Drug Shortage Alert: Pfizer Announces DILANTIN® 100 mg (Extended Phenytoin Sodium Capsules, USP) Shortage
The Epilepsy Foundation has learned that Pfizer is contacting health care professionals, including pharmacists, about a shortage of DILANTIN 100 mg. According to Pfizer, this product shortage is due to a manufacturing issue and not the result of any performance or safety concerns.
The company expects a limited supply of DILANTIN 100 mg to be available through August 31, 2011 Check your prescription bottle to see if you might be affected by this shortage of Dilantin 100 mg. The Epilepsy Foundation's medical experts recommend that you contact your physician immediately if you use this product. Abrupt withdrawal of phenytoin in patients with epilepsy could lead to serious health issues. Please keep in mind that any change to your therapy should be done only at the direction of physician.
The following Dilantin formulations are still available through normal channels:
- DILANTIN INFATABS® (Phenytoin Tablets, USP) 50 mg ″
- DILANTIN-125® (Phenytoin Oral Suspension, USP) 125 mg ″
- DILANTIN® (Extended Phenytoin Sodium Capsules, USP) 30 mg
If you have any questions, please contact Pfizer Medical Information at 1-800-438-1985.
The Epilepsy Foundation will maintain close communication with Pfizer in order to keep you informed and obtain the most accurate timeline on when this shortage will be resolved.
Ortho-McNeil Recalls Two Lots of TOPOMAX® to Address "Musty Odor"
On Friday, April 14th, Ortho-McNeil Neurologics Division of Ortho-McNeil-Janssen
Pharmaceuticals, Inc., announced its volutary recall of two lots of TOPOMAX® (topiramate)
100mg tablets. These two lots were shipped between 10/19/2010 and 12/28/2010 and
distributed in the U.S. and Puerto Rico. While the recall encompasses approximately 57,000 bottles of TOPOMAX®,
the company believes there are fewer than 6,000 bottles remaining in the marketplace. The recall stems from four consumer reports of an
uncharacteristic odor thought to be caused by trace amounts of TBA (2,4,6 tribromoanisole).
TOPOMAX® (topiramate) Tablets
100mg bottles of 60 tablets
Doctors Andy Blum & Catherine Phillips
are featured speakers on Physician Focus
on HCAM local access cable television.
Epilepsy: The Seizure Disorder aired in March and can be viewed by this link.
If the link does not work paste this into your browser window: http://www.hcam.tv/series/physicianfocus/programs.shtml
Chair Brien Smith interviewed in the New York Times
Board Chair Brien Smith was interviewed in the New York Times in the nationally recognized "Well" blog. Click here to read the interview.
New Medication Alert!
Drug shortage alert: Pfizer announces DILANTIN 30 mg
(Extended Phenytoin Sodium capsules, USP) Shortage
The Epilepsy Foundation has learned that Pfizer is contacting health care professionals, including pharmacists, about a shortage of DILANTIN 30 mg. According to Pfizer, this product shortage is due to a manufacturing issue and not the result of any performance
or safety concerns. The company expects DILANTIN 30 mg to be available to patients by June 30, 2011. The DILANTIN 30 mg product is used by a limited number of people, so check your prescription bottle to see if you might be affected by this shortage. The Epilepsy Foundation's medical experts recommend that you contact your physician immediately if you use this product. Please keep in mind that any change to your therapy should be done only at the direction of your physician.
Update for Team 8 of Leominster Robotics Team
The students on the Team 8 Leominster Robotics Team (Blue Thunder) has won the Project Research and Innovative Solution for Robot Design in November and in December 2010 they won the Mechanical Design Award for Robot Design from the Agawam qualifier. Last week the team won the Innovative Solution Award for their project at the state Championship Tournament in Worcester at WPI. Congratulations to this team of hardworking and creative students! They are working on an article to be submitted to the Epilepsy USA magazine for publication some time next year.
Leominster Students Raise Epilepsy Awareness with projects and inventions to help people living with epilepsy.
A group of students in elementary and middle schools in Leominster have been working since the summer on a Robotics team. They chose to study epilepsy and the brain and to create inventions that would help people who have seizures. On October 26, 2010 these students presented their posters, research and inventions. The first invention presented was a sleep mask that is designed to prevent Sudden Unexplained Death related to Epilepsy (SUDEP).
The research these students did was comprehensive.
One invention featured a model of an emergency shut off device for the shower to prevent drowning.
The Foundation appreciates the creativity, intelligence and hard work of this group of students.
Hollywood Movie Premiere Highlights
National Epilepsy Awareness Month
, November 11, 2010 /PRNewswire/ — The Epilepsy Foundation’s National Epilepsy Awareness Month gets a boost from Paramount Pictures and JJ Abrams’ Bad Robot Productions with a red carpet affair and after party for Morning Glory, starring Harrison Ford, Diane Keaton, and Rachel McAdams.
Greg Grunberg and Epilepsy Foundation
Get Stars to Talk About It!
CLICK HERE to read the full article and check out videos and pictures from Greg Grundberg Movie Premiere Highlights!
Boston Globe Editorial on Epilepsy
November 5, 2010
RESEARCHERS HAVE made progress in understanding Parkinson's disease and Alzheimer's, but less so in the case of another common neurological disease, epilepsy. This is a source of great anguish to the 3 million patients and their families coping with seizure disorders, which can range from temporary attacks to lifelong-and often life-ending bouts with the disease. Advocates for epilepsy sufferers have removed some of the stigma from a disease once seen as demonic possession. Now, the challenge is to get the federal government and private groups to fund more research into its causes.Click hereto read more.
Epilepsy Education & Networking Conference Video Link is Live!
The March 27, 2010 Epilepsy Education & Networking Conference at Dartmouth-Hitchcock Medical Center is now available for viewing. The morning presentations are available on the Dartmouth Hitchcock Website including presentations by Dr. Richard Morse, Dr. Vijay Thadani, Dr. Barbara Jobst and Dr. Greg Holmes. Many thanks to the marketing department at DHMC for making this available.
Local Pediatric Epilepsy Resource Site
Epilepsy Online is an extensive webpage created to gather resources targeting children and families dealing with epilepsy. The page, www.chadkids.org/epilepsyonline, includes an extensive and downloadable Resource Guide. The site is dedicated to ensuring that families have access to the best and most reliable resources for caring for a child with epilepsy or seizures.
