Evolution and revolution in drug labeling: Regulation of antiarrhythmic drugs by the food and drug administration 1962-1996

PACE - Pacing and Clinical Electrophysiology

Volumn 21, Issue 7, 1998, Pages 1457-1469

  Pritchett, Edward L C ^a  

^a DUKE UNIVERSITY MEDICAL CENTER   (United States)

Author keywords

Adrenergic beta antagonists; Antiarrhythmia agents; Arrhythmia; Atrial fibrillation; Calcium channel blockers; Cardiac tachycardia; Death; Sudden; Supraventricular tachycardia; Ventricular; Ventricular fibrillation

Indexed keywords

AMIODARONE; ANTIARRHYTHMIC AGENT; BETA ADRENERGIC RECEPTOR BLOCKING AGENT; BIDISOMIDE; BRETYLIUM; CALCIUM CHANNEL BLOCKING AGENT; DIGOXIN; DISOPYRAMIDE; ENCAINIDE; FLECAINIDE; LIDOCAINE; PROCAINAMIDE; PROPRANOLOL; QUINIDINE; VERAPAMIL;

CLINICAL TRIAL; DRUG APPROVAL; DRUG EFFICACY; DRUG INDUSTRY; DRUG LABELING; DRUG LEGISLATION; DRUG RESEARCH; ELECTROCARDIOGRAPHY MONITORING; FOOD AND DRUG ADMINISTRATION; HEART ARRHYTHMIA; HEART ATRIUM FIBRILLATION; HEART VENTRICLE EXTRASYSTOLE; HEART VENTRICLE TACHYCARDIA; HUMAN; REVIEW; SUDDEN DEATH;

ANTI-ARRHYTHMIA AGENTS; ARRHYTHMIA; DRUG APPROVAL; DRUG LABELING; HISTORY, 20TH CENTURY; HUMANS; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 0031878840     PISSN: 01478389     EISSN: None     Source Type: Journal    
DOI: 10.1111/j.1540-8159.1998.tb00218.x     Document Type: Review

References (73)

