Navigation Links
FDA Warning of Suicidal Risk Associated with Antidepressants in Juveniles and Young Adults Reviewed at Recent ISCTM Meeting
Date:3/6/2008

WASHINGTON, March 6 /PRNewswire-USNewswire/ -- The International Society for CNS Clinical Trials and Methodology (ISCTM) held its 2008 annual meeting in Washington, DC, February 25-27. This organization involves collaborative efforts among academic and research clinicians, representatives of the pharmaceutical industry, and governmental drug-regulatory bodies to improve methods for testing efficacy and safety of drugs used to treat psychiatric and neurological disorders. A half-day symposium explored FDA-required "black-box" drug safety warnings of evidence of increased risk of suicidal thoughts and actions during treatment with antidepressants in juvenile and young-adult patients as a case study. The symposium was chaired by FDA-advisor Andrew Leon, