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.

Selected References:

http://www.fda.gov
http://www.fda.gov/Safety/Recalls/default.htm

Posted: 9/2/2010 7:16:13 AM by Cathy Whitlock


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. 

October 2014
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September 2014
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August 2014
Everything You Need to Know About Medical Marijuana and Parkinson’s Disease

July 2014
The End for Levodopa Phobia: New Study Shows Sinemet is a Safe Initial Therapy for Treatment of Parkinson's Disease

June 2014
Is light therapy a potential treatment modality in Parkinson’s disease?

May 2014
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?

April 2014
An Update on DAT Scanning for Parkinson’s Disease Diagnosis

March 2014
Could Northera (Droxidopa) Be an Alternative Treatment for Low Blood Pressure and Passing Out Symptoms?

February 2014
The Dream of a Pill Free Existence and the Continuous Dopaminergic Pump for the Treatment of Parkinson's Disease

January 2014
Should I take Inosine to Raise my Uric Acid Levels and Treat my Parkinson’s Disease?

December 2013
Could Fungus and Mold be an Important Contributor to Parkinson’s Disease?

November 2013
Pimavanserin and the Hope for a Better Drug for Hallucinations and Psychosis in Parkinson’s Disease

October 2013
Halting of the Creatine Study

September 2013
The Importance of Identifying and Treating Caregiver Strain

August 2013
Putting Parkinson’s Disease Information into the Palm of Your Hand: Parkinson’s Enters the Smartphon

July 2013
What Parkinson’s Disease Patients Need to Know about H. Pylori Gastrointestinal Infections

June 2013
A2A Receptor Antagonists and Parkinson’s Disease Treatment

May 2013
Another Setback for Trophic Factor Treatment in Parkinson's Disease

April 2013
IPX066 and What Patients Really Want in New Carbidopa/Levodopa (Sinemet) Formulations

March 2013
The Weather Forecast for Parkinson’s Disease Calls for Worldwide Economic Storm

February 2013
Defeating the Barriers to Implementing Exercise Regimens in Parkinson’s Disease Patients

January 2013
When should you start medication therapy for Parkinson’s disease?

December 2012
Neurologist Care Reduces Hospitalizations in Parkinson's Disease

November 2012
A Victory in Court for Parkinson's Disease Patients who Require Ongoing Rehabilitative Therapies

October 2012
Given the recent FDA announcement about Mirapex (pramipexole), should I be worried about dopamine agonists?

September 2012
What about the new Parkinson’s Disease Vaccine? What should I know?

August 2012
Caffeine as a Potential Treatment for Parkinson’s Disease

July 2012
Time to Consider GPi DBS for Parkinson’s Disease: A Shift in the Practice of Patient Selection for DBS

June 2012
A New Treatment for Parkinson’s Disease-Related Constipation

May 2012
Too Many Pills: Improving Delivery Systems for Parkinson’s Disease Drugs

April 2012
Measuring Quality and Assessing Depression in Parkinson's Disease

March 2012
Watch out for Unexpected Obstacles if You Use a Cueing Strategy to Break Freezing of Gait in Parkinson’s Disease

February 2012
Pill Color, Generic Medications and Insurance Issues: Important Medication-Related Tips for the Parkinson’s Disease Patient

January 2012
Are Blood Tests for Parkinson’s Disease on the Horizon?

December 2011
Placing Stem Cells in Animal Models of Parkinson’s Disease: Another Important Step

November 2011
Important News for the Parkinson’s Disease Community: More Evidence that Sinemet and Madopar are Not Toxic and do Not Accelerate Disease Progression

October 2011
The Case for All Parkinson’s Disease Patients to be Co-managed by a Primary Care-Neurologist Team

September 2011
Scientists say Research on Brain Proteins Involved in Parkinson’s Disease is “Shaping” Up

August 2011
Who Actually Takes Care of Most of the Parkinson’s Patients Worldwide: The Need for Education and the Parkinson’s Toolkit

July 2011
If you are Dizzy or Passing Out, it could be Your Parkinson’s Disease or Parkinson’s Disease Medications

June 2011
How Will Group Visits for Parkinson’s Disease Fit into the Future of Parkinson’s Disease Care?

May 2011
Why Patients Should be Wary of Chelation Therapy for Parkinson’s Disease

April 2011
Opening the Door to Gene Therapy in Parkinson’s Disease: The Need for Refinement of the Technology and Approach

March 2011
Does it Matter if I Can’t Get Brand Sinemet?

February 2011
Should I get a DaTscan or PET scan to confirm my diagnosis of Parkinson’s disease?

January 2011
A Critical Reappraisal of the Worst Drugs in Parkinson’s Disease

December 2010
Environmental Risks for PD: Manganese, Welding, Mining, and Parkinsonism

November 2010
Calling for the FDA to Revise the Eight Sinemet a Day Rule

October 2010
Dry Cleaning Solvents and Potential Environmental Risks for Developing Parkinson’s Disease

September 2010
Maintaining the Balance: Why Parkinson’s Disease Patients Need to Understand Drug Recalls, Withdrawals, and Safety Alerts

August 2010
Shining a Light on Parkinson’s Disease: Optogenetics Has a Bright Future in Research

July 2010
Poor Medication Management of Parkinson's Disease During Hospital Admissions: Patients and Families Can Improve Their Hospital-Based Management

June 2010
Why Are Patches and Continuous Release Technology a Big Deal to Parkinson's?

May 2010
Is the PD SURG Trial Another Surge Forward for DBS Therapy?

April 2010
Cycling in PD in Those Who Can’t Walk: Is it Possible?

March 2010
New iPS Stem Cells for PD: What Does it Mean?

February 2010
Time for Comprehensive Care Networks for PD

January 2010
Is Parkinson's Disease a Prion Disease?

December 2009
Parkinson's Disease Linked to Gaucher's Disease

November 2009
Brain Cells Keep Time Stamps: Implications for Parkinson's Disease Therapies

October 2009
Is it Safe to Have an MRI with a DBS in Place?

September 2009
Take Care of Your Bones as They Are Affected in Parkinson's Disease (Even in Men)

August 2009
Is it Time to Start Paying Attention to Pain Symptoms in Parkinson's Disease Patients?

July 2009
Glutathione Fails to Demonstrate Significant Improvement in PD Symptoms

June 2009
Keeping an Eye on Trials Important to the Parkinson's Disease Patient

May 2009
Increased Risk of Melanoma in Parkinson's Disease

April 2009
Finally a DBS Expert Consensus Statement Aimed at Their True Customers: The Patients

March 2009
Pesticides and Environmental Exposure in Parkinson's disease: Should We Stay Away From the Stink Truck?

February 2009
Is Exercise Effective Treatment and Protection Against PD?

January 2009
Why are Transplant Trials Struggling to Succeed in the Treatment of PD?

December 2008
Are Monoamine Oxidase Inhibitors Disease Modifying or Neuroprotective in PD?

November 2008
Update on Gene Therapy for Parkinson's Disease

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Each month, we will feature a new column by NPF's National Medical Director, Dr. Michael Okun, on the latest developments in Parkinson's disease research. Read the latest "What's Hot in PD?" below.

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