1. Wax PM. Elixirs, diluents, and the passage of the 1938 Federal Food, Drug and Cosmetic Act. Ann Intern Med 1995; 122,6:456-62.
2. Wardell WM. History and application of drug safety and efficacy requirements in the United States. Agents and Actions 1978; 8:420-421.
3. Drug Efficacy Study. Final Report to the Commissioner of Food and Drugs, Food and Drug Administration, from the Division of Medical Sciences, National Research Council. Washington, DC: National Academy of Sciences, 1969.
4. Wardell WM. The US drug efficacy study and its implication (DESI). Agents and Actions 1978; 8:420-421.
5. Kaitin KI, Melville A, Morris B. FDA Advisory Committees and the New Drug Approval Process. J Clin Pharmacol 1989; 29:886-890.
6. Burroughs Wellcome & Co. MD. "Lanoxin" brand digoxin: A cardiotonic glycoside of unique flexibility, discovered and developed by The Wellcome Research Laboratories. Tuckahoe, New York, Burroughs Wellcome & Co., Medical Department, 1965.
7. Estes JW. Hall Jackson and the Purple Foxglove: Medical Practice and Research in Revolutionary America 1760-1829. Hanover, New Hampshire, University Press of New England, 1979.
8. Certain drugs containing acetyldigitoxin, deslanoside, digitoxin, or digoxin. Federal Register 1972; 37,145:15024-15026.
9. Rules and Regulations Title 21 Food and Drugs; Chapter I-Food and Drug Administration, Department of Health, Education, and Welfare; Subchapter C Drugs; Part 130-New Drugs; Conditions for Marketing of Digoxin Products. Federal Register 1974; 39,15:2471-2479.
10. Certain anti-arrhythmic drugs containing quinidine hydrochloride; isoproterenol hydrochloride; procainamide hydrochloride; quinidine sulfate; or quinidine gluconate. Federal Register 1972; 37, 175:18227-18229.
11. Kaitin KI, Mattison N, Northington FK, et al. The drug lab: An update of new drug introductions in the United States and in the United Kingdom, 1977 through 1987. Clin Pharmacol Ther 1989; 46(II):121-138.
12. Inderal. In: Physicians' Desk Reference to Pharmaceutical Specialties and Biologicals. 22nd ed. Oradell, New Jersey, Medical Economics, Inc., 1968, pp. A19-A20.
13. Luria MH, Adelson EI, Miller AJ. Acute and chronic effects of an adrenergic beta-receptor blocking agent (propranolol) in treatment of cardiac arrhythmias. Circulation 1966; 34:767-773.
14. Gianelly RE, Griffin JR, Harrison DC. Propranolol in the treatment and prevention of cardiac arrhythmias. Ann Intern Med 1966; 66:667-676.
15. Beta-Blocker Heart Attack Study Group. The Beta-Blocker Heart Attack Trial. JAMA 1981; 246: 2073-2074.
16. Beta-Blocker Heart Attack Trial Research Group. A randomized trial of propranolol in patients with acute myocardial infarction: I. Mortality results. JAMA 1982; 247:1707-1714.
17. Bernstein JG, Koch-Weser J. Effectiveness of bretylium tosylate against refractory ventricular arrhythmias. Circulation 1972; XLV:1024-1034.
18. Cohen HC, Gozo EG Jr, Langendorf R, et al. Response of resistant ventricular tachycardia to bretylium: Relation to site of ectopic focus and location of myocardial disease. Circulation 1973; XLVII:331-340.
19. Koch-Weser J. Drug therapy: Bretylium. N Engl J Med 1979; 300:473-477.
20. Work of Cardiology Community Results in Approval of Amiodarone. FDA Drug Bulletin, Department of Health & Human Services 1986; 16,1:4-5.
21. Bigger JT Jr, Fleiss JL, Kleiger R, et al. Multicenter Post-Infarction Research Group. The relationships among ventricular arrhythmias, left ventricular dysfunction, and mortality in the 2 years after myocardial infarction. Circulation 1984; 69(2):250-258.
22. Mukharji J, Rude RE, Poole WK, et al. Risk factors for sudden death after acute myocardial infarction: Two-year follow-up. Am Journal Cardiol 1984; 1984(54):31-36.
23. Kannel WB, Thomas HE. Sudden coronary death: The Framingham Study. Ann N Y Acad Sci 1982; 382:3-21.
24. Chiang BN, Perlman LV, Fulton M. Predisposing factors in sudden cardiac death in Tecumseh, Michigan. A prospective study. Circulation 1970; 41:31-37.
25. Ruberman W, Weinblatt E, Goldberg JD, et al. Ventricular premature beats and mortality after myocardial infarction. N Engl J Med 1977; 297:750-757.
26. Guidelines for the Clinical Evaluation of Anti-Arrhythmic Drugs, HEW (FDA) 78-3048. Rockville, MD: Food and Drug Administration, 1978.
27. Holter NJ. New method for heart studies: Continuous electrocardiography of active subjects over long periods is now practical. Science 1961; 134:1214-1220.
28. Morganroth J. Ambulatory Holter electrocardiography: Choice of technologies and clinical uses. Ann Intern Med 1985; 102:73-81.
29. Morganroth J, Michelson EL, Horowitz LN, et al. Limitations of routine long-term electrocardiographic monitoring to assess ventricular ectopic frequency. Circulation 1978; 58:408-414.
30. Winkle RA. Antiarrhythmic drug effect mimicked by spontaneous variability of ventricular ectopy. Circulation 1978; 57:1116-1121.
31. Michelson EL, Morganroth J. Spontaneous variability of complex ventricular arrhythmias detected by long-term electrocardiographic recording. Circulation 1980; 61:690-695.
32. Pratt CM, Delclos G, Weirman AM, et al. The changing base line of complex ventricular arrhythmias: A new consideration in assessing long-term antiarrhythmic drug therapy. N Engl J Med 1985; 313:1444-1449.
33. Anastasiou-Nana MI, Menlove RL, Nanas JN, et al. Changes in spontaneous variability of ventricular ectopic activity as a function of time in patients with chronic arrhythmias. Circulation 1988; 78:286-295.
34. Fleming TR, DeMets DL. Surrogate end points in clinical trials: Are we being misled? Ann Intern Med 1996; 125:605-613.
35. Roden DM, Reele SB, Higgins SB, et al. Total suppression of ventricular arrhythmias by encainide: Pharmacokinetic and electrocardiographic characteristics. N Engl J Med 1980; 302:878-882.
36. Winkle RA. Measuring antiarrhythmic drug efficacy by suppression of asymptomatic ventricular arrhythmias. Ann Intern Med 1979; 91(3):480-482.
37. Mason JW, Winkle RA. Accuracy of the ventricular tachycardia-induction study for predicting long-term efficacy and inefficacy of antiarrhythmic drugs. N Engl J Med 1980; 303:1073-1077.
38. Swerdlow CD, Winkle RA, Mason JW. Determinants of survival in patients with ventricular tachyarrhythmias. N Engl J Med 1983; 308:1436-1442.
39. Wilber DJ, Garan H, Finkelstein D, et al. Out-of-hospital cardiac arrest: Use of electrophysiologic testing in the prediction of long-term outcome. N Engl J Med 1990; 318:19-24.
40. Mitchell LB, Duff HJ, Manyari DE, et al. A randomized clinical trial of the noninvasive and invasive approaches to drug therapy of ventricular tachycardia. N Engl J Med 1987; 317:1681-1687.
41. The NDA Pipeline-1984. 1984th ed. Chevy Chase, MD: F-D-C Development Corp. 1985.
42. The NDA Pipeline-1985. Chevy Chase, MD: F-D-C Development Corporation, 1986.
43. The NDA Pipeline-1986. Chevy Chase, MD: F-D-C Development Corporation, 1987.
44. The NDA Pipeline-1989. Chevy Chase, MD: F-D-C Reports, Inc. 1990.
45. The NDA Pipeline-1990. Chevy Chase, MD: F-D-C Reports, Inc. 1991.
46. Durrer D, Schoo L, Schuilenburg RM, et al. The role of premature beats in the initiation and the termination of supraventricular tachycardias in the Wolff-Parkinson-White syndrome. Circulation 1967; 36:644-650.
47. Goldreyer BN, Bigger JT Jr. Spontaneous and induced reentrant tachycardia. Ann Intern Med 1969; 70:87-98.
48. Wellens HJJ, Durrer D. The role of an accessory atrioventricular pathway in reciprocal tachycardia. Observations in patients with and without the Wolff-Parkinson-White syndrome. Circulation 1975; 41:58-72.
49. Sung RJ, Elser B, McAllister RG Jr. Intravenous verapamil for termination of re-entrant supraventricular tachycardias. Ann Intern Med 1980; 93:682-689.
50. Stambler BS, Wood MA, Ellenbogen KA, et al. Efficacy and safety of repeated intravenous doses of ibutilide for rapid conversion of atrial flutter of fibrillation. Circulation 1996; 94:1613-1621.
51. CAST Investigators. Preliminary report: Effect of encainide and flecainide on mortality in a randomized trial of arrhythmia suppression after myocardial infarction. N Engl J Med 1989; 321:406-412.
52. Echt DS, Liebson PR, Mitchell LB, et al. Mortality and morbidity in patients receiving encainide, flecainide, or placebo. N Engl J Med 1991; 324:781-788.
53. Cardiac Arrhythmia Suppression Trial II Investigators. Effect of the antiarrhythmic agent moricizine on survival after myocardial infarction. N Engl J Med 1992; 1992(327):227-233.
54. Epstein AE, Hallstrom AP, Rogers WJ, et al. Mortality following ventricular arrhythmia suppression by encainide, flecainide, and moricizine after myocardial infarction. JAMA 1996; 270:2451-2455.
55. Pratt CM, Brater DC, Harrell FE, et al. Clinical and regulatory implications of the cardiac arrhythmia suppression trial. Am J Cardiol 1990; 65:103-105.
56. Waldo AL, Camm AJ, deRuyter H, et al. Effect of dsotalol on mortality in patients with left ventricular dysfunction after recent and remote myocardial infarction. Lancet 1996; 348:7-12.
57. Julian DG, Camm AJ, Frangin G, et al. Randomised trial of effect of amiodarone on mortality in patients with left-ventricular dysfunction after recent myocardial infarction: EMIAT. Lancet 1997; 349:667-674.
58. Cairns JA, Connolly SJ, Roberts R, et al. Randomised trial of outcome after myocardial infarction in patients with frequent or repetitive ventricular premature depolarisation: CAMIAT. Lancet 1997; 349:675-682
59. Teo KK, Yusuf S, Furberg CD. Effects of prophylactic antiarrhythmic drug therapy in acute myocardial infarction. An overview of results from randomized controlled trials. JAMA 1993; 270:1589-1595.
60. Mauritson DR, Winniford MD, Walker WS, et al. Oral verapamil for paroxysmal supraventricular tachycardia. Ann Intern Med 1982; 96:409-412.
61. Midtbo K. Verapamil in the prophylactic treatment of paroxysmal supraventricular tachycardia. Curr Ther Res 1983; 30:372-377.
62. Pritchett ELC, Hammill SC, Reiter MJ, et al. Life-table methods for evaluating antiarrhythmic drug efficacy in patients with paroxysmal atrial tachycardia. Am J Cardiol 1983; 52:1007-1012.
63. Anderson JL, Gilbert EM, Alpert BL, et al. Prevention of symptomatic recurrences of paroxysmal atrial fibrillation in patients initially tolerating antiarrhythmic therapy. A multicenter, double-blind, crossover study of flecainide and placebo with transtelephonic monitoring. Circulation 1989; 80:1557-1570.
64. Henthorn RW, Waldo AL, Anderson JL, et al. Flecainide acetate prevents recurrence of symptomatic paroxysmal supraventricular tachycardia. Circulation 1991; 83:119-125.
65. Tambocor. In: Physicians' Desk Reference. 47th ed. Montvale, New Jersey, Medical Economics Co., Inc., 1993, pp. 1355-1358.
66. Quinaglute. In: Physicians' Desk Reference. 51st ed. Montvale, New Jersey, Medical Economics Co., Inc., 1997, pp. 644-646.
67. Petersen P, Boysen G, Godtfredsen J, et al. Placebo-controlled, randomised trial of warfarin and aspirin for prevention of thromboembolic complications in chronic atrial fibrillation. The Copenhagen AFASAK Study. Lancet 1989; 1:175-179.
68. Boston Area Anticoagulation Trial for Atrial Fibrillation Investigators. The effect of low-dose warfarin on the risk of stroke in patients with non-rheumatic atrial fibrillation. N Engl J Med 1990; 323:1505-1511.
69. Connolly SJ, Laupacis A, Gent M, et al. Canadian atrial fibrillation anticoagulation (CAFA) study. J Am Coll Cardiol 1991; 18:349-355.
70. EAFT (European Atrial Fibrillation Trial) Study Group. Secondary prevention in non-rheumatic atrial fibrillation after transient ischaemic attack or minor stroke. Lancet 1993; 342:1255-1262.
71. Atrial Fibrillation Investigators. Risk factors for stroke and efficacy of antithrombotic therapy in atrial fibrillation: Analysis of pooled data from five randomized controlled trials. Arch Intern Med 1994; 154:1449-1457.
72. Stroke Prevention in Atrial Fibrillation Investigators. Warfarin versus aspirin for prevention of thromboembolism in atrial fibrillation: Stroke Prevention in Atrial Fibrillation II Study. Lancet 1994; 343:687-691.
73. Atrial Fibrillation with Bidisomide (AFIB) Investigators. Treatment of atrial fibrillation and paroxysmal supraventricular tachycardia with bidisomide. Circulation 1997; 96:2625-2632.