Families everywhere know it's expensive to care for a child with a chronic illness and those costs extend well beyond prescription refills and doctor visits. The isolation can be overwhelming; information, education and community support can be in short supply. Epilepsy Online can help connect patients, families and health care providers with local, national and online resources.
Epilepsy Online was developed through Project Access with the Hood Center for Children and Families and CHaD, Children's Hospital at Dartmouth.
National Resources: There is a nationwide network of communities working together for those living with epilepsy. These resources offer an opportunity to share with others what it's like living with epilepsy, giving you the chance to make connections with advocacy and family partnerships and organizations, summer camps and regional epilepsy foundations.
Online Resources: With links to secure chat rooms, international sites, educational resources and interactive sites, these resources provide not only information about pediatric epilepsy but also a safe place to interact with others who are in the same situation as you and your family.
Medication Assistance: Highlights the best programs for financial support and prescription information.
Podcasts and Videos: Experts from DHMC and Project Access offer advice an dinformation for parents and medical professionals about the intricacies of epilepsy and caring for a child with a seizure disorder. New topics are posted regularly. Join the Dartmouth-Hitchcock channel on YouTube.com for more epilepsy videos.
CDC Releases Report on Effects of Swine Flu in Children
Atlanta, GA. Sept. 4, 2009--The Centers for Disease Control (CDC) released a study today detailing the effects the swine flu (H1N1) has had on children in the United States. The study results were released in the Sept. 4, 2009, issue of CDC's publication, Morbidity and Mortality Weekly Report.
As of August 8, 2009, 477 deaths have been associated with 2009 pandemic influenza A (H1N1) virus infection in the United States, including 36 children younger than 18 years. Based on studies from previous influenza outbreaks, children aged younger than 5 years or with certain chronic medical conditions are at increased risk for complications and death from influenza. Sixty-seven percent of children who died had at least one chronic high-risk medical condition. Neurodevelopmental conditions, such as developmental delay, epilepsy, and cerebral palsy, were the most frequently noted chronic medical conditions, reported in over 90 percent of children with a chronic medical condition. A number of children also had bacterial infections, including most childrren who were older than 5 years and did not have high-risk medical conditions. This finding suggests that bacteria, in combination with H1N1 influenza, can cause severe disease in children who may be otherwise healthy.
The CDC advises: Any child, even previously healthy children and especially those with chronic medical conditions, can have severe illness or even death from 2009 Pandemic influenza A (H1N1). All children aged 6 months and older should receive 2009 pandemic influenza A (H1N1) vaccine when it becomes available, and children with high-risk medical conditions should immediately consult with a health care provider if they develop an illness consistent with influenza.
For more information on the swine flu visit:
To read the full report visit:
Epilepsy on the cover of Newsweek!
The cover article of Newsweek declares: "Why we must find a cure!"
The health section of the April 20, 2009 issue of Newsweek has several articles about epilepsy. The cover article is an overview of the unrecognized impact of epilepsy, the second article features personal stories and the third article is by Susan Axelrod (founding member of CURE, Citizens United for Research in Epilepsy).
Makers of epilepsy drugs face new warnings on suicide
03:14 PM CDT on Wednesday, June 4, 2008
Makers of epilepsy drugs including Pfizer Inc. and Johnson & Johnson may be required by U.S. regulators to warn patients their products double the chances of suicidal thoughts or behavior.
Outside advisers to the Food and Drug Administration plan to meet July 10 to discuss how to communicate the risks first announced by the agency in a Jan. 31 notice to health-care providers, agency spokeswoman Sandy Walsh said today in a phone interview. Further review of data from studies of 11 epilepsy drugs confirmed what the FDA believes is a risk shared by all members of this class of medicines, she said.
The agency may release its final analysis as early as today and is discussing with drugmakers how best to notify doctors and patients, Walsh said. The agency faces reluctance from drug companies that say the review is flawed because it groups data from different types of medicines, the Wall Street Journal reported today.
"We want health-care professionals to have the most up-to- date drug safety information," Walsh said. "We've been working with the manufacturers of these drugs to figure out the best way to convey the risk to the public."
The FDA can't comment on its discussions with drugmakers by law. The agency usually follows the recommendations of its advisory panels, though it isn't required to do so.
Products included in the review are Pfizer's Neurontin and Lyrica, J&J's Topamax, GlaxoSmithKline Plc's Lamictal, Meda AB's Felbatol, UCB SA's Keppra, Novartis AG's Trileptal, Cephalon Inc.'s Gabitril, Abbott Laboratories' Depakote, Eisai Co.'s Zonegran, and carbamazepine, sold by several drugmakers.
"GlaxoSmithKline has told the FDA we are ready to expand the current label for Lamictal with information from our own analysis of data, but the FDA has requested that we wait for class labeling language based on the agency's analysis of 11 different epilepsy drugs," said Glaxo spokeswoman Mary Anne Rhyne, in a telephone interview.
-taken from www.dallasnew.com
Genetic Cause for Childhood Absence Epilepsy Identified
Researchers have identified the mutated gene that causes Childhood Absence Epilepsy (CAE).
by Kristina Chew, PhD on June 2nd, 2008
The seizures of childhood absence epilepsy (CAE) are usually staring spells during which the child is not aware or responsive. The child’s eyes may roll up briefly. Each spell lasts about 10 seconds and ends abruptly. The child often is not even aware that anything has happened. These episodes can occur 1 to 50 times per day, often during exercise. Tonic-clonic (grand mal) seizures, with or without fever, may occur for a while before absence seizures develop and may occur from time to time thereafter. [Epilepsy.com]
The Childhood Absence Epilepsy Family Study also notes that CAE is also known as “Petit Mal” or epilepsy with “staring spells.” CAE is an inherited disorder and accounts for 10-12 percent of cases of childhood epilepsy.
The new study that points to a genetic cause for CAE appears in the May 29th online edition of the American Journal of Human Genetics. The study’s authors are from the David Geffen School of Medicine at UCLA and the Epilepsy Genetics/Genomics Laboratory, Epilepsy Center at the VA-Greater Los Angeles Healthcare System in West Los Angeles.
UCLA/VA research scientist Dr. Miyabi Tanaka studied the DNA of 48 patients with CAE and discovered that four patients had a genetic mutation occurring in a receptor called GABAR which binds to a neurotransmitter of the brain called GABA that inhibits the excitation of nerve cells in child and adult brains. When this regulation is lost or reduced, seizures develop.
“We identified this genetic mutation in eight percent of study patients with CAE, which is significant,” said Richard W. Olsen, Ph.D., study author and professor, Department of Molecular and Medical Pharmacology, David Geffen School of Medicine at UCLA.
Scientists also found that the genetic mutation was caused by an “alternative signal peptide called exon 1a, which is richly expressed in the fetus and developing brain, but as the child matures and becomes an adult, the expression of exon 1a is reduced”—-and this is why CAE “disappears” in adolescence and in adults.
We have wondered about the possibility of my son having seizures like the “absence seizures” noted above. Charlie’s pediatric neurologist specializes in epilepsy and seizures and (based on our descriptions of Charlie’s behavior) does not think he is having these types of seizures. Since my son’s language is very limited, we can never be 100% certain about anything, though—-hence the continuing interest in the possibility of medical signs and/or tests to detect conditions; to find answers.
-story taken from http://www.autismvox.com.
AG Coakley Reaches Settlement with Express Scripts
As part of a multistate agreeement, Express Scripts is to pay $9.3 million to states and prohibited from engaging in drug switching.
May 27, 2008
BOSTON - Today, Massachusetts Attorney General Martha Coakley's Office, together with 28 other state Attorneys General, entered into a settlement with Express Scripts Inc., one of the nation's largest pharmacy benefits management (PBM) companies, resolving claims that its drug switching programs are unfair or deceptive under the Massachusetts Consumer Protection Act.
"This settlement with Express Scripts is part of our office's continued efforts to introduce transparency and fairness to the PBM industry," said Attorney General Coakley. "Through the work of the State Attorneys General, first with Medco, then Caremark and now Express Scripts, we have changed how these companies treat patients and doctors when they ask to change their prescription medications-those requests now include full information on costs savings and the reasons for the proposed switch."
As part of the Assurance of Voluntary Compliance, filed today in Suffolk Superior Court, Express Scripts has agreed to make clear and conspicuous disclosures about its business practices to its consumers, doctors and employers, including its policies on initiating any drug interchanges between one brand name drug to another brand name drug. Express Scripts also will pay $9.3 million to the States and up to $200,000 in reimbursement to patients who incurred expenses related to certain switches between cholesterol-controlling drugs called statins. Massachusetts will receive a total of more than $255,000 from this settlement, including $65,000 in costs and fees and the balance to be used to benefit low-income, disabled or elderly consumers of prescription medications, to promote lower drug costs for state residents, to educate consumers concerning the cost differences among medications.
Today's settlement asserts that Express Scripts engaged in deceptive business practices by not always acting in a manner consistent with its representations to consumers and employers about its PBM services. Specifically, Express Scripts may have overstated the cost benefits of switching to certain brand name medicines, which may have resulted in additional medical costs for consumers. Additionally, Express Scripts did not clearly disclose to their clients plans that rebates accrued from the drug switching process would be earned by Express Scripts.
The settlement generally prohibits Express Scripts from soliciting drug switches when:
" The net drug cost of the proposed drug exceeds the net drug cost of the originally prescribed drug;
" The originally prescribed drug has a generic equivalent and the proposed drug does not;
" The originally prescribed drug's patent is expected to expire within six months; or
" The patient was switched from a similar drug within the last two years.
Additionally, the settlement requires Express Scripts to:
" Inform patients and prescribers what effect a drug switch will have on a patient's co-payment;
" Inform prescribers of Express Scripts' financial incentives for certain drug switches;
" Inform prescribers of material differences in side effects or efficacy between prescribed drugs and proposed drugs;
" Reimburse patients for out-of-pocket expenses for drug switch-related health care costs and notify patients and prescribers that such reimbursement is available;
" Obtain express, verifiable authorization from the prescriber for all drug switches;
" Inform patients that they may decline a drug switch and the conditions for receiving the originally prescribed drug;
" Monitor the effects of drug switches on the health of patients;
" Adopt a certain code of ethics and professional standards;
" Refrain from making any claims of savings for a drug switch to patients or prescribers unless Express Scripts can substantiate the claim; and
" Inform prescribers that visits by Express Scripts' clinical consultants and promotional materials sent to prescribers are funded by pharmaceutical manufacturers, if that is the case.
PBMs enter into contracts with employer and governmental health plans to process prescription drug claims for drugs provided to patients enrolled in those health plans; negotiate with drug companies to obtain discounts; negotiate discounts with participating retail pharmacies to provide dispensing services; and dispense drugs to patients through PBM-owned mail order pharmacies. In the thirty years since the first PBMs appeared, their services have evolved to include complex rebate programs, pharmacy networks, and drug utilization reviews.
Today's resolution marks the third settlement that the states have entered into with pharmaceutical benefits managers. In 2004, a group of 20 of states settled with Medco Health Solutions, Inc., the world's largest pharmaceutical benefits manager. In February of this year, a group of 29 states settled with Caremark Rx, LLC, another of the world's largest pharmaceutical benefits managers.
Joining Massachusetts in today's settlement are: Arizona, Arkansas, California, Connecticut, Delaware, District of Columbia, Florida, Illinois, Iowa, Louisiana, Maryland, Michigan, Mississippi, Missouri, Montana, Nevada, New Mexico, North Carolina, Ohio, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Vermont, Virginia, and Washington.
The matter was handled by Assistant Attorney General Christopher Barry-Smith, Chief of Attorney General Coakley's Consumer Protection Division.
-Taken from AG Press Release
Kennedy upbeat day after seizure
By Noah Bierman and Brian R. Ballou Globe Staff / May 19, 2008
When Barack Obama picked up the phone to speak with Edward M. Kennedy yesterday, he expected his Senate colleague would be groggy from medication following a seizure Saturday.
But Kennedy, 76, who remains in the hospital, surprised him with his vigor and sense of humor, Obama said in a telephone interview yesterday while campaigning in Portland, Ore.
