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CORVERT® (ibutilide fumarate) Adverse Reactions

ADVERSE REACTIONS

CORVERT Injection was generally well tolerated in clinical trials. Of the 586 patients with atrial fibrillation or atrial flutter who received CORVERT in phase II/III studies, 149 (25%) reported medical events related to the cardiovascular system, including sustained polymorphic ventricular tachycardia (1.7%) and nonsustained polymorphic ventricular tachycardia (2.7%).

Other clinically important adverse events with an uncertain relationship to CORVERT include the following (0.2% represents one patient): sustained monomorphic ventricular tachycardia (0.2%), nonsustained monomorphic ventricular tachycardia (4.9%), AV block (1.5%), bundle branch block (1.9%), ventricular extrasystoles (5.1%), supraventricular extrasystoles (0.9%), hypotension/postural hypotension (2.0%), bradycardia/sinus bradycardia (1.2%), nodal arrhythmia (0.7%), congestive heart failure (0.5%), tachycardia/sinus tachycardia/supraventricular tachycardia (2.7%), idioventricular rhythm (0.2%), syncope (0.3%), and renal failure (0.3%). The incidence of these events, except for syncope, was greater in the group treated with CORVERT than in the placebo group.

Another adverse reaction that may be associated with the administration of CORVERT was nausea, which occurred with a frequency greater than 1% more in ibutilide-treated patients than those treated with placebo.

The medical events reported for more than 1% of the placebo- and ibutilide-treated patients are shown in the following Table.

Treatment-Emergent Medical Events With Frequency of More Than 1% and Higher Than That of Placebo
Event Placebo
N=127
All Ibutilide
N=586
Patients Patients
n % n %
CARDIOVASCULAR
  Ventricular extrasystoles 1 0.8 30 5.1
  Nonsustained monomorphic VT 1 0.8 29 4.9
  Nonsustained polymorphic VT 16 2.7
  Hypotension 2 1.6 12 2.0
  Bundle branch block 11 1.9
  Sustained polymorphic VT 10 1.7
  AV block 1 0.8 9 1.5
  Hypertension 7 1.2
  QT segment prolonged 7 1.2
  Bradycardia 1 0.8 7 1.2
  Palpitation 1 0.8 6 1.0
  Tachycardia 1 0.8 16 2.7
GASTROINTESTINAL
  Nausea 1 0.8 11 1.9
CENTRAL NERVOUS SYSTEM
  Headache 4 3.1 21 3.6

In the post-cardiac surgery study (see CLINICAL STUDIES), similar types of medical events were reported. In the 1 mg ibutilide fumarate treatment group (N=70), 2 patients (2.9%) developed sustained polymorphic ventricular tachycardia and 2 other patients (2.9%) developed nonsustained polymorphic ventricular tachycardia. Polymorphic ventricular tachycardia was not reported in the 73 patients in the 0.5 mg dose group or in the 75 patients in the 0.25 mg dose group.

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