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
In the letter Pharmacia & Upjohn and
Boehringer Ingelheim Pharmaceuticals has stated that their primary concern is the safety
and wellbeing 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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