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FDA Warning: No dietary supplements approved to treat concussions or other brain injury.
The Food and Drug Administration (FDA) has issued a warning that there are no approved dietary supplements to treat a concussions or other types of brain injury.
Can a Dietary Supplement Treat a Concussion? No!
The concussion supplement warning published by the FDA is published in full below:
Exploiting the public's rising concern about concussions, some companies are offering untested, unproven and possibly dangerous products that claim to prevent, treat or cure concussions and other traumatic brain injuries (TBIs).
The Food and Drug Administration (FDA) is monitoring the marketplace and taking enforcement actions where appropriate, issuing warning letters to firms—the usual first step for dealing with claims that products labeled as dietary supplements are intended for use in the cure, mitigation, treatment, or prevention of disease. The agency is also warning consumers to avoid purported dietary supplements marketed with claims to prevent, treat, or cure concussions and other TBIs because the claims are not backed with scientific evidence that the products are safe or effective for such purposes. These products are sold on the Internet and at various retail outlets, and marketed to consumers using social media, including Facebook and Twitter.
One common but misleading claim: Using a particular dietary supplement promotes faster healing after a concussion or other TBI.
Even if a particular supplement contains no harmful ingredients, that claim alone can be dangerous, says Gary Coody, FDA's National Health Fraud Coordinator.
"We're very concerned that false assurances of faster recovery will convince athletes of all ages, coaches and even parents that someone suffering from a concussion is ready to resume activities before they are really ready," says Coody. "Also, watch for claims that these products can prevent or lessen the severity of concussions or TBIs."
A concussion is a brain injury caused by a blow to the head, or by a violent shaking of the head and upper body. Concussions and other TBIs are serious medical conditions that require proper diagnosis, treatment, and monitoring by a health care professional. The long-term impact of concussions on professional athletes and children who play contact sports has recently been the subject of highly publicized discussions.
A growing body of scientific evidence indicates that if concussion victims resume strenuous activities—such as football, soccer or hockey—too soon, they risk a greater chance of having a subsequent concussion. Moreover, repeat concussions can have a cumulative effect on the brain, with devastating consequences that can include brain swelling, permanent brain damage, long-term disability and death.
“There is simply no scientific evidence to support the use of any dietary supplement for the prevention of concussions or the reduction of post-concussion symptoms that would allow athletes to return to play sooner,” said Charlotte Christin, acting director of FDA’s Division of Dietary Supplement Programs.
Click here for more information.
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The location of impact is not predictive of concussion outcome in football collisions
The Centers for Disease Control and Prevention estimates that annually, up to 3.8 million sport-related concussions occur in the United States.1 For adolescents and young adults, sports, such as football, account for a substantial proportion of these concussions.
There has been little research assessing the role of impact location on concussion outcome. A recent study published online, August 14, 2014 in the Journal Pediatrics, Impact Locations and Concussion Outcomes in High School Football Player-to-Player Collisions, attempts to answer this question.
The study concluded that, “among high school football players who sustained concussions due to player-to-player collisions, concussion outcomes were generally independent of impact location.”
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VA develops concussion app to assist in concussion management
The Veterans Administration has developed a new mobile app that provides information on concussion symptoms and the self-management of the common symptoms following a concussion.
The concussion app’s main goals are:
- To provide education about a concussion
- To provide a 22 question inventory about symptoms that may develop following a concussion including dizziness, balance problems, headaches, memory and concentration impairments,
- To provide tools to assist individuals properly manage the symptoms of mild traumatic brain injury when they develop
- To provide resources and support for professional care and web sites with information about traumatic brain injury.
- The app can be used by anyone and is not restricted to veterans.
More information is available by clicking here
Brain Injury & Concussions, Brain Injury Latest Medical News, Brain Injury Rehabilitation, Brain Injury Veteran Issues
Post Concussion Sleep Issues-Department of Defense Issues New Recommendations
New recommendations from the U.S. Department of Defense (DOD) advise that all patients with concussion symptoms should be screened for the presence of a sleep disorder and patients. Additionally, patients should be asked if they are experiencing frequent difficulty in falling or saying asleep, excessive daytime sleepiness or usual events during sleep.
