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.
Tips for Parkinson’s Disease Patients Switching from Sinemet or Madopar to Rytary (IPX066)
More Evidence Linking Gut Bacteria to Parkinson’s Disease: A Guide for Patients
Two New Therapies for Parkinson’s Disease Patients to get Excited About: Vaccines and Monoclonal Antibodies
The Importance of a Monitoring Strategy When Prescribing Dopamine Agonists: Lessons from the National Parkinson Foundation Data
Is Midlife Migraine Related to Late Life Parkinson’s Disease?
Deep Brain Stimulation for Parkinson’s Disease: NPF Congratulates Mahlon DeLong and Alim-Louis Benabid and Looks to a Bright Future in Human Neural-Network Modulation
Everything You Need to Know About Medical Marijuana and Parkinson’s Disease
The End for Levodopa Phobia: New Study Shows Sinemet is a Safe Initial Therapy for Treatment of Parkinson's Disease
Is light therapy a potential treatment modality in Parkinson’s disease?
How does the most common genetic cause of Parkinson’s Disease (LRRK2) cause Parkinson’s disease and could it be used to help develop a better therapy?
An Update on DAT Scanning for Parkinson’s Disease Diagnosis
Could Northera (Droxidopa) Be an Alternative Treatment for Low Blood Pressure and Passing Out Symptoms?
The Dream of a Pill Free Existence and the Continuous Dopaminergic Pump for the Treatment of Parkinson's Disease
Should I take Inosine to Raise my Uric Acid Levels and Treat my Parkinson’s Disease?
Could Fungus and Mold be an Important Contributor to Parkinson’s Disease?
Pimavanserin and the Hope for a Better Drug for Hallucinations and Psychosis in Parkinson’s Disease
Halting of the Creatine Study
The Importance of Identifying and Treating Caregiver Strain
Putting Parkinson’s Disease Information into the Palm of Your Hand: Parkinson’s Enters the Smartphon
What Parkinson’s Disease Patients Need to Know about H. Pylori Gastrointestinal Infections
A2A Receptor Antagonists and Parkinson’s Disease Treatment
Another Setback for Trophic Factor Treatment in Parkinson's Disease
IPX066 and What Patients Really Want in New Carbidopa/Levodopa (Sinemet) Formulations
The Weather Forecast for Parkinson’s Disease Calls for Worldwide Economic Storm
Defeating the Barriers to Implementing Exercise Regimens in Parkinson’s Disease Patients
When should you start medication therapy for Parkinson’s disease?
Neurologist Care Reduces Hospitalizations in Parkinson's Disease
A Victory in Court for Parkinson's Disease Patients who Require Ongoing Rehabilitative Therapies
Given the recent FDA announcement about Mirapex (pramipexole), should I be worried about dopamine agonists?
What about the new Parkinson’s Disease Vaccine? What should I know?
Caffeine as a Potential Treatment for Parkinson’s Disease
Time to Consider GPi DBS for Parkinson’s Disease: A Shift in the Practice of Patient Selection for DBS
A New Treatment for Parkinson’s Disease-Related Constipation
Too Many Pills: Improving Delivery Systems for Parkinson’s Disease Drugs
Measuring Quality and Assessing Depression in Parkinson's Disease
Watch out for Unexpected Obstacles if You Use a Cueing Strategy to Break Freezing of Gait in Parkinson’s Disease
Pill Color, Generic Medications and Insurance Issues: Important Medication-Related Tips for the Parkinson’s Disease Patient
Are Blood Tests for Parkinson’s Disease on the Horizon?
Placing Stem Cells in Animal Models of Parkinson’s Disease: Another Important Step
Important News for the Parkinson’s Disease Community: More Evidence that Sinemet and Madopar are Not Toxic and do Not Accelerate Disease Progression
The Case for All Parkinson’s Disease Patients to be Co-managed by a Primary Care-Neurologist Team
Scientists say Research on Brain Proteins Involved in Parkinson’s Disease is “Shaping” Up
Who Actually Takes Care of Most of the Parkinson’s Patients Worldwide: The Need for Education and the Parkinson’s Toolkit
If you are Dizzy or Passing Out, it could be Your Parkinson’s Disease or Parkinson’s Disease Medications
How Will Group Visits for Parkinson’s Disease Fit into the Future of Parkinson’s Disease Care?
Why Patients Should be Wary of Chelation Therapy for Parkinson’s Disease
Opening the Door to Gene Therapy in Parkinson’s Disease: The Need for Refinement of the Technology and Approach
Does it Matter if I Can’t Get Brand Sinemet?
Should I get a DaTscan or PET scan to confirm my diagnosis of Parkinson’s disease?
A Critical Reappraisal of the Worst Drugs in Parkinson’s Disease
Environmental Risks for PD: Manganese, Welding, Mining, and Parkinsonism
Calling for the FDA to Revise the Eight Sinemet a Day Rule
Dry Cleaning Solvents and Potential Environmental Risks for Developing Parkinson’s Disease
Maintaining the Balance: Why Parkinson’s Disease Patients Need to Understand Drug Recalls, Withdrawals, and Safety Alerts
Shining a Light on Parkinson’s Disease: Optogenetics Has a Bright Future in Research
Poor Medication Management of Parkinson's Disease During Hospital Admissions: Patients and Families Can Improve Their Hospital-Based Management
Why Are Patches and Continuous Release Technology a Big Deal to Parkinson's?
Is the PD SURG Trial Another Surge Forward for DBS Therapy?
Cycling in PD in Those Who Can’t Walk: Is it Possible?
New iPS Stem Cells for PD: What Does it Mean?
Time for Comprehensive Care Networks for PD
Is Parkinson's Disease a Prion Disease?
Parkinson's Disease Linked to Gaucher's Disease
Brain Cells Keep Time Stamps: Implications for Parkinson's Disease Therapies
Is it Safe to Have an MRI with a DBS in Place?
Take Care of Your Bones as They Are Affected in Parkinson's Disease (Even in Men)
Is it Time to Start Paying Attention to Pain Symptoms in Parkinson's Disease Patients?
Glutathione Fails to Demonstrate Significant Improvement in PD Symptoms
Keeping an Eye on Trials Important to the Parkinson's Disease Patient
Increased Risk of Melanoma in Parkinson's Disease
Finally a DBS Expert Consensus Statement Aimed at Their True Customers: The Patients
Pesticides and Environmental Exposure in Parkinson's disease: Should We Stay Away From the Stink Truck?
Is Exercise Effective Treatment and Protection Against PD?
Why are Transplant Trials Struggling to Succeed in the Treatment of PD?
Are Monoamine Oxidase Inhibitors Disease Modifying or Neuroprotective in PD?
Update on Gene Therapy for Parkinson's Disease