"He sounded great," Obama recounted. "He sounded like the Ted Kennedy we know and love. He joked a little bit about [how] this happens when you get an old politician going out there on the road."Kennedy spent yesterday watching baseball and movies from his hospital room, as doctors tried to determine what caused the seizure that prompted national concern over the political icon's health.
That meant another day of anxious waiting for Kennedy's family and friends, along with a public that has closely followed the family's political and personal narrative for generations.
Kennedy's doctor at Massachusetts General Hospital has said it would be until at least today before tests would offer greater insight into the senator's health. Kennedy's inner circle would not commit to a timeline for making those results public. It is uncertain when Kennedy will be able to resume his busy political schedule.
Family members continued to stay close to Kennedy yesterday as he fielded calls from friends and fellow political leaders, including Democratic senators Charles Schumer of New York and Christopher Dodd of Connecticut, according to Kennedy spokeswoman Stephanie Cutter. Kennedy has been a key supporter of Obama's presidential campaign.
Obama said he does not want Kennedy rushing back to the campaign trail and expects the senator's wife, Victoria Reggie Kennedy, to enforce doctors' orders, once his course of care is established. "All of us believe that he probably needs to rest up," Obama said.
"Obviously, we were all very worried yesterday," Obama said.
"I had spoken to Vickie, and she had indicated that the initial prognosis was better than what may have been reported in the press."
After watching the Red Sox game yesterday, Kennedy planned to view a few rented movies to pass the time: "The Great Debaters, "Best in Show," and some old Fred Astaire movies, Cutter said.
Kennedy's wife, along with some of his children, step-children, and other relatives, stayed by his side. Members of the news media continued to stake out the hospital in hopes of learning more details about Kennedy's health.
Cutter said Kennedy had a good night sleep Saturday night, following a chaotic day that started at his family's compound at Hyannis Port.
Kennedy was flown from Cape Cod after suffering what was first feared to be a stroke, but doctors later determined to be a seizure. Seizures - short electrical disturbances in the brain - rarely cause brain damage or other long-term problems but they can be indicators of more significant health problems. Possible causes include fever, infection, stroke, a tumor, or a previous head injury.
Kennedy's personal physician, Dr. Larry Ronan, said Saturday that further tests would seek to clarify a cause and a course of treatment, but that preliminary tests have determined "he has not suffered a stroke and is not in any immediate danger."
In October, Kennedy was admitted to Mass. General for surgery to clear a neck artery that was partially blocked by plaque. Doctors said at the time that the surgery, intended to prevent a stroke, was routine and successful.
© Copyright 2008 Globe Newspaper Company.
Watch Video from Fox 25
Parents Of Child With Epilepsy Organize Walk To Help Others
May 16th, 2008
Saco - Two hundred people have pre-registered for the walk this Sunday, and more are welcome. It's being organized by Kristine and Jason Binette of Sanford, whose nine-month-old daughter, Delia, has epilepsy.
Delia had her first seizure when she was four weeks old. She has had more than eighty seizures since.
Kristine says when Delia was first diagnosed she and Jason discovered that there were no support groups or programs for people with epilepsy in Maine. They decided to change that.
It has taken a tremendous amount of work to organize the walk. But Kristine says they've had lots of help from family and friends.
She also says local businesses have stepped up to the plate. The Olive Garden in Biddeford is providing lunch after the two mile walk. Poland Spring is donating water. Riley's Bakery will bring the cookies and cupcakes. Panera Bread is donating pastries and the pizza will be from Pappa John's.
Kristine says she is overwhelmed by their generosity.
The walk is a "family" event--kids are welcome. There will be clowns from the Shrine Circus there, as well as balloons, ice cream and face painting.
The walk will raise money and awareness about epilepsy.
"I don't want Delia growing up," says Kristine, "and looking back at me and saying ok, Mom, what did you do when you found out I had epilepsy? I don't want her to hear me say I stopped, I cried and I did nothing about it. I needed her to understand that mommie did something about it. I stood up, I took a stand. I can't go into the lab and help you find a cure. But I can help raise the money to find that cure for you."
Walkers are asked to assemble at Young School in Saco for the 9am registration.
First Epilepsy Walk Held In Maine
May 19, 2008
SACO (NEWS CENTER) -- More than 200 people hit the streets of Saco Sunday morning for the first Maine Walk for Epilepsy.
Kristine and her husband, Jason, worked with the Epilepsy Foundation in Massachusetts and Rhode Island to kick off fundraising events in Maine.Sunday's two mile walk is part of a string of fundraisers to draw attention and support for families. Their nine-month-old daughter was diagnosed with epilepsy when she was four weeks old. They soon discovered there weren't any support groups here in Maine, so they decided to do something about it.
©2007 WCSH6.com/Gannett Co., Inc. All Rights Reserved.
Randomized Trial Confirms Efficacy of Ketogenic Diet
May 6, 2008
A randomized controlled trial has confirmed the efficacy of the ketogenic diet in helping control and prevent epileptic seizures in children with drug-resistant epilepsy. These are the conclusions of authors of an article published early online and in the June edition of The Lancet Neurology.
The ketogenic diet has been used widely and successfully to treat children with drug-resistant epilepsy since the 1920s. It is a diet very high in fat, low in carbohydrate, and with controlled protein. Although the exact mechanism of action is still unclear, the high fat and restricted carbohydrate content of the diet is thought to mimic the biochemical response to starvation, when ketone bodies*, rather than sugars, become the main fuel for the brain’s energy demands. While there have been many observational studies of this diet, Professor J. Helen Cross of the Institute of Child Health and Great Ormond Street Hospital for Children NHS Trust at the University College in London and colleagues have done the first randomized controlled trial to test its efficacy.
The trial assessed 145 children aged between 2 and 16 years who had at least daily seizures (or more than seven seizures per week), had failed to respond to at least to antiepileptic drugs, and had not been treated previously with the ketogenic diet. Seventy three children were put on the diet immediately while 72 were assigned to the diet after a delay of three months. The delay group acted as the control group during the three-month delay. Using the baseline figures as 100 percent, they found that the number of seizures in the diet group dropped by more than a third (62 percent of seizures recorded compared with baseline), while the control group saw their seizures rise by more than a third. Twenty-eight of the 54 children who completed the three months in the diet group had greater than 50 percent seizure reduction compared with just four of 49 children in the control group. Five children in the diet group saw a seizure reduction of above 90 percent, compared to none in the control group. The most frequent side-effects reported at three months were constipation, vomiting, lack of energy and hunger.
