Navigation Links
FDA Advisers Don't Back Epilepsy Drug Warnings
Date:7/10/2008

Experts do find 11 anti-seizure drugs heighten suicide risk, and they recommend medication guide for doctors

THURSDAY, July 10 (HealthDay News) -- Anti-seizure drugs can cause increased suicidal tendencies in patients, but not enough to warrant the government's strongest warning label on them, a U.S. health advisory panel concluded Thursday.

The 20-member panel voted unanimously, with one abstention, to back the findings on 11 antiepileptic drugs studied by the U.S. Food and Drug Administration.

In late January, the FDA announced it was considering a black-box warning after an agency review of 199 studies comparing the drugs, which are used by millions, to placebos. That review found that patients taking the drugs had about twice the risk of suicidal behavior compared with patients taking a placebo.

"We have concluded this was a real signal, and the signal applied to all drugs we studied," Dr. Russell Katz, director of the division of neurology products at the FDA's Center for Drug Evaluation and Research, told reporters at a late-afternoon teleconference Thursday.

"We propose that labels for all these antiepileptic drugs be changed to include a box warning, and patients should be given a medication guide describing these events with each prescription refill," he said.

On Thursday, the advisory panel appeared to agree with him -- up to a point. It voted in favor of sending a medication guide to doctors detailing the suicide risks.

But a majority of panel members voted against adding the black box warning, saying the studies didn't show a high-enough risk for suicidal behavior.

"The general view of the committee was concern that patients or physicians would not prescribe these drugs in certain circumstances where they should," Katz said. "The committee voted 14 'no, it should not be described in a box warning, although it should be described in the label somewhere.' There were
'/>"/>

Copyright©2008 ScoutNews,LLC.
All rights reserved  

Page: 1 2

Related medicine news :

