On 17 Dec 2000, at 17:53, Robert A. Fink, M. D. wrote:
> From: Dick Swindler
> <[log in to unmask]> Subject: Mirapex - Dr. Fink To:
> [log in to unmask]
>
> > Bob -
> >
> > I'm a bit unclear as to how you intend your caution about Mirapex to
> > be read.
> > Is it your position that no one should try Mirapex because of
> > possible sleep
> > attacks, or are you suggesting that it should be tried with caution? I
> > don't know if there are any studies suggestion that if one hasn't
> > experienced a sleep attack after X number of weeks or months on the
> > drug, then one isn't likely to experience them at all. It would be
> > interesting to know.
> >
> > After two-plus years of Dick's taking Mirapex with extremely positive
> > results and no problems, ever, with sleepiness or sleep attacks, it
> > seems to me that we can feel comfortable that the problem isn't going
> > to arise.
> >
> > Margie
>
> I don't use Mirapex in my patients. If I prescribed it for a patient, I
> would instruct them not to drive a vehicle or engage in other activity
> where a sudden loss of consciousness would be dangerous (climbing on
> ladders, etc.). I know of no published work as to whether there is a
> "time limit" after which you don't have to worry about the blackouts,
> and that is why I have suggested that the doctor who prescribed the drug
> (I presume a specialist qualified to use it) be asked these questions.
>
> Best,
>
> Bob
>
>
> **********************************************
>
Hi Bob,
The package insert says...
Drug Updates | New
Warnings
pramipexole dihydrochloride / Mirapex
Date issued: October 1999
Pharmaceutical company:
Pharmacia & Upjohn Co.
www.pnu.com/home.asp
NEW WARNING
Pharmacia & Upjohn Company has revised the package labeling of
pramipexole dihydrochloride (Mirapex) to include a precaution to
patients about the risk of falling asleep without warning while
performing activities of daily living. In some cases, no excessive
drowsiness was experienced before falling asleep.
The manufacturer recommends that health care providers continually
reassess patients for drowsiness or sleepiness because somnolent
events may occur as late as 1 year after treatment has been initiated.
While performing reassessments, health care providers should directly
question patients about drowsiness or sleepiness experienced during
specific activities, so that an accurate history can be obtained.
The package labeling states that the drug should be discontinued if a
patient experiences significant daytime sleepiness or episodes of falling
asleep during daily activities that require active participation (such as
eating or talking). If the drug is not discontinued, the patient should be
advised to avoid driving or other potentially hazardous activities. While
dosage reduction may decrease the degree of somnolence, there is no
evidence to suggest that reduction of dosage will eliminate episodes of
falling asleep.
http://www.edruginfo.com/duw_pramipexoledihydrochloride.htm
Best regards ......... murray
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