![]() The company markets digoxin under the brand names Lanoxin and Lanoxicaps. Burroughs Wellcome said the drug "is expected to meet an immediate life-saving need in the estimated 10,000-20,000 patients per year who experience severe, and often irreversible, digoxin and digitoxin intoxication." Digibind labeling notes that "although designed specifically to treat life-threatening digoxin overdose has also been used successfully to treat life-threatening digitoxin overdose." The labeling adds that "since human experience is limited and the consequences of repeated exposures are unknown, Digibind is not indicated for milder cases of digitalis toxicity." According to the labeling, "manifestations of life-threatening toxicity include severe ventricular arrhythmias such as ventricular tachycardia or ventricular fibrillation, or progressive bradyarrhythmias such as severe sinus bradycardia or second or third degree heart block not responsive to atropine." Burroughs Wellcome said it hopes to eventually broaden the indication for Digibind to include serious toxicity. Digibind (digoxin immune FAB (ovine)), approved as an orphan drug, is indicated "for treatment of potentially life-threatening digoxin intoxication," labeling states. ![]() EU Biosimilar Filings, Opinions & ApprovalsīURROUGHS WELLCOME'S ANTIDOTE TO DIGOXIN INTOXICATION, DIGIBIND, will be available to hospitals and poison control centers by the summer, the firm announced following approval of the drug May 8. ![]() Drug Review Pathways & Approval Standards.
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