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Digitek Maker Recalling Generics While Digitek Cases Climb

Posted by Jane Akre
Monday, August 04, 2008 4:26 PM EST
Category: Major Medical, Protecting Your Family
Tags: Digitek, Heart Attack, FDA and Prescription Drugs, Federal Pre-emption, Dangerous Drugs,

Digitek lawsuits follow drug recall.



IMAGE SOURCE: Wikimedia Commons/ human heart/ author: Gray’s Anatomy


The manufacturer of the recalled drug Digitek, has announced it’s recalling all generic drugs made at its plant in Little Falls, New Jersey. 

Actavis Totowa is asking pharmacies, doctors, hospitals and retailers to return all affected medications after an FDA inspection revealed the plant didn’t meet acceptable manufacturing standards. 

The recall affects just the retail level, although medications can be replaced if a consumer chooses.  

The move follows an FDA inspection last year that found lapses in manufacturing at the New Jersey facility. The FDA list of recalled drugs can be found on its Web site. 

A lawsuit filed in United States District Court in Denver, Colorado Friday, charges pharmaceutical company Actavis Totowa LLC with manufacturing and distributing defective Digitek (generic name diogoxin). 

The federal suit, brought by a Denver, Colorado woman, says the heart drug pills caused the death of her husband because of the excessive dose of the drug’s active ingredient, digoxin.    

A nationwide recall of Digitek was announced by the FDA on April 25, 2008, after an inspection of the company’s New Jersey facility, in July 2006 through August 2006, revealed that drug products were adulterated.

Inspectors found some Digitek tablets were double the thickness and delivered twice the approved amount of the active ingredient.  A double dose can cause toxicity and renal failure

Digitek is used to treat congestive heart failure, atrial fibrillation and atrial flutter (irregular heartbeat).  Digitek is one of the cardiac (or digitalis) glycosides that have a specific effect on the myocardium and is extracted from the leaves of Digitalis lanata.  

Ohio attorney Richard Schulte, tells IB News he has at least 80 potential cases on his desk against Digitek. “Many of these cases will show digitalis toxicity,” he says. 

Schulte says the Digitek cases should hold up in court. "Since it's a manufacturing defect" he says drug makers will not be able to claim federal pre-emption, used by drug companies to argue they should enjoy blanket immunity from litigation since their drugs and labels were approved by the FDA.  

In the Denver case, the man's death occured August 2007, one year after the plant inspections. The action charges Actavis for failing to heed FDA warnings and says the drug maker should have known that production defects were dangerous, misbranded, and adulterated putting thousands of patients at an unnecessary risk of injury and death.  

“What makes this so tragic is that Actavis chose not to take appropriate measures in response to the FDA warnings in 2006 and 2007.  Scores of people have unnecessarily lost their lives,” said Beth Klein, pharmaceutical litigation attorney with the law firm Klein | Frank, P.C. in Denver, Colorado.

Another lawsuit filed by a Florida couple in Alabama says that Bobbie Dyal was prescribed Digitek and immediately experienced side effects. She was hospitalized and had a pacemaker implanted.

A class action lawsuit was filed in New Jersey in June.

The FDA notes that several reports of illness and injury have been reported.   The Class I recall by the FDA indicates the tablet could cause serious health problems or death. 

Los Angeles attorney Roger Drake, who has some Digitek cases, says that patients have been asked by the FDA to return unused drugs to the pharmacist, but proving a double dosage will be central to any litigation, he says. Drake is advising that patients hang onto the drug so it can be determined whether they contain the excessive medication.  

Side effects reported from the drug, according to drugs.com include nausea, vomiting, decreased appetite, diarrhea, seizures, hallucinations, a light “halo” around objects, green or yellow vision, fatigue, and an irregular heartbeat.  #

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