An article published online recently in the journal Circulation: Cardiovascular Quality and Outcomes found a 72 percent increase in death in heart failure patients treated with Lanoxin (digoxin) compared to those who had never taken the drug.
Digoxin is used to treat patients with moderate heart failure and abnormal heart rhythms (arrhythmias), Drug Safety Monitor reports. It improves the strength and efficiency of the heart for better blood circulation and reduced swelling of the hands and ankles in patients with heart problems, according to the Mayo Clinic. Lanoxin, manufactured by GlaxoSmithKline, is an injectable medication. The U.S. Food and Drug Administration (FDA) approved Lanoxin on September 30, 1997.
The research study included 2,891 adult patients, all newly diagnosed with systolic heart failure between the years 2006 and 2008. None of the patients had been treated with digoxin before the start of the study. A total of 529 patients were treated with digoxin during the trial period. The researchers found that digoxin treatment was associated with increased mortality but noted no significant difference in heart failure-related hospitalizations.
According to Drug Safety Monitor, the most commonly reported side effects of digoxin are toxicity to various agents, nausea, and dizziness. Through analysis of adverse events in the FDA Adverse Events Reporting System (FAERS), Drug Safety Monitor identified 4,893 hospitalizations and 2,727 patient deaths where Lanoxin or generic digoxin was indicated as the primary suspect.
The researchers, who are from Stanford, from Kaiser Permanante’s research division, and from the University of California at San Francisco, concluded that clinical guidelines for the use of digoxin may need to be revised in order to ensure patient safety.