Dear list members,
This was a message from the WE MOVE mailling list. This possible
side effect has been reported on before - but I think it's interesting to
read the "Dear Health Care Professional" Letter. Has anyone received this
warning from their neuro?
Linda
--------- Forwarded message ----------
From: WE MOVE <[log in to unmask]>
To: <[log in to unmask]>
Date: Fri, 1 Oct 1999 18:03:06 -0500
Subject: New Precautions for Mirapex
Message-ID: <[log in to unmask]>
The package insert for Mirapex (pramipexole) will carry a new precaution
statement concerning the potential for falling asleep during daily
activities. The labeling change follows a report of eight PD patients
taking pramipexole and one taking ropinirole who fell asleep while
driving, five of whom did not perceive any sleepiness or drowsiness
before
hand. This report was originally presented as a poster at the American
Academy of Neurology's 1999 Annual Meeting (covered by E-Move in
http://www.wemove.org/emove/article.asp?ID=59), and published as a Brief
Communication in Neurology
(http://www.ncbi.nlm.nih.gov/htbin-post/Entrez/query?uid=10371546&form=6&
d
b=m&Dopt=b).
The "Dear Health Care Professional" letter sent to physicians by
Pharmacia
& Upjohn states in part:
"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."
The new Precautions information reads in part:
"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).
Copyright 1998 WE MOVE
Editor: Richard Robinson ([log in to unmask])
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