The following news item has been released in Canada. At the same time, the news item emphasizes:
Patients are strongly advised not to change the dose or
discontinue treatment with ReQuip without the recommendation
of their doctor.
Anti-Parkinson Drug, Requip (Ropinirole),
Can Cause Patients To Fall Asleep Without
Warning
OAKVILLE, ON -- February 14, 2000 -- Following consultation
with Health Canada, pharmaceutical manufacturer SmithKline
Beecham Pharma is advising health care professionals, patients
and caregivers of important new safety information which
indicates that ReQuip (ropinirole), a prescription medicine used
in the treatment of the signs and symptoms of Parkinson's
disease, may cause patients to suddenly fall asleep while
performing various daily activities, including driving a car.
Sixty cases of sudden onset of sleep have been reported to date,
world-wide. Of these, 10 cases originated in Canada. There have
been two fatal car accidents reported in France. ReQuip has been
available in Canada since August of 1997.
Patients should be advised that sudden sleep has occurred
without warning signs. If drowsiness or sudden sleep should
occur, patients should immediately contact their physician.
Patients are strongly advised not to change the dose or
discontinue treatment with ReQuip without the recommendation
of their doctor.
Until further information is available on the management of this
unpredictable and serious adverse event, patients who are
taking ReQuip are warned not to drive or engage in other
activities where impaired alertness could put themselves and
others at risk of serious injury or death (e.g., operating
machines).
Presently, the precise cause of this adverse event is unknown.
What is known is that many patients with Parkinson's disease
experience changes in their sleep patterns, which results in
excessive daytime sleepiness or spontaneous dozing and that
some anti-parkinson drugs can also induce sleepiness.
There is insufficient information to determine whether this
adverse event is associated specifically with ReQuip, some other
anti-parkinson drugs, or Parkinson's disease itself. SmithKline
Beecham is currently working with Health Canada to fully
research the potential causes of the sudden onset of sleep.
SmithKline Beecham Pharma is also issuing a letter, to
prescribing physicians and pharmacists which reports this new
safety information.
