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hi all forwarded from We Move: ----------------------------------------------------------------------- Subject: New Precautions for Mirapex Date: Fri, 1 Oct 1999 18:03:06 -0500 The package insert for Mirapex (pramipexole) will carry a new precaution statement concerning the potential for falling asleep during daily activities. The labeling change follows a report of eight PD patients taking pramipexole [Mirapex] and one taking ropinirole [Requip] who fell asleep while driving, five of whom did not perceive any sleepiness or drowsiness before hand. This report was originally presented as a poster at the American Academy of Neurology's 1999 Annual Meeting covered by E-Move, viz: <http://www.wemove.org/emove/article.asp?ID=59> and published as a Brief Communication in Neurology, viz: PMID: 10371546 <http://www.ncbi.nlm.nih.gov/PubMed/> The "Dear Health Care Professional" letter sent to physicians by Pharmacia & Upjohn states in part: "While somnolence is a common occurrence in patients receiving MIRAPEX and many clinical experts believe that falling asleep while engaged in activities of daily living only occurs in the context of pre-existing somnolence, many patients who have fallen asleep have perceived no warning. "Health Care Professionals should be alerted to the potentially serious risks associated with the events and should carefully evaluate their patients for the presence of somnolence, and should have a discussion with them." The new Precautions information reads in part: "Patients should be alerted to the potential sedating effects associated with MIRAPEX, including somnolence and the possibility of falling asleep while engaged in activities of daily living. "Since somnolence is a frequent adverse event with potentially serious consequences, patients should neither drive a car nor engage in other potentially dangerous activities until they have gained sufficient experience with MIRAPEX to gauge whether or not it affects their mental and /or motor performance adversely. "Patients should be advised that if increased somnolence or episodes of falling asleep during activities of daily living (e.g., watching television, passenger in a car, etc.) are experienced at any time during treatment, they should not drive or participate in potentially dangerous activities and should contact their physician. "Because of possible additive effects caution should be advised when patients are taking other sedating medications or alcohol in combination with MIRAPEX and when taken concomitant medications that increase plasma levels of pramipexole (e.g., cimetidine)." Copyright 1998 WE MOVE Editor: Richard Robinson ([log in to unmask]) E-MOVE archives, plus information on subscribing, are available at: <http://www.wemove.org/em_intro.html> To unsubscribe, send an e-mail to [log in to unmask], with "unsubscribe e-move" in the message body. E-MOVE is a service of WE MOVE (Worldwide Education and Awareness for Movement Disorders) 204 West 84th Street New York, NY 10024 TEL 800-437-MOV2 TEL 212-241-8567 FAX 212-987-7363 <http://www.wemove.org> ----------------------------------------------------------------------- janet paterson 52 now / 41 dx / 37 onset 613 256 8340 po box 171 almonte ontario canada K0A 1A0 a new voice: <http://www.geocities.com/SoHo/Village/6263/> <[log in to unmask]>