Digitek Heart Drug Recalled over Double Dosage Risk

By Anna Boyd
13:45, April 30th 2008
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Digitek Heart Drug Recalled over Double Dosage Risk

A widely used drug in heart failure and abnormal heart rhythms patients has been recalled because of a potential safety risk.

According to the U.S. Food and Drug Administration, Actavis Totowa LLC, formerly known as Amide Pharmaceutical Inc of Totowa, N.J. reported some tablets of Digitek-brand digoxin might contain twice the approved level of active ingredient.

Also, “several reports of illnesses and injuries have been received” in connection with the tablets, according to a notice posted Monday on the FDA’s Web site. However, no fatalities were reported.

The double dosage could cause nausea, vomiting, dizziness, low blood pressure, as well as heart problems and may pose a risk of digitalis toxicity in patients with renal failure. Excessive digitalis intake could also result in death.

The products are distributed by Mylan Pharmaceuticals Inc. under a "Bertek" label and by UDL Laboratories Inc. under a "UDL" label.

John LaRocca, Actavis’ general counsel said, “there’s been nothing of a serious nature,” but he declined to comment on what may have caused the tablets to contain too much medicine.

Anyone facing adverse reactions from the drug should report them at the FDA’s Med Watch program at 1-800-FDA-0178 or online at http://www.fda.gov/medwatch/report. Also, patients seeking information can call Actavis at 1-888-276-6166.



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