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U.S. Department of Health and Human Services

Safety

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Permax (pergolide mesylate) Dec 2003

Audience: Neurological and other healthcare professionals

FDA and Lilly modified the WARNINGS and PRECAUTIONS sections to inform healthcare professionals of the possibility of patients falling asleep while performing daily activities, including operation of motor vehicles, while receiving treatment with Permax, a dopamine agonist, indicated as adjunctive treatment to levodopa/carbidopa in the management of the signs and symptoms of Parkinson's disease. Many patients who have fallen asleep have perceived no warning of somnolence. Healthcare professionals should be alerted to the potentially serious risks associated with these events and should carefully evaluate their patients for the presence of somnolence

[December 15, 2003 - Letter - Eli Lilly]
[October 2003 - Label - - Eli Lilly]

Previous MedWatch alerts:
[February 2003 - Letter - Lilly]