"The US Food and Drug Administration (FDA) has received multiple adverse event reports associated with the use of the Vascu-Guard Peripheral Vascular Patch (Baxter International Inc) during carotid endarterectomy (CEA).
In post-myocardial infarction patients with asymptomatic PVCs and non-sustained ventricular tachycardia, TAMBOCOR (flecainide) therapy was found to be associated with a 5.1% rate of death and non-fatal cardiac arrest, compared with a 2.3% rate in a matched placebo group. (See WARNINGS.)
Adverse effects reported for TAMBOCOR (flecainide) , described in detail in the Warnings section, were new or worsened arrhythmias which occurred in 1% of 108 patients with PSVT and in 7% of 117 patients with PAF; and new or exacerbated ventricular arrhythmias which occurred in 7% of 1330 patients with PVCs, non-sustained or sustained VT. In patients treated with flecainide for sustained VT, 80% (51/64) of proarrhythmic events occurred within 14 days of the onset of therapy. 198 patients with sustained VT experienced a 13% incidence of new or exacerbated ventricular arrhythmias when dosage was initiated at 200 mg/day with slow upward titration, and did not exceed 300 mg/day in most patients. In some patients, TAMBOCOR (flecainide) treatment has been associated with episodes of unresuscitatable VT or ventricular fibrillation (cardiac arrest). (See WARNINGS.) New or worsened CHF occurred in 6.3% of 1046 patients with PVCs, non-sustained or sustained VT. Of 297 patients with sustained VT, 9.1% experienced new or worsened CHF. New or worsened CHF was reported in 0.4% of 225 patients with supraventricular arrhythmias. There have also been instances of second- (0.5%) or third-degree (0.4%) AV block. Patients have developed sinus bradycardia, sinus pause, or sinus arrest, about 1.2% altogether (see WARNINGS). The frequency of most of these serious adverse events probably increases with higher trough plasma levels, especially when these trough levels exceed 1.0μg/mL.
There have been rare reports of isolated elevations of serum alkaline phosphatase and isolated elevations of serum transaminase levels. These elevations have been asymptomatic and no cause and effect relationship with TAMBOCOR (flecainide) has been established. In foreign postmarketing surveillance studies, there have been rare reports of hepatic dysfunction including reports of cholestasis and hepatic failure, and extremely rare reports of blood dyscrasias. Although no cause and effect relationship has been established, it is advisable to discontinue TAMBOCOR (flecainide) in patients who develop unexplained jaundice or signs of hepatic dysfunction or blood dyscrasias in order to eliminate TAMBOCOR (flecainide) as the possible causative agent.
Incidence figures for other adverse effects in patients with ventricular arrhythmias are based on a multicenter efficacy study, utilizing starting doses of 200 mg/day with gradual upward titration to 400 mg/day. Patients were treated for an average of 4.7 months, with some receiving up to 22 months of therapy. In this trial, 5.4% of patients discontinued due to non-cardiac adverse effects.
Table 1 Most Common Non-Cardiac Adverse Effects in
Ventricular Arrhythmia Patients Treated with TAMBOCOR (flecainide) in the Multicenter Study
All 429 Patients at Any Dose
|Incidence by Dose During Upward Titration|
|* Dizziness includes reports of dizziness, lightheadedness, faintness, unsteadiness, near syncope, etc.
†Visual disturbance includes reports of blurred vision, difficulty in focusing, spots before eyes, etc.
The following additional adverse experiences, possibly related to TAMBOCOR (flecainide) therapy and occurring in 1% to less than 3% of patients, have been reported in acute and chronic studies: Body as a Whole– malaise, fever; Cardiovascular– tachycardia, sinus pause or arrest; Gastrointestinal– vomiting, diarrhea, dyspepsia, anorexia; Skin– rash; Visual– diplopia; Nervous System– hypoesthesia, paresthesia, paresis, ataxia, flushing, increased sweating, vertigo, syncope, somnolence, tinnitus; Psychiatric– anxiety, insomnia, depression.
