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September 22, 1999

FDA Posts Warning of Parkinson's Drug Causing Patients to Unexpectedly Sleep - Even While Driving

WASHINGTON, D.C. (SafetyAlerts) - The Food and Drug Administration (FDA) yesterday published a letter from Pharmacia & Upjohn and Boehringer Ingelheim Pharmaceuticals advising health care professionals and people who use the medication MIRAPEX that the drug may cause patients to fall asleep while performing daily activities.

Reports have been received of individuals unexpectedly falling asleep while performing everyday tasks including the driving of motor vehicles which sometimes resulted in accidents.  Although many of these patients reported somnolence (Feeling abnormally sleepy or drowsy) while on MIRAPEX, some perceived that they had no warning signs at all 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.

MIRAPEX (pramipexole dihydrochloride tablets) is used for the treatment of the signs and symptoms of idiopathic Parkinson's Disease. While somnolence is a common occurrence in patients receiving MIRAPEX  many patients who have fallen asleep have perceived no warning.

The FDA is alerting Health Care Professionals 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.

Patients should be alerted to the potential sedating effects associated with MIRAPEX, including somnolence and the possibility of falling asleep while engaged in activities of daily living. Since somnolence is a frequent adverse event with potentially serious consequences, patients should neither drive a car nor engage in other potentially dangerous activities until they have gained sufficient experience with MIRAPEX to gauge whether or not it affects their mental and /or motor performance adversely.

Patients should be advised that if increased somnolence or episodes of falling asleep during activities of daily living (e.g., watching television, passenger in a car, etc.) are experienced at any time during treatment, they should not drive or participate in potentially dangerous activities and should contact their physician. Because of possible additive effects caution should be advised when patients are taking other sedating medications or alcohol in combination with MIRAPEX and when taken concomitant medications that increase plasma levels of pramipexole (e.g., cimetidine).

In the letter Pharmacia & Upjohn and Boehringer Ingelheim Pharmaceuticals has stated that their primary concern is the safety and well–being of patients who use MIRAPEX. 

If healthcare professionals 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.

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