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FDA Approves Mirapex ER for Early Parkinson’s Disease

Posted Feb 24 2010 5:19am

The Food and Drug Administration has approved the use of a new weapon in the arsenal to be used against early Parkinson’s disease.

Boehringer Ingelheim Pharmaceuticals, Inc., today announced that the U.S. Food and Drug Administration (FDA) has approved Mirapex ER® (pramipexole dihydrochloride) extended-release tablets, a new once-daily treatment option for the signs and symptoms of early idiopathic Parkinson’s disease (PD). MIRAPEX ER is not indicated in advanced PD. Parkinson’s disease is a chronic, slowly progressive and potentially debilitating neurological condition affecting nearly one million people in the U.S., with one person newly diagnosed every nine minutes.

This is great news for folks in the very early stages of this disease, especially those who are not used to taking a regimen of pills on a regular schedule.

When I was first diagnosed in 2000, I was prescribed Mirapex.  I switched to Sinemet when the Mirapex resulted in my falling asleep at inopportune moments… like sitting behind the wheel at a stop light.  Hence this warning:

MIRAPEX ER and MIRAPEX may cause you to fall asleep while you are doing daily activities such as driving, talking with other people, or eating. Talk to your doctor if you drink alcohol or take other medications that make you drowsy, as these can increase the chance that MIRAPEX ER or MIRAPEX will make you feel sleepy or fall asleep when you should be awake. When taking MIRAPEX ER or MIRAPEX, hallucinations (unreal visions, sounds or sensations) may occur and you may sometimes feel dizzy, nauseated, faint or sweaty when you sit up or stand quickly.

Gail used to watch my eyes when I was driving to see if they were getting that “glazed over” look that indicated I was about to nod off.

But it made me feel better, and I guess that’s what counts.

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