Generic Version of Parkinson’s Drug Mirapex Clears FDA Hurdle
By Jim Greene
Published on February 06, 2010
Glenmark Generics, Inc., USA, has received tentative approval from the U.S. Food and Drug Administration (FDA) to market pramipexole dihydrochloride, a generic drug used to control symptoms of Parkinson's disease (PD). The name brand version is Mirapex®, sold by Boehringer Ingelheim Pharmaceuticals, Inc.
Pramipexole dihydrochloride is a dopamine agonist, used to reduce involuntary muscle movements suffered by PD and restless leg syndrome patients because their brains produce insufficient levels of natural dopamine. The hormone's function is to facilitate communications in the brain's muscle control center.
Final Approval is Strictly Business
Tentative approval means that Glenmark has demonstrated to the FDA that the product is equivalent to versions already approved and is safe for patient use. Final approval comes when patents on the name brand expire or when the maker of the name brand grants permission to market the generic.
When Glenmark releases its version of pramipexole dihydrochloride, it runs the risk of eventually joining Boehringer Ingelheim in court.
Plaintiffs in numerous product liability/personal injury lawsuits claim Mirapex® causes episodes of spontaneous sleeping. The episodes are often compared to narcolepsy, but are not related, except for the outcome. Narcolepsy has not been fully explained, but is known to be a neurological disorder, possibly inherited and triggered by a virus.
Sleeping Episodes Potentially Dangerous
The unpredictable spontaneous sleeping episodes may occur while the patient is driving or performing other tasks. Other possible side effects the FDA requires to be listed in Mirapex® label warnings include nausea, dizziness, involuntary movement, and constipation. Two seemingly contradictory side effects also listed are sleepiness and difficulty falling asleep.
If you have experienced episodes of spontaneous sleep or other side effects while taking Mirapex® or a generic version of pramipexole dihydrochloride, contact an experienced product liability/personal injury attorney. The consequences of spontaneous sleep can be very dangerous. You may be eligible for financial compensation to help you deal with medical costs, loss of income, and personal liability.
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