The authors said, “We have shown that the diet has efficacy and should be included in the management of children who have drug-resistant epilepsy. However, the diet is not without possible side-effects, which should be considered alongside the risk benefit of other treatments when planning the management of such children.” They added, “We stress this is a diet which should only be undertaken on medical advice and under medical and dietetic supervision.”
Dr. Max Wiznitzer of Rainbow Babies and Children’s Hospital in Cleveland said more information is needed about the long-term effects of the ketogenic diet, including changes in blood fat concentrations and persistent ketosis. He added, “Better identification of epilepsies that benefit from starting early on the ketogenic diet and comparisons between the choices of ketogenic diet are needed.”
*Ketone bodies are water soluable compounds that are produced as by-products when fatty acids are broken down for energy in the liver and kidneys. They are used as a source of energy in the heart and brain. In the brain, they are a vital source of energy during fasting.
Source: Adapted from a press
Kennedy Seizure linked to Brain Tumor
May 20, 2008 02:21 PM
By Globe Staff
US Senator Edward M. Kennedy, the veteran senator from Massachusetts who is the last surviving brother in the legendary Kennedy family, has been diagnosed with a malignant brain tumor, his doctors said today.
Doctors investigating the cause of a seizure that led to Kennedy's hospitalization this weekend said that preliminary results from a brain biopsy indicated the cause of the seizure was a tumor in the top left portion of his brain.
The usual course of treatment includes combinations of various forms of radiation and chemotherapy, Dr. Lee Schwamm, vice chairman of the neurology department at Massahusetts General Hospital, and Dr. Larry Ronan, Kennedy's primary care physician, said in a statement.
The doctors said decisions regarding the best course of treatment for the 76-year-old senator would be determined after further testing and analysis.
"He has had no further seizures, remains in good overall condition, and is up and walking around the hospital," the statement said. "Senator Kennedy will remain at Massachusetts General Hospital for the next couple of days according to routine protocol. He remains in good spirits and full of energy."
Kennedy's wife and children have been with him each day since he was hospitalized but have made no public statements.
The senator's wife, Victoria Reggie Kennedy, arrived today at Mass. General at 6:20 a.m., stepping out of a black sport utility vehicle and walking briskly inside. His sons -- Edward M. Kennedy Jr. and Representative Patrick Kennedy of Rhode Island -- came to visit their father at 9:45 a.m. None of the Kennedys talked to the gaggle of photographers and reporters standing watch outside.
Malignant gliomas are a type of brain cancer diagnosed in about 9,000 Americans a year and are the most common type among adults. It's a starting diagnosis: How well patients fare depends on what specific tumor type is discovered.
Average survival can range from less than a year for very advanced and aggressive types -- such as glioblastomas -- to about five years for different types that are slower-growing.
Kennedy's hospitalization Saturday triggered shock in the political world and drew an outpouring of support from around the nation. But the initial alarm subsided when friends and associates said later that day that he was talking and joking with family later that day -- and watching the Red Sox game.
The youngest of the nine children of Joseph P. Kennedy and Rose Fitzgerald Kennedy, Edward Kennedy was first elected to the Senate in 1962 to finish the final two years of his brother's term. He has been reelected to eight full terms and is now the second most senior member of the Senate.
A champion of liberal causes, he unsuccessfully ran for president in 1980, losing the Democratic nomination to President Carter.
Senate Democrats and Republicans were in their separate weekly policy lunches when word reached them of the diagnosis.
CNN reported there was stunned silence.
Senator Mitch McConnell of Kentucky, the Republican leader, said colleagues said a prayer for Kennedy and his family. "They have experienced so much tragedy in their lives," he said at a news conference.
Senator Kent Conrad, a North Dakota Democrat, predicted if anyone could overcome the illness Kennedy would. “Look what he’s been through in his life,“ Conrad said, according to CNN.Sen. Frank Lautenberg, a
Democrat from New Jersey, said “Ted Kennedy makes the Senate the place that it is and has been for so many years,” CNN reported.
Material from The Associated Press was used in this report.
Epilepsy no match for Hingham runner's resolve
By Kathleen McKenna, Globe Correspondent | April 17, 2008
For many people, running a marathon is an odyssey of sorts. For Karen Donahue of Hingham, the 26.2-mile race that she's already completed four times, and will run again on Monday, represents an odyssey she egan 23 years ago.
She was a new student at St. Michael's College in Vermont, excited about racing on the school's ski team. But five days into the fall semester, she collapsed while walking on campus. She awoke in the hospital and was told she had epilepsy.
The neurological condition produces brief disturbances in the normal electrical functions of the brain, or seizures. More than 3 million Americans have some form of epilepsy, but more than half are able to control their seizures with medication.
Donahue, who had what's referred to as "uncontrolled" epilepsy, was not so fortunate. Doctors told her she could no longer ski, bike, swim, or drive a car. "When you have epilepsy, the first thing you lose is your independence," she said.
She returned to Vermont to finish the school year, but everything had changed. She had frequent seizures, and she missed skiing and other sports.
Her college experience, she says, "was more about survival."
At the end of the year, she moved home to upstate New York, but living with her parents made her feel "coddled" in a way she could not abide. So she moved to Boston, in part because city life was easier for someone who couldn't drive.
She found an apartment, graduated from Northeastern, and married Paul Donahue at age 26. While pregnancy and parenthood pose unique challenges for epileptics, they were determined to start a family. Daughter Justine was born in 1995.
Soon after, Donahue's seizures grew worse. She was terrified that she would collapse while holding the baby. Although she had hoped to have more children, she accepted that Justine would be her only one. Then, around the time that Justine turned 1, she learned that she was pregnant again. Justine got a brother, John.
Life as an epileptic mother wasn't easy. Donahue relied on her husband to buy groceries and pick up coffee. (She was afraid to keep a coffee machine in the house, lest she knock it over during a seizure.) She hired people to drive her and the kids to appointments.
And she worried constantly that her condition might put her children in danger. "I've never given either of my children a bath," she said.
