One very disappointing recent turn of events has been that Parkinson's disease patients have been denied their carbidopa/levodopa, Madopar, or Sinemet. Most of the denials stem from an old FDA approval letter that stated over 800mg of dopamine is toxic to the human. This information is false, though it has not stopped pharmacies, insurance companies, and online medical record systems from denying patients their medications.
If this happens to you can contact the 18004PDHELP line at the National Parkinson Foundation for advice, and you can cite the below study in your appeal letter. Usually a simple appeal letter especially with the research data is enough to reverse the decision. Get your local doctor and neurologist to write a letter and to cite the medical information. Parkinson's disease patients should never be without their medications.
BMJ Open. 2012 Dec 11;2(6). pii: e001971. doi: 10.1136/bmjopen-2012-001971. Print 2012.
Carbidopa/levodopa dose elevation and safety concerns in Parkinson's patients: a cross-sectional and cohort design.
Department of Neurology, University of Florida Center for Movement Disorders and Neurorestoration, Gainesville, Florida, USA.
Sinemet, a combination drug containing carbidopa and levodopa is considered the gold standard therapy for the treatment of Parkinson's disease (PD). When approved by the Food and Drug Administration (FDA) in 1988, a maximum daily dosage limit of 800 mg (eight tablets) of the 25/100 carbidopa/levodopa formulation was introduced. Overall, the FDA approval was a historic success; however, the pill limit has been hardcoded into many online medical record systems. This study investigates the 800 mg threshold by using a prospectively collected database of patient information.
A retrospective cohort study: (Part I) cross-sectional, (Part II) longitudinal.
SETTING AND PARTICIPANTS:
PD patients at a Movement Disorders Center in a large academic, tertiary medical setting.
An analysis was performed using carbidopa/levodopa at dosages below and above the 800 mg threshold. A secondary analysis was then performed using two consecutive clinic visits to determine the effects of crossing the 800 mg threshold. Comparisons were made on standardised scales.
There was no significant difference in motor, mood and quality-of-life scores in patients consuming below and above the 800 mg carbidopa/levodopa threshold, though a mild worsening in dyskinesia duration was noted without worsening in dyskinesia pain and disability. In PD patients who crossed the 800 mg threshold between two consecutive clinic visits, a significant improvement in depressive symptoms and quality-of-life measures was demonstrated, and in these patients there was no worsening of motor fluctuations or dyskinesia.
The data suggest that PD patients have the potential for enhanced clinical benefits when eclipsing the 800 mg carbidopa/levodopa threshold. Many patients will likely need to eclipse the 800 mg threshold and pharmacies and insurance companies should be aware of the requirements that may extend beyond approval limits.