The cardiac or digitalis glycosides are a closely related group of drugs having in common specific effects on the myocardium. These drugs are found in several plants and animals. The term digitalis is used to designate the whole group. Digoxin, which is extracted from the leaves of Digitalis lanata, was reportedly discovered and developed in 1930 at the Wellcome Chemical Works at Dartford. Digoxin has been used in the treatment of certain cardiac disorders for many years and labeled for use in heart failure, atrial fibrillation, atrial flutter, and paroxysmal atrial tachycardia.
Digoxin is available for oral and intravenous administration.
This notice addresses digoxin tablets and elixir. Because of bioavailability problems found to exist with digoxin tablets, FDA has sought, over the years, to provide a systematic regulatory approach to ensure the uniformity of all marketed, oral digoxin products. In April 1970, FDA began a program to systematically test marketed lots of digoxin tablets. FDA took this action after the agency became aware of an apparent potency problem with this cardiac glycoside. As a result of this testing program, from April to November 1970, there were 79 recalls of digoxin products.