The following additional adverse experiences, possibly related to TAMBOCOR (flecainide) , have been reported in less than 1% of patients: Body as a Whole– swollen lips, tongue and mouth; arthralgia, bronchospasm, myalgia; Cardiovascular– angina pectoris, seconddegree and third-degree AV block, bradycardia, hypertension, hypotension; Gastrointestinal– flatulence; Urinary System– polyuria, urinary retention; Hematologic– leukopenia, granulocytopenia, thrombocytopenia; Skin– urticaria, exfoliative dermatitis, pruritis, alopecia; Visual– eye pain or irritation, photophobia, nystagmus; Nervous System– twitching, weakness, change in taste, dry mouth, convulsions, impotence, speech disorder, stupor, neuropathy; Respiratory– pneumonitis/pulmonary infiltration possibly due to chronic flecainide treatment; Psychiatric– amnesia, confusion, decreased libido, depersonalization, euphoria, morbid dreams, apathy. For patients with supraventricular arrhythmias, the most commonly reported noncardiac adverse experiences remain consistent with those known for patients treated with TAMBOCOR (flecainide) for ventricular arrhythmias. Dizziness is possibly more frequent in PAF patients.
Read the Tambocor (flecainide) Side Effects Center for a complete guide to possible side effects
TAMBOCOR (flecainide) has been administered to patients receiving digitalis preparations or beta-adrenergic blocking agents without adverse effects. During administration of multiple oral doses of TAMBOCOR (flecainide) to healthy subjects stabilized on a maintenance dose of digoxin, a 13% - 19% increase in plasma digoxinlevels occurred at six hours postdose. In a study involving healthy subjects receiving TAMBOCOR and propranolol concurrently, plasma flecainide levels were increased about 20% and propranolol levels were increased about 30% compared to control values. In this formal interaction study, TAMBOCOR (flecainide) and propranolol were each found to have negative inotropic effects; when the drugs were administered together, the effects were additive. The effects of concomitant administration of TAMBOCOR (flecainide) and propranolol on the PR interval were less than additive. In TAMBOCOR (flecainide) clinical trials, patients who were receiving beta blockers concurrently did not experience an increased incidence of side effects. Nevertheless, the possibility of additive negative inotropic effects of beta blockers and flecainide should be recognized.
Flecainide is not extensively bound to plasma proteins. In vitro studies with several drugs which may be administered concomitantly showed that the extent of flecainide binding to human plasma proteins is either unchanged or only slightly less. Consequently, interactions with other drugs which are highly protein bound (e.g., anticoagulants) would not be expected. TAMBOCOR (flecainide) has been used in a large number of patients receiving diuretics without apparent interaction. Limited data in patients receiving known enzyme inducers (phenytoin, phenobarbital, carbamazepine) indicate only a 30% increase in the rate of flecainide elimination. In healthy subjects receiving cimetidine (1 gm daily) for one week, plasma flecainide levels increased by about 30% and half-life increased by about 10%.
When amiodarone is added to flecainide therapy, plasma flecainide levels may increase two-fold or more in some patients, if flecainide dosage is not reduced. (See DOSAGE AND ADMINISTRATION)
Drugs that inhibit cytochrome P450IID6, such as quinidine, might increase the plasma concentrations of flecainide in patients that are on chronic flecainide therapy; especially if these patients are extensive metabolizers.
There has been little experience with the coadministration of TAMBOCOR (flecainide) and either disopyramide or verapamil. Because both of these drugs have negative inotropic properties and the effects of coadministration with TAMBOCOR (flecainide) are unknown, neither disopyramide nor verapamil should be administered concurrently with TAMBOCOR (flecainide) unless, in the judgment of the physician, the benefits of this combination outweigh the risks. There has been too little experience with the coadministration of TAMBOCOR (flecainide) with nifedipine or diltiazem to recommend concomitant use.
Read the Tambocor Drug Interactions Center for a complete guide to possible interactions
Last reviewed on RxList: 4/20/2009
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