It was against Donahue's nature to have so little control over her own life. Then the longtime athlete found a way to get some of that control back, by running.
"I ran because I needed a way to get out into the world," said Donahue, who sometimes ran with friends or neighbors. "I needed the fresh air. I needed the sense of community."
She recalled how Paul would strap the kids in the car and follow her on runs, in case she had a seizure. She often did, but she kept on running. And she kept hoping she'd find a way to rid herself of seizures forever.
When her son was nearly a year old, Donahue underwent risky brain surgery. The doctors were initially optimistic, but a week later, the seizures returned.
In 2003 Donahue, who'd always dreamed of running a marathon, decided to do something positive for others with epilepsy. She got a number in the Boston Marathon and raised $25,000 for Camp Wee-Kan-Tu, a weeklong sleepover camp in Duxbury for kids with epilepsy. She finished the marathon, without a seizure, and was hired as the camp's director.
Later that year, she decided to run the New York City Marathon "just for myself," she said. This time she did have a seizure; she collapsed about 400 yards from the finish line. Someone - she never learned who - took her hand and helped her cross the finish line. When she awoke in the medical tent, she learned that even with the seizure she had finished the race in 3 hours and 45 minutes, which qualified her for the Boston race.
That accomplishment, she said, made her feel like "a real runner, not just a runner with epilepsy."
In 2004, an MRI revealed a structural abnormality near the cerebral cortex of her brain. Removing it could cure her of seizures, doctors said, but there was a chance she'd be left with a severe speech impediment.
The following year she opted for surgery, and doctors were able to remove 95 percent of the abnormality. After a long recovery, including therapy to address various motor issues, she was healed. Since then she hasn't had a seizure.
Last year, Donahue ran her first "epilepsy-free" marathon in Boston, and finished in an impressive 3 hours and 27 minutes. The very next day, she got her driver's license.
She spent the summer driving her kids, now 13 and 11, "everywhere she'd ever wanted to take them." She said she especially relishes the little things, such as ferrying the kids to friends' houses and dentist appointments.
On Monday, she aims to finish the race in 3 hours and 20 minutes.
"I've become," she says, "a very firm believer in positive thinking."
Kathleen McKenna can be reached at firstname.lastname@example.org.
Running: My Ticket to Freedom
4/17/2008 Hingham- Hingham resident Karen Donahue will be running the 112th Boston Marathon on behalf of the Epilepsy Foundation of Massachusetts and Rhode Island on April 21. She hopes to raise money to benefit many programs including Camp Wee-Kan-Tu, a camp for kids with epilepsy, a program very near and dear to her heart. Donahue ran the 107th Boston Marathon in 2003 in spite of her uncontrolled seizures and raised $25,000 for children with epilepsy.
“Running has been my ticket to freedom,” Donahue says. “It gives me the feeling of independence, the first thing you loose when you experience a seizure, the second thing you lose is your license to drive.
“The journey began 23 years ago at the age of 18 five days after I began college. I woke up in a hospital bed with a nun standing over me, I thought I had died and I was in heaven, but it was actually a Catholic hospital and I had suffered my first grand mal seizure,” she says.
For the next two decades, Donahue dealt with frequent, unpredictable seizures that were unresponsive to every medication available. She had also endured a number of surgeries, without any success and was still battling epilepsy every day. Donahue wasn’t ready to give up though and decided to give surgery another try, this time with amazing results and has been seizure free for the past 18 months. Everything has gone full circle and now five years later will be running the race again, without the fear of seizures and with her independence back. For the first time she will be crossing the finish as a runner but also as someone who can drive.
“I will never loose sight of my running, it has gotten me through many challenging years, but now that I am driving the simplest things have been life changing,” she says. “Things such as going to the market, picking a sick child up at school, going out for ice cream, or to the library or over to a friends for a play date. As my kids explain it, ‘now we are normal.’ Just recently they said, ‘Wow, this is the first time you’ve ever brought us to the dentist.’ Things people don’t look forward to, they were very excited. I realize just how lucky I am but there are so many still fighting this battle.
“Approximately 1-1/2 to 2 percent of the population has epilepsy and of that percentage 30 percent are uncontrolled as were mine. I now feel compelled to fight on behalf of others with epilepsy. Programs, awareness, education and much research are still needed,” Donahue says.
To find out more or make donations online, visit the Web site at efmri.org. Donations can be made out to EFMRI and mailed to: Epilepsy Foundation of Massachusetts and Rhode Island, attention: Karen Donahue, 540 Gallivan Blvd., Boston, MA 02124.
Story taken from the 4/17/2008 Edition of the Hingham Journal
Epilepsy Empowerment Roundtable Shines a Light on Challenges with Epilepsy
by Lisa Boylan, editor, EpilepsyUSA 4/1/2008
On the morning before the historic National Walk for Epilepsy, Epilepsy Foundation President and CEO, Eric Hargis, moderated an Epilepsy Empowerment Roundtable at the National Press Club in Washington, D.C. Joined by a panel of leading health care professionals (HCPs), patients, caregivers and celebrities in the epilepsy community, the discussion centered on challenges uncovered by a recent national survey indicating gaps in patient-physician communication, medication-related side effects and low public awareness of epilepsy. The event was co-hosted by National Walk partner Ortho-McNeil Neurologics.
Hargis introduced panel member, Greg Grunberg, star of NBC’s hit series Heroes, noting, “people with epilepsy really need a hero.” Grunberg has tirelessly lent his name recognition to raise awareness about the condition on behalf of his son, Jake, who was diagnosed with epilepsy when he was 7 years old. Other panelists included Epilepsy Foundation professional advisory board members David Labiner, M.D. of the University of Arizona, Mark Spitz, M.D., of the University of Colorado, Georgia Montouris, M.D., of Boston Medical Center, Geoff Pope, cornerback with the Super Bowl Champion New York Giants, Kelly Richards, mother of Carly, an Expressions of Courage art contest winner and epilepsy patient and Caitlin Purcell, a 17-year-old high school student with epilepsy.
In response to the recent survey results, Hargis said, “It’s frustrating because the Epilepsy Foundation is an organization committed to research—committed to bringing new treatment options—and yet people are not always receiving the best care possible.” He cited the ongoing stigma associated with epilepsy, even though it is a common condition that affects more people than Parkinson’s, multiple sclerosis and cerebral palsy combined. He said the mystery, ignorance and fear that surround epilepsy affect every aspect of a person with epilepsy’s life, including interpersonal relationships and employment.
Hargis asked how we could get beyond the stigma associated with epilepsy and Greg Grunberg responded, “It’s all about talking about it.” Dr. Montouris concurred, saying that epilepsy needs to be brought out more in the open in order to eliminate stigma. She said it is important not to “fear epilepsy, but address the situation.” Panelist Caitlin Purcell wanted everyone to know her epilepsy is “not as bad as it seems.” Even so, she said other kids were still afraid of her and scared about what might happen if they were out with her and she had a seizure. She is strongly focused on getting the word out and being honest with her friends about her condition, in the hopes that full disclosure will lead to a better understanding.
Another survey finding revealed that seventy-five percent of patients experience side effects with their medication that have a major impact on their daily lives, but they are not discussing them with their HCPs. The panelists emphasized that patients need to be empowered because having seizure freedom with side effects is not a reasonable tradeoff. Dr. Montouris said, “The patient has to take the role—this is your life, this is your body.” She added, “How many seizures are too many? In my book, one.”
The survey pointed to reluctance among patents to discuss any medication side effects or problems with their treatment, such as ongoing seizures. HCPs as well as caregivers and patients all agreed that being your own advocate and being informed about all of the treatment options are essential. All of the HCPs encouraged patients to seek a second opinion if they are not happy with their treatment, and assured them that seeking a second opinion will not hurt the HCP’s feelings; it’s about finding the best treatment for your condition.
In wrapping up the discussion, Hargis asked what was on the horizon in the field of epilepsy. The HCPs encouraged further clinical trials in order to advance new drugs in the pipeline. They also stressed that everyone with epilepsy, regardless of socio-economic status, should have the same access to care. Dr. Labiner noted that as more and more people develop epilepsy at all different ages, people will become more aware of the disorder. He said, “It is a problem that spans the ages.”
After the roundtable, Grunberg and Geoff Pope patiently signed autographs for the kids—and adults—in the audience and posed for pictures. Caitlin Purcell’s father stood proudly on the sidelines watching his daughter mingle with the crowd. He said, “I’m really happy that she gets the opportunity to see she is not alone. I think that’s an important thing for all of the patients with epilepsy to understand—they are not alone. The stigma has got to be overcome.”
Letter from Emfit explaining new Seizure Alarms
As most of you know, Emfit has been on an up-hill struggle with the FDA for over a year in an attempt to obtain clearance to market our Epileptic Seizure Alarm in the United States. Unfortunately, we were not able to succeed due to certain concerns regarding how these types of products should be regulated in the United States.
It is important that you know that the FDA has not yet determined exactly what is required for approval of epileptic seizure alarm products, and as a result there are currently NO FDA-approved seizure alarms available, despite claims that have been made from manufacturers in and outside of the U.S. We pride ourselves on our integrity and will only follow the legal route when it comes to distributing any of our devices. While this may mean a loss of sales, we are still morally obligated to our customers.
Our products have been tried and tested throughout Europe and Australia for over 5 years and we are confident that you will be equally satisfied with our new motion monitor we are about to legally introduce into the United States within the next two weeks. For the FDA approval reasons above, this monitor will not be intended for, or labeled specifically for, any particular medical use (for example, as an epilepsy alarm) but instead, will be sold as a consumer nighttime motion detector for any type of sustained nighttime movement. The price will remain a reasonable $850.00, plus shipping and handling, and will include our proprietary, patented, ultra-responsive movement detection sensor, and control unit with volume adjustment and pre-set delay (see below).
We will be accepting Visa, MasterCard, PayPal, and Money Orders, and you may buy directly from us or purchase from our online store at www.emfit.com . We will be accepting pre-orders, but will not charge any credit card until the product is ready to ship to you. Unfortunately, insurance will not be able to cover this new system for the simple fact that we cannot list or label it as a medical device. The product comes with a great warranty and a 30-day money-back guarantee in case you are not completely satisfied with its performance.
Please do not hesitate to contact me with any questions. I look forward to (at long last) bringing peace of mind to everyone who has been waiting for a system such as ours.
Emfit Corp., U.S.A.
10909 Vanowen St. Suite 300
North Hollywood, CA 91605
*This is not an endorsement of Emfit's product. This is posted in response to increased product awareness and desire for information.
Epilepsy Foundation Takes Action Against Hackers
Landover, MD, March 31, 2008— The Epilepsy Foundation’s quick reaction to a recent attack by hackers on one of its online forums raises awareness of the need for Web security for some health organizations. On Easter weekend, the Epilepsy Foundation—and those who use its online forums for help, support, suggestions and camaraderie—came under attack by people who posted rapidly flashing images to cause serious injury and harm. The type of epilepsy that causes people to experience seizures upon seeing flashing or flickering images is photosensitive epilepsy.
Barrages of messages are oftentimes problematic for electronic venues, but nothing more than a nuisance, or a potential embarrassment if pornographic images are included in the attacks. But for people with epilepsy, rapidly flashing text or images can cause actual harm to the person viewing the material, because such flashing or flickering objects can bring on seizures, or seizure-like activity. In fact, many people who viewed the at-first harmless-looking messages recently posted on the Foundation’s forums involuntarily froze when they saw what was posted, even if they didn’t experience a full-on seizure.
“This was clearly an act of vandalism with the intent to harm people, and we shut the attack down immediately,” said Eric R. Hargis, president and CEO of the Epilepsy Foundation. “We’ve established deterrents in the system to prevent similar incidences.”
The Epilepsy Foundation has been on the forefront of efforts to prevent this type of seizure. Three years ago the organization assembled a group of experts on photic- and pattern-induced seizures and released its recommendations for preventing seizures provoked by dynamic light and imaging sources such as television, videogames, websites, motion pictures and other media. The consensus recommendations covered factors, such as light intensity, flicker, contrast, duration and pattern, and the technical parameters within these factors that are most likely to provoke seizures in susceptible individuals.
