MedWatch – The FDA Safety Information and Adverse Event Reporting Program
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.
Read the MedWatch 2003 safety summary, including links to the “Dear Healthcare Professional” letter and revised label, at: