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| |  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. Related Links: ReQuip (ropinirole) and SmithKline Beecham Pharma.
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