Before prescribing QUINAGLUTE® as prophylaxis against recurrence of atrial fibrillation, the physician should inform the patient of the risks and benefits to be expected (see CLINICAL PHARMACOLOGY). Discussion should include the facts

• that the goal of therapy will be a reduction (probably not to zero) in the frequency of episodes of atrial fibrillation; and
• that reduced frequency of fibrillatory episodes may be expected, if achieved, to bring symptomatic benefit; but
• that no data are available to show that reduced frequency of fibrillatory episodes will reduce the risks of irreversible harm through stroke or death; and in fact
• that such data as are available suggest that treatment with QUINAGLUTE® is likely to increase the patient's risk of death.

To confirm whether this is the most current prescribing information available on Quinaglute®, or to obtain the most current prescribing information, please call Berlex Laboratories at 1-888-BERLEX-4 (choose option #4, Product Usage Information).

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