Patients suffering from heart failure may face a higher risk of death when they take the heart drug digoxin, according to the findings of new research.
In a study published this month in the medical journal Circulation: Cardiovascular Quality and Outcomes, researchers from Kaiser Permanente found that patients who suffered heart failure and were newly placed on digoxin were more likely to die than those not given the drug.
Digoxin is commonly used to treat congestive heart failure, abnormal heart rhythms, atrial flutter and atrial fibrillation. The medication is extremely dose-specific, with a narrow therapeutic index. If too little of drug is prescribed it can be ineffective, and if too much is prescribed, it can lead to a digoxin overdose, where the drug builds up in the system. This can result in a serious and potentially life-threatening condition known as digitalis toxicity.
Studies Raise Safety Concerns
A number of recent studies suggest that digoxin may be dangerous for the very patients it is supposed to help. In November 2012, a study in the European Heart Journal found that digoxin could increase the risk of death for patients suffering from atrial fibrillation, a heart rhythm problem. Another study, published in June 2010 in the Journal of the American Society of Nephrology, found an increased risk of death among dialysis patients given the heart drug.
This latest study looked at 529 patients given digoxin between 2006 and 2008 and conducted 2.5 years of follow up. According to the findings, there were 14.2 deaths for every 100 patient-years among those given digoxin, compared to only 11.3 patient deaths among those not given the drug. There was also a higher rate of hospitalization, but it was deemed not statistically significant.
Researchers calculated in factors such as medical history, other medications, severity of heart failure and other factors to make their findings more accurate. They determined that digoxin increased the risk of death among heart failure patients by 72%.
In April 2008, Actavis Totowa issued a Digoxin recall for all lots of its generic version, Digitek, after it was discovered that some tablets may have been commercially released that were twice as thick as they were supposed to be. The error potentially exposed thousands of users to a risk of digoxin overdose or poisoning.
According to a December 2008 report released by the non-profit Center for Public Justice, the FDA received reports of at least 667 digoxin overdose deaths tied to the recalled pills between April 2008 and June 2008.
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