1. FDA Advisers Urge Ban on Cold Medicines for Young Children
2. U.S. Advisers OK Nasal Spray Flu Vaccine for Young Children
3. FDA Advisers Reject Over-the-Counter Statin
4. Growing Link Between Diabetes and Periodontal Disease Focus of National Gathering for Health Care Leaders
5. Treating your periodontal pockets may benefit your pocket book
6. Ortho Organizers(R) Announces the Launch of the Ancor Pro(TM) Orthodontic Anchorage System Hands-on Course
7. Survey confirms Americans prefer root canal treatment by endodontists
8. Most With High Blood Pressure Dont Follow Recommended Diet
9. Watch Your Mouth: Michigan Association of Endodontists Offers Four Part Series on Keeping Your Teeth Healthy
10. NYU dental researchers find evidence of periodontal disease leading to gestational diabetes
11. HPV, periodontitis work in tandem to increase risk of tongue cancer
Post Your Comments:
*Name:
*Comment:
*Email:
Related Image:
FDA Advisers Don't Back Epilepsy Drug Warnings
(Date:4/20/2015)... 2015 At the famous Avalon Hollywood ... Movie Awards” EcoLuxe Lounge, with Choices Recovery as the ... of sustainable product placement in TV and film, gathered ... and ecologically sound goods and services for this daylong ... hosted the Choices Celebrity Interview Lounge, speaking with many ...
(Date:4/20/2015)... (PRWEB) April 20, 2015 Western ... Donahue, DNP, RN, NEA-BC, FAAN who was named ... Education and Research in September 2014, is transitioning ... Officer to lead the development of Western Connecticut ... newly created role, Donahue will be responsible for ...
(Date:4/20/2015)... NJ (PRWEB) April 20, 2015 The normal ... stroke. There’s nothing more we could do.” Especially if the ... , Today, the response should be much different. So it’s ... question: “What more can be done?” , Not every ... “There is something that can be done.” But, according to ...
(Date:4/20/2015)... York (PRWEB) April 20, 2015 ... representing the U.S. health insurance industry, is seeking ... of the recent controversy involving surgical tools called ... to U.S. Senator Robert Casey (D-PA) dated April ... surrounding uterine morcellation point to “serious gaps in ...
(Date:4/20/2015)... 20, 2015 TROY Healthcare Solutions will ... Enterprise (TSPE) software, which provides the ultimate level of ... 6 at the Anthem Suite Hotel in the Socrates ... 11 AM. , Beginning at 7 AM, TROY Healthcare ... AM, TROY Healthcare Solutions will offer brief 15-20 minute ...
Breaking Medicine News(10 mins):Health News:Choices Recovery South Bend Talks About Healthy Decisions with TV's Adrienne Janic 2Health News:Nursing Executive to Develop and Lead Nursing Leadership Program at Western Connecticut Health Network 2Health News:"What More Can Be Done?” – The Critical Question That Can Save a Stroke Victim 2Health News:"What More Can Be Done?” – The Critical Question That Can Save a Stroke Victim 3Health News:Power Morcellator Lawyers at Bernstein Liebhard LLP Comment on Insurance Trade Group’s Call for Greater Regulation of Medical Devices 2Health News:Power Morcellator Lawyers at Bernstein Liebhard LLP Comment on Insurance Trade Group’s Call for Greater Regulation of Medical Devices 3Health News:Power Morcellator Lawyers at Bernstein Liebhard LLP Comment on Insurance Trade Group’s Call for Greater Regulation of Medical Devices 4Health News:TROY Healthcare to Offer Prescription Solutions that Could Save a Health System $100,000 2Health News:TROY Healthcare to Offer Prescription Solutions that Could Save a Health System $100,000 3
... marketing, products and customer relations, FARMINGTON HILLS, ... provider of laser hair removal and other noninvasive,aesthetic ... of Bill,Van Huis as the company,s chief revenue ... is responsible for generating profitable,revenues for the organization ...
... 25 Imagenetix, Inc. (OTC Bulletin,Board: IAGX), announced ... and its Executive Committee has selected Celadrin(R),Topical Cream ... since 1928,was to provide the best medical care ... Games. Now it has expanded its goal to ...
... Advancement of Interoperability within ... ... Greenway Medical Technologies,Inc., a leading provider of integrated electronic ... the Integrating the Healthcare Enterprise (IHE) Connectathon in Chicago.,The ...
... Intelligence Solutions to the Healthcare ... ... HIMSS, Booth #1841 --,Harris Corporation (NYSE: HRS ), an international ... enterprises during the Healthcare,Information and Management Systems Society (HIMSS) annual conference ...
... Intelligence Applications Enables ... Transition to Digital Pathology, ... technology to enable pathologists and other medical,professionals to view, ... environment is being demonstrated publicly for,the first time by ...
... in HIMSS Highlights Myriad Opportunities for Using Wireless ... to Improve Efficiency and Accuracy of Patient Care, ... provider of intelligent wireless LANs (WLANs) for enterprises and,service ... HIMSS,Conference & Exhibition, taking place February 24-28 in Orlando, ...
Cached Medicine News:Health News:American Laser Centers Names Bill Van Huis as Chief Revenue Officer 2Health News:International Federation of Sports Medicine Selects Celadrin(R) Topical Cream as it's First and Only Official Joint and Muscle Topical Cream 2Health News:International Federation of Sports Medicine Selects Celadrin(R) Topical Cream as it's First and Only Official Joint and Muscle Topical Cream 3Health News:Greenway Medical Technologies Strengthens Industry Leadership With Participation in the IHE Connectathon and HIMSS Interoperability Showcase 2Health News:Greenway Medical Technologies Strengthens Industry Leadership With Participation in the IHE Connectathon and HIMSS Interoperability Showcase 3Health News:Greenway Medical Technologies Strengthens Industry Leadership With Participation in the IHE Connectathon and HIMSS Interoperability Showcase 4Health News:Harris Corporation Demonstrates Digital Signage(TM) Solutions for Dynamic, Rapid Communications within Healthcare Enterprises 2Health News:Harris Corporation Demonstrates Digital Signage(TM) Solutions for Dynamic, Rapid Communications within Healthcare Enterprises 3Health News:Harris Corporation Demonstrates Remote Digital Imagery Display and Manipulation for Pathology Applications 2Health News:Harris Corporation Demonstrates Remote Digital Imagery Display and Manipulation for Pathology Applications 3Health News:Colubris Demonstrates Wide-Ranging Mobility Solutions for Healthcare 2
(Date:4/20/2015)... Increasing unnecessary regulations on drug plans could ... get their medications through a managed drug plan, according ... for Policy Analysis Senior Fellow Devon Herrick. ... managed efficiently helps makes medications affordable," says Herrick. "Blatant ... as consumer protections, but more often than not they ...
(Date:4/20/2015)... , April 20, 2015 International ... pleased to provide shareholders with the following update ... Products Historically, INIS has ... to fabricate several models of sealed sources for ... such as radiation therapy, security examination, and radiography.  ...
(Date:4/20/2015)... , April 20, 2015 Stand Up To Cancer ... of a $20 million Dream Team to attack the number ... the Annual Meeting of the American Association for Cancer Research ... that 221,000 people in the United States ... 2015, and 158,040 will die from it, making lung cancer ...
Breaking Medicine Technology:Restrictive Drug Plan Regulations Will Hurt Patients 2International Isotopes Inc. Provides Shareholders With An Update On New Opportunities And Positive Developments Within Its Existing Business Segments 2International Isotopes Inc. Provides Shareholders With An Update On New Opportunities And Positive Developments Within Its Existing Business Segments 3International Isotopes Inc. Provides Shareholders With An Update On New Opportunities And Positive Developments Within Its Existing Business Segments 4International Isotopes Inc. Provides Shareholders With An Update On New Opportunities And Positive Developments Within Its Existing Business Segments 5New SU2C-American Cancer Society Lung Cancer Dream Team Announced 2New SU2C-American Cancer Society Lung Cancer Dream Team Announced 3New SU2C-American Cancer Society Lung Cancer Dream Team Announced 4New SU2C-American Cancer Society Lung Cancer Dream Team Announced 5New SU2C-American Cancer Society Lung Cancer Dream Team Announced 6
... 2011 Raylene Riha and her husband, Michael, filed ... Johnson, Inc. seeking compensation for injuries caused by failures ... that have been recalled.  John David Hart of the ... Texas, is the attorney representing Raylene and Michael Riha ...
... (Tianjin) Co. Ltd, a leading research-based contract manufacturer of advanced ... the U.S. and China, is pleased to announce the recent ... Assurance as of March 1, 2011. Mr. ... the pharmaceutical industry (early and late stage), in quality assurance ...
Cached Medicine Technology:Law Offices of John David Hart: DePuy Recalled Hip Device Lawsuit Filed by Houston Woman 2Mr. Robert Andrews Joins Asymchem Life Science (Tianjin) Co. Ltd. as Vice President of Quality Assurance 2
... ARUP Laboratories is a national reference ... laboratory research and development. ARUP offers an ... unique medical tests in clinical and anatomic ... ARUP Laboratories' clients include more than half ...
... Laboratories is a national reference laboratory and ... and development. ARUP offers an extensive test ... tests in clinical and anatomic pathology. Owned ... clients include more than half of the ...
... national reference laboratory and a worldwide leader ... offers an extensive test menu of highly ... and anatomic pathology. Owned by the University ... than half of the nation's university teaching ...
... ARUP Laboratories is a national reference ... laboratory research and development. ARUP offers an ... unique medical tests in clinical and anatomic ... ARUP Laboratories' clients include more than half ...
Medicine Products: