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Executive Summary

ANTI-ARRHYTHMIC USE LIMITED TO LIFE-THREATENING ARRHYTHMIAS in proposed new labeling, FDA Division of Cardio-Renal Drugs Director Raymond Lipicky, MD, reported to the Dec. 14 meeting of the Cardio-Renal Drugs Advisory Committee. Proposed labeling for all anti-arrhythmic drugs that would read: "X is indicated for the treatment of documented ventricular arrhythmias such as sustained ventricular tachycardia that in the judgment of the physician are life-threatening. Because of the proarrhythmic effects of X, its use should be reserved for patients in whom, in the opinion of the physician, the benefits of treatment outweigh the risks." The committee responded to the FDA proposed labeling with the view that it may be too restrictive and that physicians should have the option of treating patients with symptomatic arrhythmias with anti-arrhythmics. Committee member Edward Pritchett, MD, Duke University Medical Center, stated that "it was the sense of the committee that we wanted to preserve some room for the attending physician to manuever to treat patients who had what the patient perceived to disabling symptoms and accept that there may be some risk." FDA drafted new labeling in response to a recommendation made by the Cardio-Renal Drugs Advisory Committee at its Oct. 5, 1989 meeting. At that time, the committee concluded that based on the results of the Cardiac Arrhythmia Suppression Trial (CAST) that Class 1 C anti-arrhythmics should be limited to treating life-threatening arrhythmias and that Class 1 A and 1 B anti-arrhythmics should be indicated only for life-threatening and symptomatic arrhythmias ("The Pink Sheet" Oct. 9, 1989, p. 4). FDA proposed that following the description of the CAST results labeling should read: "the applicability of these results to other populations -- e.g. those without recent myocardial infarctions or those treated with other anti-arrhythmic drugs -- is uncertain. At present it is prudent to consider any anti-arrhythmic agent, especially one documented to provoke new series arrhythmias or worsening of pre-existing arrhythmias, to have similar risks and to consider the risks of the anti-arrhythmic agents coupled with the lack of any evidence of improved survival generally unacceptable in patients without life-threatening arrhythmias even if the patients are experiencing unpleasant symptoms." Lipicky explained the reason why FDA proposed restrictive labeling. He said that the agency has become aware of "a meta-analysis of quinidine's use in chronic VTC trials and basically that analysis comes to the conclusion that quinidine is worse than encainide or any of the other newer agents from the vantage point of mortality." Lipicky noted that there are two other studies of quinidine, one of them is published. Quinidine is a 1 C anti-arrhythmic. The FDAer added that although he has not seen the meta-analysis, he is willing to assume that "if one is using an agent that has negative inotropic effects and or pro-arrhythmic effects and has not demonstrated an increase in survival as a consequence of their use in some arrhythmia, the probabilities are that if it's used in the wrong patient population, the wrong arrhythmia, there will in fact be that adverse effect." Despite this additional information on the adverse effects of anti-arrhythmics, the committee still wanted to loosen the labeling's language so physicians could have the option of treating symptomatic arrhythmias. Summarizing the committee's suggestion, Lipicky said that "rather than making the value judgment that it is 'generally unacceptable,' make the statement that it would be prudent to consider that these guys carry risks and that consideration of these risks should be undertaken if treating someone other than patients with life-threatening arrhythmias." Committee members suggested adding a statement that anti-arrhythmics should not be used in treating patients with asymptomatic ventricular arrhythmias. Lipicky said he would have to consider whether such a prohibitive statement should be included in labeling.

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