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.
Recently the U.S. Food and Drug Administration (FDA) has been making headlines with multiple press releases and statements which cover several drugs commonly consumed by Parkinson’s disease patients. It is critical that the Parkinson’s disease patient, as well as his or her family, fully understand FDA lingo. Below is information drawn directly from the FDA’s website and from FDA press releases spanning the past decade.
A FDA Drug Recall refers to the removal of an over-the-counter or prescription drug from the market. The recall is usually prompted by unexpected safety issues not identified during clinical trials. Once a drug is approved, unexpected adverse effects occurring outside of a clinical trial may be reported to the FDA through a program referred to as MedWatch. A recall may occur “on a firm's own initiative, by FDA request, or by FDA order under statutory authority.”
The FDA specifically defines and classifies drug recalls on its website:
“Class I recall: a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
Class II recall: a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Class III recall: a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
Market withdrawal: occurs when a product has a minor violation that would not be subject to FDA legal action. The firm removes the product from the market or corrects the violation. For example, a product removed from the market due to tampering, without evidence of manufacturing or distribution problems, would be a market withdrawal.
Medical device safety alert: issued in situations where a medical device may present an unreasonable risk of substantial harm. In some case, these situations also are considered recalls.”
A few drugs important to patients with Parkinson’s disease have been recently recalled and are summarized below:
Cisapride (Propulsid) was a drug used to help gastrointestinal emptying issues, but was removed from the market for heart related safety issues.
Tolcapone (Tasmar) was a drug used to treat on-off fluctuations in Parkinson’s disease patients, and to extend the longevity of each sinemet dose. It was recalled due to several cases of fatal liver toxicity. It was however, reintroduced onto the market after the FDA mandated a black box warning. The black box warning is named for the black border surrounding an inserted text warning. The warning communicates a potentially serious or life threatening event that could be possibly encountered by using the drug. Tolcapone now requires liver function tests, and is considered by most experts to be safe, as long as there is adequate drug monitoring.
Pergolide (Permax) was a drug designed to stimulate dopamine receptors (a dopamine agonist), and it was removed from the market because it was associated with damage to heart valves.
Rotigotine (Neupro patch) was a dopamine agonist patch that was reviewed by the FDA, and ultimately recalled. The FDA will allow it back in the U.S. market after reformulation to prevent a drug crystallization problem.
Recently the FDA announced it was reviewing the drug Stalevo (a combination of carbidopa/levodopa and entacapone) for a potential increase in cardiac risk. Stalevo was originally FDA approved in 2003, and 154,000 patients currently take the drug. Seven heart attacks and one heart related death occurred in a recent Stalevo trial (STRIDE-PD). The issues seemed to be exclusively isolated to the study group consuming Stalevo, and not to the study group ingesting plain carbidopa/levodopa tablets. It is important to point out that there have been over a dozen trials of Stalevo reported without this cardiac issue. When the available cardiac data was analyzed without the STRIDE-PD study data, the cardiovascular risk seemed to disappear.
Interestingly, the STRIDE-PD trial also was recently placed under FDA review for potential prostate cancer risk (3.7% in the Stalevo group versus 0.9% in the carbidopa/levodopa group). Again, like with cardiovascular risk, it was not completely clear (from the small amount of data available) that this issue was actually Stalevo related.
Patients should be aware that the data currently being reviewed by the FDA (on Stalevo) was not collected with the purpose to assess cardiovascular or prostate cancer risk. Stalevo remains on the market pending this FDA review.
In conclusion, it is important for Parkinson’s disease patients and their family members to be vigilant in following up drug related press releases, especially those concerning drugs under review or FDA recall. Patients should ask their doctors to discuss the risk-benefit ratio of any drug under current FDA review, and also they should inquire about potential alternative management strategies. In cases where a drug may remain available overseas after removal from the U.S. market (e.g. rotigotine), a risk benefit ratio and a management strategy discussion should be sought. Drug recalls, withdrawals, reviews, and safety alerts are an important reality for Parkinson’s disease patients and family members. It is critical for patients to be ready on short notice to contact their treating physician, and to be flexible about formulating a reasonable plan. Parkinson’s disease patients must maintain balance in their Parkinson’s drug management, and also balance in their daily lives.
Posted: 9/2/2010 7:16:13 AM 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.
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