Procainamide Oral

07 November 2007

Products Affected - Description

All procainamide hydrochloride oral formulations, Bristol-Myers Squibb (Pronestyl), King Pharmaceuticals (Procanbid), Teva (generics)

Reason for the Shortage

• Bristol-Myers Squibb and Teva discontinued their oral procainamide products in 2006.^1,2
• King Pharmaceuticals discontinued Procanbid as of November 2, 2007. The company states this discontinuation is due to the availability of alternative antiarrhythmic agents, as well as the lack of necessity of this drug.³

Estimated Resupply Dates

All oral procainamide products are discontinued.

Implications for Patient Care

Procainamide is labeled for patients with life-threatening ventricular arrhythmias such as sustained ventricular tachycardia for whom the potential benefits outweigh the risks of serious hematologic adverse effects.⁴

Safety

Class IA antiarrhythmics such as procainamide do not improve survival and are arrhythmogenic.^4,5

Alternative Agents & Management

No single agent can be substituted for procainamide. Choose a therapeutic alternative based on patient-specific criteria and desired effect. The Table provides a summary of available oral antiarrhythmic agents.

Table. Summary of Available Oral Antiarrhythmic Agents^6-14

Agent	Classification	Comments
Acebutolol Hydrochloride	II	Therapeutic Uses: Prevent or suppress frequent ventricular premature complexes or R-on-T complexes. Management of hypertension.
Amiodarone	III	Therapeutic Uses: Maintenance of sinus rhythm in patients with significant left ventricular hypertrophy and congestive heart failure (CHF), symptomatic atrial fibrillation and CHF, cardiac arrest, acute sustained ventricular arrhythmias, reduce frequent implantable cardioverter-defibrillator (ICD) discharges, treatment of post-operative atrial fibrillation in patients receiving beta-blockers, perioperative prophylactic use after cardiac surgery, cardioversion of atrial fibrillation (alternative to dofetilide or ibutilide).
Disopyramide Phosphate	Ia	Therapeutic Uses: Life-threatening ventricular arrhythmias such as sustained ventricular tachycardia. Note: Disopyramide does not improve survival and is arrhythmogenic.
Dofetilide	III	Therapeutic Uses: Conversion of paroxysmal atrial fibrillation or atrial flutter, prevent recurrence of symptomatic atrial fibrillation or atrial flutter, or maintain sinus rhythm in patients with CHF. Note: Available through a restricted distribution program for clinicians and hospitals who complete documented eduction. Can precipitate torsades de pointes.
Flecainide Acetate	Ic	Therapeutic Uses: Life-threatening ventricular arrhythmias such as sustained ventricular tachycardia. Note: Flecainide does not improve survival and is arrhythmogenic.
Mexiletine Hydrochloride	Ib	Therapeutic Uses: Life-threatening ventricular arrhythmias such as sustained ventricular tachycardia. Note: Mexiletine does not improve survival and is arrhythmogenic.
Propafenone Hydrochloride	Ic	Therapeutic Uses - Immediate Release: Prolong recurrence of paroxysmal atrial fibrillation or atrial flutter in patients without structural heart disease. Therapeutic Uses - Extended Release: Prolong recurrence of symptomatic atrial fibrillation in patients with structural heart disease. Note: Not for use to control ventricular rate in patients with atrial fibrillation.
Quinidine Gluconate	Ia	Therapeutic Uses: Prophylaxis to maintain sinus rhythm after conversion of atrial fibrillation or atrial flutter, and to prevent atrial fibrillation, atrial tachycardia, AV junctional rhythm, and ventricular tachycardia. Note: Mortality rates for patients taking quinidine are 3 times higher than placebo.
Sotalol Hydrochloride	III	Therapeutic Uses: Life-threatening ventricular arrhythmias such as sustained ventricular tachycardia, convert atrial or ventricular tachyarrhythmias, maintain sinus rhythm in patients with atrial or ventricular tachyarrhythmias, adjunct therapy with ICD. Note: Can precipitate torsades de pointes unlike other beta adrenergic blocking agents.

Note: Moricizine, Procainamide, and Tocainide are discontinued

Related Shortages

• Isosorbide— Resolved
• Ketamine Injection— Resolved
• Procainamide Injection— Resolved
• Spectinomycin Injection— No Longer Available
• Trientine Capsules— Resolved

References

1. Bristol-Myers Squibb (personal communication). November 6, 2007.
2. Teva Pharmaceuticals, (personal communication). November 6, 2007.
3. King Pharmaceuticals, Dear Prescriber Letter (written communication). November 2, 2007.
4. Procanbid [product information]. Bristol, TN: Monarch Pharmaceuticals, 2002.
5. Procainamide. In: McEvoy GK, ed. AHFS 2007 Drug Information. Bethesda, MD: American Society of Health-System Pharmacists; 2007:1588-1593.
6. Sotalol. In: McEvoy GK, ed. AHFS 2007 Drug Information. Bethesda, MD: American Society of Health-System Pharmacists; 2007:1869-1875.
7. Acebutolol. In: McEvoy GK, ed. AHFS 2007 Drug Information. Bethesda, MD: American Society of Health-System Pharmacists; 2007:1813-1818.
8. Class Ia Antiarrhythmics. In: McEvoy GK, ed. AHFS 2007 Drug Information. Bethesda, MD: American Society of Health-System Pharmacists; 2007:1584-1598.
9. Class Ib Antiarrhythmics. In: McEvoy GK, ed. AHFS 2007 Drug Information. Bethesda, MD: American Society of Health-System Pharmacists; 2007:1599-1604.
10. Class Ic Antiarrhythmics. In: McEvoy GK, ed. AHFS 2007 Drug Information. Bethesda, MD: American Society of Health-System Pharmacists; 2007:1604-1623.
11. Class III Antiarrhythmics. In: McEvoy GK, ed. AHFS 2007 Drug Information. Bethesda, MD: American Society of Health-System Pharmacists; 2007:1623-1640.
12. Antiarrhythmic Agents. In: Novak KK, ed. Drug Facts and Comparisons - Updated Monthly. St. Louis, MO: Wolters Kluwer Health; 2007:405-437d.
13. Vassallo P, Trohman RG. Prescribing amiodarone: an evidence based review of clinical indications. JAMA 2007; 298:1312-1322.
14. Shah SA, Kluger J, White CM. Monotherapy versus combination therapy with class III antiarrhythmic agents to attenuate transmural dispersion of repolarization: a potential risk factor for torsade de pointes. Pharmacotherapy 2007;27(9):1297-305.

Updated

Created November 7, 2007 by Erin R. Fox, Pharm.D., and Jane Chandramouli, Pharm.D., Drug Information Specialists. Copyright 2007, Drug Information Service, University of Utah, Salt Lake City, UT.

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