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.
In this month’s What’s Hot in PD? column, I will review a few of the most important medication-related issues.
First, there can be negative effects from inactive drug ingredients, especially from the color dyes often used in pill manufacturing. There have been serious hypersensitivity reactions reported from common pill dyes. A patient recently reported on the NPF Ask the Doctor forum that he had swelling of the face, lips and mouth shortly after switching from a blue Sinemet CR 25/100 to a yellow generic formulation. We also know of patients who have reported rashes when making similar switches. It turns out that, though rare, the yellow dye commonly present in the generic form of Sinemet (carbidopa/levodopa) can be responsible for these types of side effects. Contact your doctor if you suspect you have a pill color allergy. Be aware that yellow dye allergies may occur more commonly in patients who are also allergic to aspirin. The treatment for the allergy is simply to have your doctor change you to a blue pill formulation. Some patients also benefit from avoiding yellow dyes in their diet.
Second, in 2010-2011 there was a national shortage of Sinemet. This occurred as the brand was transitioned from Merck and Company, Inc. to Mylan Pharmaceuticals, Inc. The transition resulted in a worrisome and short-term drug shortage. When generic formulations became available, multiple complaints were reported to the NPF Helpline. These complaints ranged from weaker efficacy of the generic, worsening of motor fluctuations, dyskinesia, allergy and skin rash. When switching to a generic form, patients should keep in mind that there may be as much as a 20% difference in treatment effect. However, a generic may sometimes be desired, especially in PD patients who experience dyskinesia from tiny medication dosages (some people have referred to these cases as “brittle” PD). One should remember that FDA approval of a brand name drug requires demonstration of its pharmacokinetics, efficacy, safety and tolerability in both a healthy population and also in the PD population. In contrast, approval of a generic drug only requires demonstrating its bioequivalence in the blood, but not its clinical treatment effect in PD.
And a final and important issue that has surfaced recently has been the “eight Sinemet limit.” Pharmacies and insurance companies have been citing the language in the original FDA approval of Sinemet, and denying prescription requests for PD patients requesting more than 8 tablets a day. This issue was the subject of NPF’s November 2010 What’s Hot in PD? column, Calling for the FDA to Revise the Eight Sinemet a Day Rule. The advent of electronic medical records has been compounding this difficult issue for patients, as automatic limits are now being set by nationalized computer systems. Once limits are in computer systems, they can be challenging for individual patients to change. If your insurance carrier or pharmacy blocks filling of your Sinemet prescription purely based on number of daily pills, we suggest you contact your doctor, send an appeal letter and also contact the NPF Helpline at 1-800-4PD-INFO (1-800-473-4636), as we are here to assist you. The Helpline will provide important information for your appeal, including the recent publication on this topic in the journal Movement Disorders.
Go CL, Rosales RL, Schmidt P, Lyons KE, Pahwa R, Okun MS. Generic versus branded pharmacotherapy in Parkinson's disease: does it matter? A review. Parkinsonism Relat Disord. 2011 Jun;17(5):308-12. Epub 2011 Mar 1. Review.
Okun MS. Parkinson's disease patients cannot get their dopamine replacement: The 8-sinemet limit. Mov Disord. 2011 Dec 9. doi: 10.1002/mds.24038. [Epub ahead
Posted: 2/1/2012 2:10:08 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.
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