Generic antiarrhythmics are not therapeutically equivalent for the treatment of tachyarrhythmias.
The consequences of antiarrhythmic drug formulation substitution were assessed by survey of 130 experts on arrhythmias. Fifty-four arrhythmia recurrences, 7 proarrhythmic events, and 3 deaths resulting from generic substitution are reported, thus raising serious concerns about both antiarrhythmic drug substitution and the adequacy of the generic drug approval process.
Reiffel
J A
JA
The Electrophysiology Service, Division of Cardiology, Department of Medicine, Columbia University and The New York Presbyterian Hospital, New York, NY, USA.
Kowey
P R
PR
D000638:Amiodarone / Q000493:pharmacokinetics / Q000627:therapeutic use; D000889:Anti-Arrhythmia Agents / Q000493:pharmacokinetics* / Q000627:therapeutic use; D019538:Health Care Surveys; D006801:Humans; D013610:Tachycardia / Q000188:drug therapy*; D013810:Therapeutic Equivalency
D000889:Anti-Arrhythmia Agents; D000638:Amiodarone