Calling for the FDA to Revise the Eight Sinemet a Day Rule
You can find out more about NPF's National Medical Director, Dr. Michael S. Okun, by also visiting the NPF Center of Excellence, University of Florida Center for Movement Disorders & Neurorestoration.
One of the most exciting aspects of medicine and of medical research has been the direct translation of discoveries from bench to bedside. In the 1950s, Arvid Carlsson rescued animals with Parkinsonian symptoms by utilizing a new chemical compound called L-Dopa. Carlsson’s work led to his Nobel Prize in 2000. In the late 1960’s, his observations were translated into humans by George Cotzias, and the drug L-Dopa instantly became one of the most remarkable treatments for a human neurological disease ever introduced to the public. In 1988, the combination drug known as Sinemet (carbidopa/levodopa) was approved by the FDA, and millions of Parkinson’s disease patients have enormously benefited.
In the early years, the expertise in the best use of Sinemet had not been fully realized or even understood. Paralleling the discovery and use of this drug was a blossoming specialty of neurology, now referred to as movement disorders. Movement disorders neurologists embraced Sinemet, and used it to refine the treatment of their patients. They became skilled at tailoring therapy to improve individual and highly specific symptoms. As a specialty, they made important observations and published many seminal papers.
Amazingly, many patients with this previously devastating neurodegenerative condition began surviving twenty plus years, and thus even general doctors began commonly using Sinemet.
As patients with Parkinson’s disease survived longer and longer on new Sinemet drug regimens, scientists and physicians began to better understand the titration of dosages, and the efficient management of patients. It soon became very clear to the medical field that in the right expert hands, adjustment of medication dosages and intervals was intimately tied to the short and long term success for the individual Parkinson’s disease sufferer. It also became clear that the drug Sinemet was safe, and tolerable in nearly every case.
It may therefore come as shock for the public at large to learn that the 1988 FDA recommendation not to exceed eight tablets of Sinemet a day has to date never been revised. The original document is so antiquated that most Parkinson’s disease patients and families may find the information contained within it somewhat laughable. The document recommends taking one Sinemet tablet three times a day initially, and ultimately it recommends not to exceed two tablets four times a day. The document also states that a significant proportion of infant rats of both sexes are expected to die at a dose of 800 mg/kg. Modern Parkinson’s disease patients and their physicians understand that the management of the individual patient must be carefully tailored. The brain’s dopamine supply in Parkinson’s disease is slowly depleted and, in order to correct the deficiency, multiple doses of Sinemet administered as frequently as one and two hours apart may be necessary to restore quality of life, and to facilitate the basic integration of the Parkinson’s disease patient back into society.
Unfortunately, patients and families are not laughing at the 1988 FDA recommendations, as Medicare and insurance providers have been denying prescriptions for Sinemet and for generic carbidopa/levodopa when they exceed eight tablets a day. I think it is safe to say that it is time for the FDA to revise the eight Sinemet a day rule, and to allow patients and families to realize the full benefits of Arvid Carlsson’s remarkable discovery.
FDA Document on Sinemet Usage
Read this: Medications for Motor Symptoms
Print this checklist: Medications and You: When to Begin Medications
Posted: 10/29/2010 1:02:13 PM by
Browse current and archived What's Hot in PD? articles, the National Parkinson Foundation's monthly blog for people with Parkinson's written by our National Medical Director, Dr. Michael S. Okun.
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