Monday, May 5, 2008

FDA issues Class 1 Recall FDA for Digitek (digoxin)


A very important nationwide Class I recall of all strengths of Digitek, a drug used to treat heart failure and abnormal heart rhythms was issued April 29,2008. Digitek(digoxin) products are distributed by Mylan Pharmaceuticals Inc., under a "Bertek" label and by UDL Laboratories, Inc. Digitek is being recalled due to the possibility that tablets with double the appropriate thickness may contain twice the approved level of digoxin. Digoxin is one of the medications that are known as having "a narrow therapeutic window." This basically means that there is only a small gap between the dose that is considered therapeutic and the dose that be toxic.Therefore,changes in dosage must be monitored closely. Several reports of illnesses and injuries have been reported. That is why this is considered a Class I Recall. The existence of double strength tablets poses a risk of digitalis toxicity in patents with renal failure. Digitalis toxicity can cause nausea, vomiting, dizziness, low blood pressure, cardiac instability and bradycardia.Some patients may also experience seeing a "halo" effect(yellow ring around lights) . Patients should contact their healthcare professional with questions.





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