These new recommendations were released this month by DOD along with support tools to assist in the identification and treatment of sleep disturbance in persons following mild traumatic brain injury, also known as a concussion.
Sleep disorders are a frequent symptom following a concussion and must be identified and treated as soon as possible. According to many medical experts, a good sleep cycle is critical to the brain’s ability to heal and recover following a concussion.
The new Management of Sleep Disturbances following Acute Concussion/Mild TBI Recommendations suite is composed of clinical recommendations, a clinical support tool, a provider education slide deck and a patient education fact sheet. More information can be obtained by clicking here.
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Lead Off Speaker at American Association for Justice-Traumatic Brain Injury Litigation Group
On Sunday, July 27th, I will be the lead off speakier at the annual conference of the American Association for Justice, Traumatic Brain Injury Litigation Group’s annual program to be held this year in Baltimore, Maryland.
My topic this year is entitled, From Concussion to the Classroom and Playing Field. I will explore the many legal issues in recently enacted concussion management legislation, public health issues and additional steps that must be taken to protect our nation’s youth from the epidemic of traumatic brain injury in all sports.
Recent evidence points to over 250 million of our nation’s youth sustain some type of a traumatic brain injury each year while participating in athletic competition all athletic training. Brain injury in sports is a public health crisis that must be approached from many different areas including education, prevention, return to play guidelines and legal liability when a preventable brain injury takes place.
The legal conference is a part of the four day conference sponsored each year by the nation’s largest trial lawyer association, the American Association for Justice. The conference each year is attended by over 2,000 attorneys from across the nation. The conference provides educational skills to attorneys on how to more effectively represent their clients following a personal injury.
The traumatic brain injury litigation group is comprised of attorneys who have a special interest in the area of traumatic brain injury litigation. I have been honored to have been a chair of this group and continue to serve on the group’s executive board.
Brain Injury & Concussions, Brain Injury and Sports
World Cup Soccer Hasn't Heard-When in Doubt, Keep Them Out!
My comments on the cavalier conduct of World Cup soccer in allowing players with head injuries to prematurely return to play before proper clearance were published last evening by the New York Daily News. Click here to read the article.
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Even Phineas Gage would be denied benefits under the NFL class action settlement if received his injury while playing football!
Illustrative of the inadequacy of the NFL class action settlement are the injuries sustained by Phineas Gage and how he would fair under this agreement.
Perhaps the most famous traumatic brain injury patient in the history of medicine was Phineas Gage. In 1848, Gage was a 25-year-old railway construction foreman, working with explosive powder and a packing rod. A spark caused an explosion that propelled the three-foot long pointed rod through his head. It penetrated his skull at the top, passed through his brain, and exited through his temple. Before the accident Gage was a quiet, mild-mannered man; after his injuries he became an obscene, obstinate, self-absorbed man. His personality and behavioral problems persisted until his death in 1861.
Had Phineas Gage sustained these injuries while playing professional football, he would not be entitled to any benefit under the proposed settlement agreement.
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NFL settlement fails to provide redress for majority of players
It is unfortunate that the U.S. District Court Brody granted preliminary approval to the proposed settlement of the NFL class action lawsuit without first holding a hearing to examine significant issues affecting the ability of players to obtain the compensation they deserve.
I am hopeful that hearing scheduled for November 19th, will explore the obstacles, roadblocks, and hurdles that players in all classes of injury must overcome before receiving compensation under this settlement proposal. The majority of players suffering with brain injuries are not embraced within the settlement and will receive no compensation.
The revised settlement is flawed in many respects. The proposal neither recognizes nor compensates the majority of players who suffer the long-term consequences of brain trauma, but merely carves out certain, small and discrete groups. The majority of players who have physical, cognitive, emotional, and behavioral impairments will remain uncompensated under this settlement.