More than 3 million Americans have epilepsy (approximately one in every 100); while about 3 percent of those people have photosensitive epilepsy. Photosensitive epilepsy has been in the news increasingly over the last few years because it has triggered seizures in people in newsworthy ways, including recently when a logo animation for the 2012 Olympics in Britain caused thousands of people to experience seizures and, previously, when a few years ago an episode of an animated TV series caused thousands of children to experience seizures in Japan. Some video games have also caused children to have seizures even if they’ve never previously displayed any seizure-like behaviors. Such warnings are included on most—if not all—video games today as a result. Though the Japanese government established guidelines following the incidences in that country, the Epilepsy Foundation’s Seizures and Photosensitivity
guidelines are the only such recommendations in the United States.
Children’s Lives May be Endangered as Child Care Centers Refuse to Administer Emergency Medication
Landover, MD (March 13, 2008) — The Epilepsy Foundation recently joined in a lawsuit against a national chain of child care centers that refuses to administer a potentially life-saving medication to children with epilepsy. The suit was originally filed on behalf of an 8-year-old California boy when a Tutor Time Learning Centers, LLC, child care center refused to administer diazepam rectal gel (sold under the brand name Diastat AcuDial). The Foundation has joined the lawsuit as a plaintiff to represent the many children with epilepsy around the country who may have been prevented from attending any of the 200 child care centers affiliated with the Tutor Time chain because of their refusal to administer this medication.
Diastat AcuDial is the standard out-of-hospital FDA-approved medication for prolonged seizures, which may cause brain injury or death if not promptly treated. It was specifically approved by the FDA for administration by people without medical training—such as parents, child care workers and school personnel—who can do so safely and easily. Children with epilepsy are particularly susceptible to prolonged seizures that may cause serious brain injury or death if not promptly treated, yet the child care provider’s only plan was to call 911.
“Most child care providers quickly understand that administering this medication is the right and necessary action to take,” said Eric R. Hargis, president and CEO of the Epilepsy Foundation. “Unfortunately, many other providers do not understand and may put children at risk and create an unnecessary burden on families who cannot find safe child care.”
Because the Americans with Disabilities Act prohibits discrimination against people with disabilities in public accommodations, including child care centers, Tutor Time must modify its policy against administering this medication to afford children with epilepsy equal access to the company’s services. Tutor Time has provided no reasonable justification for its policy. “When a patient begins to have prolonged or recurrent seizures outside of their normal patterns, it’s [a condition] that needs to be treated immediately,” said James W. Wheless, M.D., professor and chief of pediatric neurology at the University of Tennessee Health Science Center. “In the United States, the amount of time that typically elapses between the onset of a seizure and a patient receiving treatment at a hospital can exceed one hour. That’s too long [to rely on 911 for treatment]. [Diazepam rectal gel] is a safe, effective treatment.”
A similar lawsuit against an Army-operated child care center that refuses to administer diazepam rectal gel is currently pending in Kentucky.
FDA Accepts for Review OVATION’s Two NDA Submissions for Sabril®
Priority Review Granted for Infantile Spasms with Concurrent Reviewfor Refractory Complex Partial Seizures
OVATION Pharmaceuticals, Inc. announced on February 27, 2008, that the U.S. Food and Drug Administration (FDA) has accepted the company’s new drug applications (NDA) for Sabril® (vigabatrin) in two types of epilepsies. The FDA assigned a priority NDA review for Sabril for the treatment of Infantile Spasms (IS), and will review the submission for refractory complex partial seizures (CPS) in the same time frame. Sabril is currently under review by the FDA for use as a monotherapy for patients with IS and as an adjunctive treatment for adults with refractory CPS. A priority review designation is given to drugs that provide treatment where no adequate therapy exists, or that offer major advances in treatment.
To date, there are no medications approved by the FDA for the treatment of Infantile Spasms, a devastating form of epilepsy which usually strikes infants in the first year of life. In the United States, Infantile Spasms constitute about two percent of childhood epilepsies, and 25 percent of epilepsies with onset in the first year of life. Infants with IS suffer spasms that typically last for one to five seconds and occur in clusters of up to 100 spasms at a time.
Complex Partial Seizures are epileptic attacks that cause impaired consciousness and originate from a single region of the brain. About one-third of patients with CPS are unresponsive, or refractory, to treatment with many first- or second-line antiepileptic drugs (AEDs). In patients with refractory CPS, these treatments may only reduce the frequency and severity of the seizures, rather than providing complete seizure control.
Source: Adapted from a press release from Ovation Pharmaceuticals
Epilepsy Foundation Professional Advisory Board Members Respond to FDA Announcement on AEDs
We at the Epilepsy Foundation feel that the recent announcement linking suicidal thoughts with antiepileptic drugs should not cause anyone to become frightened about taking their medications. Reacting to this FDA warning by abruptly stopping an antiepileptic medication could be very dangerous and is better handled by calling your doctor to discuss any concerns.
Individuals taking antiepileptic medications can feel reassured by a number of factors. Since depression is very common in epilepsy, we don't know for sure if some individuals had suicidal thoughts that were not in fact caused by the medications. We need to get much more information about how these statistics were derived. Even if medications do raise the risk, this risk is very low. The risk of developing this problem after long-term use of a drug is probably especially low if a person has been feeling fine up until now.
The Epilepsy Foundation has always supported the idea that health care providers need to spend time looking for and talking about depression with their epilepsy patients. We hope that the main impact of the recent FDA announcement will be to reinforce the value of good communication between patients and their health care providers.
Alan Ettinger, M.D., Vice-Chairman, Department of Neurology, Long Island Jewish Medical Center (LIJMC); Professor of Clinical Neurology, Albert Einstein College of Medicine; Director, North Shore-LIJ Comprehensive Epilepsy Centers and Chief Division of EEG and Epilepsy, LIJMC. Dr. Ettinger serves on the Quality of Life committee of the Epilepsy Foundation’s Professional Advisory Board.
Bruce Hermann, Ph.D., Professor of Neurology at the University of Wisconsin School of Medicine and Public Health. Dr. Hermann is the chair of the Epilepsy Foundation’s Professional Advisory Board.
Brian Alldredge, PharmD, Professor of Clinical Pharmacy & Neurology; Associate Dean, Academic Affairs, School of Pharmacy, University of California, San Francisco. Dr. Alldredge serves on the Research Council committee of the Epilepsy Foundation’s Professional Advisory Board.