Side Effects of Digoxin May Up Risk of Death Among A-Fib Patients: Study

The heart drug digoxin may increase the risk of death when given to patients with atrial fibrillation, according to the findings of a new study.  

Researchers from the United Kingdom published a study this week in the European Heart Journal, which raises serious questions about the potential side effects of digoxin and the effectiveness of the heart medication.

Digoxin has long been used to treat patients with atrial fibrillation, but the findings of the study suggest that it may result in serious and potentially fatal problems for some patients, instead of helping them.

Researchers looked at data from 4,060 atrial fibrillation patients who were part of the Atrial Fibrillation Follow-Up Investigation of Rhythm Management (AFFIRM) trial. According to the findings, there was a 41% increase in deaths among patients given the drug. That included a 35% increase in the rate of death due to cardiovascular causes of any kind, and a 61% increase in the rate of death attributed to heart rhythm problems.

In a press release by the European Society of Cardiology, Samy Claude Elayi, lead researcher and professor of medicine at the Gill Heart Institute, said the findings should make doctors question the drug’s widespread use.

“These findings mean that physicians should try to control a patient’s heart rate by using alternatives as a first line, such as beta-blockers or calcium blockers,” Elayi said. ” Patients should be aware of potential toxicity and see their physicians immediately in specific clinical situations, for instance if they experience palpitations or syncope, as those may precede arrhythmic death.”

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.

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.