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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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