Central Nervous System Agents
Manufacturer: Eli Lilly and Company
Drug Approval Classification: Supplemental New Drug Application (Approval Date: 12/15/03)
New Warnings: FDA and Lilly modified the label for Permax (pergolide mesylate) 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. The new warnings are stated as follows:
Falling Asleep During Activities of Daily Living Patients treated with Permax have reported falling asleep while engaged in activities of daily living, including the operation of motor vehicles, which sometimes resulted in accidents. Although many of these patients reported somnolence while on Permax, some perceived that they had no warning signs such as excessive drowsiness, and believed that they were alert immediately prior to the event. Some of these events had been reported as late as 1 year after the initiation of treatment.
Somnolence is a common occurrence in patients receiving Permax. Many clinical experts believe that falling asleep while engaged in activities of daily living always occurs in a setting of preexisting somnolence, although patients may not give such a history. For this reason, prescribers should continually reassess patients for drowsiness or sleepiness, especially since some of the events occur well after the start of treatment. Prescribers should also be aware that patients may not acknowledge drowsiness or sleepiness until directly questioned about drowsiness or sleepiness during specific activities.
Before initiating treatment with Permax, patients should be advised of the potential to develop drowsiness and specifically asked about factors that may increase the risk with Permax such as concomitant sedating medications or the presence of sleep disorders. If a patient develops significant daytime sleepiness or episodes of falling asleep during activities that require participation (eg, conversations, eating, etc), Permax should ordinarily be discontinued. If a decision is made to continue Permax, patients should be advised to not drive and to avoid other potentially dangerous activities.
While dose reduction may reduce the degree of somnolence, there is insufficient information to establish that dose reduction will eliminate episodes of falling asleep while engaged in activities of daily living.
Permax (pergolide mesylate) Labeling
Permax (pergolide mesylate)
Medscape Pharmacists. 2004;5(1) © 2004 Medscape
Cite this: January 2004 - Medscape - Jan 26, 2004.