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Hissey Kientz Concerned That Patients Have Not Been Provided With Crucial Information About Digitek Recall Despite the Dangers of Digoxin Toxicity
Date:8/16/2008

roblems connected with the http://www.hkllp.com/digitek/digitek-recall.html [Digitek recall],” says attorney Mike Hissey with Hissey Kientz, LLP in Austin, Texas. “The public has a right to know how long this problem has been going on and how many patients could be affected. Many consumers were only made aware of the problems with Digitek when their pharmacist or doctor told them about the recall notice.”

Digitek is prescribed to patients with heart problems in order to treat congestive heart failure, an irregular heartbeat or other symptoms. Digitek is a form of the heart medication digitalis, which helps to strengthen the beating of the heart muscles and relieve the symptoms of patients with these conditions. It is also known generically as digoxin.

However, when administered in too high of a dose, digoxin drugs such as Digitek may cause digoxin toxicity, resulting in an overdose. Symptoms of a http://www.hkllp.com/digitek/digitek-side-effects.html [Digitek overdose] include unusual changes in vision, dizziness, irregular heartbeat, abnormally low blood pressure or heart rate, nausea, vomiting or other symptoms. In severe cases, digoxin toxicity can lead to a heart attack or stroke, which can result in death.

The FDA sent warning letters to Actavis in September 2006 and February 2007 after the agency uncovered manufacturing problems at the plant where Digitek is produced. The FDA stated in these letters that because of quality control problems at the plant, drugs made there were “adulterated,” making it impossible to determine if they were being manufactured at the correct strength.

Actavis also issued a recall notice on August 1, 2008 for every single drug produced at the New Jersey plant where Digitek was manufactured. The recall n
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Hissey Kientz Concerned That Patients Have Not Been Provided With Crucial Information About Digitek Recall Despite the Dangers of Digoxin Toxicity
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