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Risk of "sleep attacks" with some PD medications prompts stern warning from PDF

Earlier this year, news articles reported cases in which people who were using certain Parkinson's medications experienced sudden, irresistible attacks of sleep. These cases came to light at a meeting of the American Academy of Neurology in Toronto, in a report authored by Dr. Stephen Frucht, an attending physician at Columbia University College of Physicians and Surgeons. In eight of the cases presented (and in many additional cases reported since), the incidents occurred while the patients was driving, causing accidents. In five of these cases, no further episode of sudden somnolence while driving occurred once the patient stopped taking the drugs.

The medication involved in the report were two new "dopamine agonists:" pramipexole (trade-name: miraplex) and ropinerole (trade-name: Requip).

Following news reports of this kind, PDF always endeavors to offer interpretation and guidance to PWP's and their families. We therefore present the following comments from Dr. Stanley Fahn, chief of movement disorders at Colombia University and scientific director of the Foundation.

"The reported cases of sleep attack, though rare, must be taken seriously. Driving is an activity that carries as much or greater danger to others as to the subject himself or herself, and the standards we suggest need to be commensurately higher than they would be if the the safety of the patient alone were at issue."

"Both Mirapex and Requip are useful additions to our inventory of medications that provide symptomatic relief for Parkinson's and many PWP's have found them helpful and effective. Although the drugs were previously known to have a tendency to induce somnolence in some patients, their tendency to bring upon sudden sleep attacks had not previously been recognized. Because it is impossible to ascertain in advance which patients will experience this side-effect, it is preferable that users of these medications avoid driving altogether."

For those patients who need to drive, Dr. Fahn noted new language in the package insert for Mirapex that was recently approved by the U.S. Food and Drug Administration. In particular: "Since somnolence is a frequent adverse event with potentially serious consequences, patients should neither drive a car or engage in other potential dangerous activities until they have gained sufficient experience with Mirapex to gauge whether or not it affects their mental and/or motor performance adversely." He also stressed that patients should always consult their physicians in determining the prudent and appropriate course of action for them.

SmithKline Beecham, the manufacturer of Requip, is planning to respond to the reports of sleep attacks by mailing a letter to physicians around the United States "warning of the risks associated with the sudden onset of sleep." (Pharmacia & Upjohn, which manufactures Mirapex, had circulated its own letters earlier in the year.)

"The new reports point to a need for more data, both on the longer-term experience of patients over an extended period with Miraplex and Requip, and on comparable experiences with other medications that were not part of the reports that we have received to date," Dr. Fahn said.

For a copy of Dr. Frucht's article, which was published in the June, 1999 edition of Neurology, readers may write, call, or email the Foundation.

Source Date: Feb 09 2000