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Dear Health Care Professional:

This letter is to advise you of the possibility of patients falling asleep while performing daily activities, including operation of motor vehicles, while receiving treatment with MIRAPEX (pramipexole dihydrochloride tablets), a dopamine agonist, indicated for the treatment of the signs and symptoms of idiopathic Parkinson's Disease. While somnolence is a common occurrence in patients receiving MIRAPEX and many clinical experts believe that falling asleep while engaged in activities of daily living only occurs in the context of pre-existing somnolence, many patients who have fallen asleep have perceived no warning. Health Care Professionals should be alerted to the potentially serious risks associated with the events and should carefully evaluate their patients for the presence of somnolence, and should have a discussion with them.

To communicate this important safety information, the following has been added to labeling:

Falling Asleep During Activities of Daily Living:

Patients treated with MIRAPEX have reported falling asleep while engaged in activities of daily living, including the operation of motor vehicles which sometimes resulted in accidents. Although many of these patients reported somnolence while on MIRAPEX, some perceived that they had no warning signs such as excessive drowsiness, and believed that they were alert immediately prior to the event. Some of these events have been reported as late as one year after the initiation of treatment.

Somnolence is a common occurrence in patients receiving MIRAPEX at doses above 1.5 mg/day. Many clinical experts believe that falling asleep while engaged in activities of daily living always occurs in a setting of pre-existing somnolence, although patients may not give such a history. For this reason, prescribers should continually reassess patients for drowsiness or sleepiness, especially since some of the events occur well after the start of treatment. Prescribers should also be aware that patients may not acknowledge drowsiness or sleepiness until directly questioned about drowsiness or sleepiness during specific activities.

Before initiating treatment with MIRAPEX, patients should be advised of the potential to develop drowsiness and specifically asked about factors that may increase the risk with MIRAPEX such as concomitant sedating medications, the presence of sleep disorders, and concomitant medications that increase MIRAPEX plasma levels (e.g., cimetidine – see PRECAUTIONS, Drug Interactions). If a patient develops significant daytime sleepiness or falling asleep during activities that require active participation (e.g., conversations, eating, etc.), MIRAPEX should ordinarily be discontinued. If a decision is made to continue MIRAPEX, patients should be advised to not drive and to avoid other potentially dangerous activities. While dose reduction clearly reduces the degree of somnolence, there is insufficient information to establish that dose reduction will eliminate episodes of falling asleep while engaged in activities of daily living.

The PRECAUTIONS-Information for Patients section statement on somnolence has been replaced with the following:

Changes consistent with the added warning have also been made to the ADVERSE EVENTS section and the DOSAGE AND ADMINISTRATION section.

Our primary concern is the safety and well–being of patients who use MIRAPEX. If you become aware of any case(s) of the event described above in patients treated with MIRAPEX or other dopaminergic agents, please report the event promptly. You may contact P&U regarding events associated with MIRAPEX at 1-800-253-8600 or the FDA MedWatch program by phone at 1-800-FDA-1088, by fax at 1-800-FDA-0178, or by mail to MedWatch, HF-2, FDA, 5600 Fishers Lane, Rockville, MD 20857.

Sincerely,

MIRAPEX is copromoted by Pharmacia & Upjohn and Boehringer Ingelheim Pharmaceutical, Inc.

Enclosure: Complete prescribing information for MIRAPEX Tablets