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Important Safety Information Regarding the Antiparkinson Drug PERMAX® (pergolide mesylate): Sudden Onset of Sleep- Shire BioChem Inc.
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This is duplicated text of a letter from Shire BioChem Inc.
Contact the company for a copy of any references, attachments or enclosures.
Health Canada Endorsed Important Safety Information on PERMAX® (pergolide mesylate)
January 2004
Subject: Important Safety Information Regarding the Antiparkinson Drug Permax® (pergolide mesylate): Sudden Onset of Sleep
Dear Health Care Professional,
Shire BioChem Inc., in association with Health Canada, would like to inform you of important safety information pertaining to Permax® (pergolide mesylate), a dopamine agonist, indicated for the treatment of the signs and symptoms of early and advanced idiopathic Parkinson's disease. As reported previously for other dopaminergic agents indicated in the treatment of Parkinson's disease1, this safety information advises of the possibility of patients suddenly falling asleep while performing daily activities, including driving a car, while receiving treatment with Permax (pergolide mesylate). Somnolence is a known potential side effect of Permax (pergolide mesylate), but the occurrence of sudden onset of sleep during daily activities has been rarely reported.
Permax (pergolide mesylate) has been available in Canada since 1991.
This safety information advises that patients receiving treatment with Permax (pergolide mesylate) have reported suddenly falling asleep while engaged in activities of daily living, including the driving of a car, which has sometimes resulted in accidents. Although some of the patients reported somnolence while on Permax (pergolide mesylate), others perceived that they had no warning signs, such as excessive drowsiness, and believed that they were alert immediately prior to the event.
Physicians should alert patients of the reported cases of sudden onset of sleep, bearing in mind that these events are NOT limited to initiation of therapy. Patients should also be advised that sudden onset of sleep has occurred without warning signs and should be specifically asked about factors that may increase the risk with Permax (pergolide mesylate) such as concomitant medications or the presence of sleep disorders. If drowsiness or sudden onset of sleep should occur, patients should immediately contact their physician.
Given the reported cases of somnolence and sudden onset of sleep (not necessarily preceded by somnolence), physicians should caution patients about the risk of operating hazardous machinery, including driving motor vehicles, while taking Permax (pergolide mesylate). Episodes of falling asleep while engaged in activities of daily living have also been reported in patients taking other dopaminergic agents, therefore, symptoms may not be alleviated by substituting these products.
Presently, the precise cause of this event is unknown. It is known that many Parkinson's disease patients experience alterations in sleep architecture, which resulted in excessive daytime sleepiness or spontaneous dozing and that dopaminergic agents can also induce sleepiness. There is insufficient information to determine whether this event is associated specifically with Permax (pergolide mesylate), all dopaminergic agents, or Parkinson's disease itself.
The identification, characterization, and management of drug-related adverse events are dependent on the active participation of Healthcare Professionals in adverse event reporting programs. Healthcare Professionals are asked to report any suspected adverse events in patients receiving Permax (pergolide mesylate) directly to Shire BioChem at the following address:
Pharmacovigilance department
C/O Sophie Bérubé
Shire BioChem Inc.
275 Armand-Frappier Blvd
Laval, Quebec
H7V 4A7
Fax: 450-978-7717
Any suspected adverse reaction can also be reported to:
Canadian Adverse Drug Reaction Monitoring Program (CADRMP)
Marketed Health Products Directorate
HEALTH CANADA
Address Locator: 0701C
OTTAWA, Ontario, K1A 0K9
Tel: (613) 957-0337 or Fax: (613) 957-0335
To report an Adverse Reaction, consumers and health professionals may call toll free:
Tel: 866 234-2345
Fax: 866 678-6789
cadrmp@hc-sc.gc.ca
For other inquiries: please refer to contact information
The AR Reporting Form and the AR Guidelines can be found on the Health Canada web site or in The Canadian Compendium of Pharmaceuticals and Specialties.
Your professional commitment in this regard has an important role in protecting the well-being of your patients by contributing to early signal detection and informed drug use.
Should you have any questions or require additional information regarding the use of Permax (pergolide mesylate), please contact Shire BioChem Medical Information Department at 1-800-268-2772.
Sincerely,
original signed by
Bonnie Cockhill
Director, Scientific Affairs
® Permax is a registered trademark of ELI LILLY & Co. used under license by Shire BioChem Inc.
Reference
1 Frucht S, et al. Falling asleep at the wheel: Motor vehicle mishaps in persons taking promipexole and ropinirole. Neurology 1999; 52: 1908-1910.
