Study Links Digoxin with 20% Increased Risk of Death

Another new study raises concerns about the potential side effects of digoxin, linking the popular hear drug to an increased risk of death among patients with atrial fibrillation. 

Researchers from Duke University presented the findings of an analysis into clinical trial data over the drug at the European Society of Cardiology Congress in Barcelona, Spain earlier this month.

The researchers, lead by Dr. Manesh Patel, determined that digoxin has not been studied well enough in randomized clinical trials and called for more studies.

Their own findings indicated that giving digoxin to patients with atrial fibrilliation increased their risk of death by 22%, when compared to patients not taking the drug. The study has not yet been published for peer review.

According to the researchers, digoxin may be a danger to patients and only extensive randomized clinical trials could determine the extent of its risks and benefits.

Digoxin Death Risk

This research is at least the fourth major study in recent years that has linked digoxin side effects to an increased risk of patient deaths.

The study comes on the heels of findings published in the Journal of the American College of Cardiology in August, which found those prescribed digoxin were 26% more likely to die over the next four years. That translated to 95 deaths per 1,000 person-years for those given digoxin, compared with 67 per 1,000 person-years among those not given the heart drug.

Researchers from the United Kingdom came to similar conclusions in a study published in the European Heart Journal in November 2012, examining data involving 4,000 patients. The study found that there was a 41% increased risk of death among AF patients given the digoxin.

In a study published in June 2010, side effects of digoxin were linked to an increased risk of death among patients undergoing dialysis treatment, with the findings suggesting that the risk was dose-related, with higher rates of death found among dialysis patients given hire doses of the drug.

More recently, a study published in the medical journal Circulation: Cardiovascular Quality and Outcomes in September 2013, found that heart failure patients given digoxin were more likely to die than other patients.

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.

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.