. That overdose caused toxicity that the suit claims contributed to Mr. Lucineo’s death.

In April 2005, Actavis Totowa LLC, initiated a nationwide Class I recall of Digitek after it learned that oversized tablets had been distributed, which likely contained twice the level of active ingredient. Taking more than the FDA-approved level of Digitek can lead to Digitek toxicity, also known as digitalis toxicity, a serious and life-threatening complication. Symptoms of digitalis toxicity include unusual visual changes, confusion, loss of appetite, nausea, vomiting or diarrhea, palpitations or irregular pulse.

If you are taking digitalis medications and symptoms of digitalis toxicity develop, contact your healthcare provider immediately.

SOURCE: Digitek Recall › Two lawsuits filed against makers of Digitek heart medication

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.

SOURCE: Digitek Recall › Actavis signs consent decree to resume making Digitek

According to the West Virginia Record, Goodwin wrote, “Some complaints in this MDL action join multiple plaintiffs whose only apparent connection with one another is that they ingested the drug at issue.”

Goodwin gave all plaintiff lawyers a Dec. 31 deadline “to identify all multi-plaintiff actions subject to his order and propose a severance order.”

After the 30 days of separation, the plaintiff must file a revised complaint. Goodwin wrote, “The severed and amended complaint must contain the specific claims asserted by the plaintiffs named in it.”

In cases of husbands and wives as plaintiffs, Goodwin won’t sever the cases.

For deaths and illnesses associated with Digitek, plaintiffs seek compensation from the Digitek drug companies Mylan Pharmaceuticals of West Virginia and Actavis Group.

SOURCE: Digitek Recall › Goodwin to seperate federal digitek complaints

Dingell and Stupak’s letter questions not only the FDA’s inspection of the company’s facilities, but if the FDA should have allowed this company to resume its operation, even though it has a history of recalls.

According to PharmTech, Congress wants the FDA to provide documents “on all FDA-regulated products that Acatavis received approval to sell in the United States since January 1, 2003.”

At the end of July, Actavis Totowa decided to voluntarily recall “the retail level of all drug products manufactured at its Little Falls, New Jersey, facility.” This recall took place after the FDA conducted an inspection of the company in April when Digitek was recalled because the pills were double in “the appropriate thickness.” In this third recall, the recalled pills are believed to have contained twice the correct amount of medication.

Digitek is not the only product that Actavis has recalled; in March, Actavis South Atlantic LLC recalled U.S-sold fentanyl transdermal system CII patches. They may have “a fold-over defect,” which may leak fentanyl gel.

The Actavis Group is not only the producer of Digitek but also many other products. According to Actavis’ website, Actavis is “one of the world’s leading players in first-class generic pharmaceuticals.” We will see just how much longer this statement remains to be true.

SOURCE: Digitek Recall › Congress investigates FDA inspection of Actavis