Black Box Warning

The prolonged administration of procainamide often leads to the development of a positive antinuclear antibody (ANA) test, with or without symptoms of a lupus erythematosus-like syndrome. If a positive ANA titer develops, the benefits versus risks of continued therapy should be assessed. Because procainamide can cause serious blood dyscrasias, particularly agranulocytosis, neutropenia, thrombocytopenia, and bone marrow depression (which may be fatal), complete blood counts including white-cell, differential, and platelet counts should be performed at weekly intervals for the first three months of therapy and periodically thereafter. Antiarrhythmic agents, including procainamide, have not been shown to enhance survival in patients with ventricular arrhythmias, and their use should be reserved for patients with life-threatening ventricular arrhythmias.

What this means:A black box warning is the FDA's strongest required safety notice. It signals a serious or life-threatening risk. Patients should review this with their prescriber before starting, continuing, or switching Procainamide.

Other warnings & precautions

Antiarrhythmic drugs have not been shown to improve survival in patients with ventricular arrhythmias, and procainamide should be reserved for life-threatening arrhythmias because of its proarrhythmic potential.
Do not use in complete heart block, second- or third-degree AV block without a functioning pacemaker, or in torsades de pointes.
Contraindicated in patients with systemic lupus erythematosus and in those with known hypersensitivity to procaine or related ester anesthetics.
Avoid in myasthenia gravis, where procaine-like activity may worsen muscle weakness.
Discontinue if the QRS widens by more than 50% from baseline, marked QT prolongation occurs, or significant hypotension develops.
Correct hypokalemia and hypomagnesemia before and during therapy, as electrolyte disturbances increase the risk of torsades de pointes.
Reduce the dose in renal and hepatic impairment and in the elderly because of accumulation of procainamide and NAPA.
Periodic complete blood counts are recommended during the first three months and whenever symptoms suggest blood dyscrasia, given the risk of agranulocytosis.

Other warnings & precautions

Antiarrhythmic drugs have not been shown to improve survival in patients with ventricular arrhythmias, and procainamide should be reserved for life-threatening arrhythmias because of its proarrhythmic potential.

Do not use in complete heart block, second- or third-degree AV block without a functioning pacemaker, or in torsades de pointes.

Contraindicated in patients with systemic lupus erythematosus and in those with known hypersensitivity to procaine or related ester anesthetics.

Avoid in myasthenia gravis, where procaine-like activity may worsen muscle weakness.

Discontinue if the QRS widens by more than 50% from baseline, marked QT prolongation occurs, or significant hypotension develops.

Correct hypokalemia and hypomagnesemia before and during therapy, as electrolyte disturbances increase the risk of torsades de pointes.

Reduce the dose in renal and hepatic impairment and in the elderly because of accumulation of procainamide and NAPA.

Periodic complete blood counts are recommended during the first three months and whenever symptoms suggest blood dyscrasia, given the risk of agranulocytosis.

Procainamide Black Box Warning

Black Box Warning

Other warnings & precautions

Procainamide Black Box Warning

Black Box Warning

Other warnings & precautions