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Potentially Dangerous Side Effect of New Parkinson's Drugs Identified
ST. PAUL, MN -- New Parkinson's drugs may trigger potentially dangerous sleep attacks, according to a report in the June issue of Neurology, the scientific journal of the American Academy of Neurology.
Eight Parkinson's patients were in car accidents due to sudden sleep attacks while driving. In four patients sleep attacks also occurred during business meetings and phone calls. All the patients were taking one of the newer medications, which improve parkinsonian symptoms, pramipexole or ropinirole. Discontinuing the medications eliminated the sleep attacks.
Sleep attacks cause patients to unknowingly fall asleep. Patients describe attacks as a sudden, irresistible and overwhelming feeling of sleepiness.
"Suddenly falling asleep can be harmless if a patient is watching TV or reading a book," said neurologist and study author Steven Frucht, MD, of the Columbia-Presbyterian Medical Center in New York, NY. "However, if a patient is driving an automobile, this side effect is a serious safety issue."
Frucht and colleagues noticed by chance that several of their Parkinson's patients had been in car accidents. "Looking closer at this coincidence, we discovered that all the patients had suddenly fallen asleep at the wheel and all were taking pramipexole," said Frucht.
The eight patients experiencing sleep attacks had normal mental skills, excellent driving records and no history of sleep problems. At the time of their accidents, patients were taking pramipexole an average of seven months.
Following the accidents, six patients stopped taking pramipexole and two reduced their doses. None of the patients experienced further sleep attacks. One patient took ropinirole, then experienced the same side effect while driving and stopped using the medication.
Pramipexole and ropinirole are dopamine agonists that are used to treat motor symptoms of early and advanced Parkinson's disease. Both drugs were approved by the Food and Drug Administration (FDA) for Parkinson's treatment in 1997.
Medications classified as dopamine agonists can cause drowsiness in some people. In clinical trials, drowsiness affected 27 percent of early Parkinson's patients treated with pramipexole and 13 percent of those treated with ropinirole. "We are aware that these drugs may cause drowsiness, but sleep attacks were not previously reported," said Frucht.
"Pramipexole and ropinirole remain effective treatments for patients with Parkinson's disease," said Frucht. "I still use these medications with my patients, but now I warn them about sleep attacks. In the future warning labels on these medications should be altered to alert patients about the possibility of sleep attacks."
Parkinson's disease is a slowly progressive, neurodegenerative disease that affects more than 500,000 people in the United States.
The American Academy of Neurology, an association of more than 15,000 neurologists and neuroscience professionals, is dedicated to improving patient care through education and research.
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