Though this settlement proposal purports to generously provide financial stability for the futures of thousands of players who suffer from traumatic brain injury and its consequences, closer scrutiny reveals something entirely different. An examination of the terms and conditions of the settlement reveals a design to systematically exclude players from participation and reduce payments to the small group who meet the arbitrary criteria. It imposes unfair and illogical restrictions on the categories of compensable injuries and requires players to have participated in NFL play for excessively long periods, implicitly denying that a player can sustain a life-altering concussion after only a short NFL career. The plan is replete with complex, arbitrary, and overlapping omissions in its unwieldy and overly intricate criteria, which are then further reduced by offset for liens.
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Traumatic Brain Injury Course at George Washington University Law School Featured in NY Times Article
This semester I had the privilege of teaching the first ever course on traumatic brain injury (TBI) law in a law school at The George Washington University Law School, Washington, D.C.
The course reviewed the complicated issues that confront the legal profession in the framework of the civil justice system following traumatic brain injury, introducing students to the broad and wide-ranging legal implications of TBI in children and adults.
With the recent law suit and its potential settlement, new research on the long-term repercussions to returning service members after seemingly minor brain trauma, and constant stories in the news of children suffering traumatic brain injury playing sports, there is a burgeoning interest in concussions and brain injury. In a variety of legal settings, the brain is being placed on trial with increasing frequency, encompassing multitude of civil issues that were reviewed in this thirteen week course.
For the past thirteen weeks we have delved into the legal problems that confront attorneys representing victims of brain trauma, both in and out of the courtroom. The course looks at brain injury from the practical view point of attorneys charged with the responsibility of assisting individuals suffering with a brain injury in a variety of situations such as contested court proceedings, educational issues, insurance benefits, and obtaining government benefits and services. We also explore legislative initiatives on concussion management; issues of liability following sports incurred brain injury; and evidentiary issues pertaining to the admissibility of expert testimony in a traumatic brain injury case.
Earlier this week, I was honored that the New York Times published an article describing the course and our mission to educate the next generation of attorneys. Concussion Cases Inspire New Course at George Washington’s Law School.
I will again be teaching this seminar at George Washington University Law School this fall.
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Tomorrow is Brain Injury Awareness Day on Capitol Hill-2014
Tomorrow is Brain Injury Awareness Day on Capital Hill. I intend to partipate in the day's events to advocate on behalf of individuals with brain injury and their families and look forward to you joining me.
Here is an updated schedule of the day's events:
Brain Injury Awareness Day 2014
10:00 AM - 2:00 PM
Brain Injury Awareness Fair
First Floor Foyer of the Rayburn House Office Building
Brain Injury Assoc. of America
American Association of Hyperbaric Awareness
Brain Trauma Foundation
Centers for Disease Control
Kessler Foundation/Kessler Institute
VA Office of Research and Development
VISTA Life Sciences
American Academy of Neurology
American College of Radiology
American Medical Rehabilitation Providers Association
American Music Therapy Association
American Physical Therapy Association
American Speech-Language-Hearing Association
"@" Attention Fund
Assoc. of Rehab Nurses
Bob Woodruff Foundation
Brain Injury Alliance of Washington
Brain Injury Services, Inc.
Center for Neuroscience and Regenerative Medicine
Disability Rights New Jersey
Disability Services Center, JBS International
International Brain Research Foundation
JFK Rehabilitation Center
MedStar National Rehab Hospital
Model Systems Knowledge Translation Center
Mount Sinai Brain Injury Research Center
National Disability Rights Network
Neuro Kinetics, Inc.
New Jersey Brain Injury Association
Rusk Rehab at NYU Lagone Medical Center
Team River Runner
2:30 PM - 4:00 PM
Briefing: "Returning to Work: Making Headway After Brain Injury"
John O'Neill, Ph.D., CRC
Director, Employment and Disability Research
Dr. Grant Baldwin
Director of the Division of Unintentional Injury Prevention
Centers for Disease Control
Dr. Jim Kelly
National Intrepid Center for Excellence
Sgt. John Irwin
Veteran of Operation Enduring Freedom Afghanistan
United States Army
Warrior to Work
Wounded Warrior Project
Daniel Chamberlain, JD
Brain Injury Association of America
U.S. Capitol Visitor Center Meeting Room South
5:00 PM - 7:00 PM
Reception Celebrating Brain Injury Awareness Month
The Gold Room 2168, Rayburn House Office Building