More Oversized Digoxin Tablets Recalled; Possibility of Overdoses Feared

Digoxin heart pills are being recalled again due to concerns they may be oversized and contain potentially deadly amounts of the active ingredient, the Food and Drug Administration said.

The recall involves all Caraco brand digoxin, packaged and sold by A S Medication Solutions, LLC, before March 31, 2009 with an expiration date of August 2011, the FDA said. The tablets may differ in size and could have either more or less digoxin than is indicated on the label.

Digoxin is a drug commonly prescribed to treat abnormal heartbeat and heart failure. Too much digoxin can cause a disease called digoxin toxicity in patients with renal failure. Symptoms of digoxin toxicity include vomiting, nausea, dizziness, low blood pressure, slow heart rate, and cardiac instability, the FDA said.

Low levels of digoxin may lead to heart failure and abnormal heart rhythms. Since patients taking digoxin tend to be in poor overall health and suffer from other underlying medical problems, even slight variations in the amount of the drug in pills can have deadly consequences.

The Caraco digoxin pills involved in the FDA recall were sold in 0.25-mg tablets, which are scored round biconvex white and imprinted with “441.” The tablets were available in 30-count bottles with the NDC code 54569-5758-0, the FDA said.

Other Digoxin Recalls

In April 2008, Digitek digoxin pills made by Actavis Totowa LLC were recalled after an unknown number of tablets were suspected of being double-sized and possibly carrying too much of the active ingredient. About a dozen reports of patient deaths and injuries were linked to the double-dose Digitek digoxin pills.

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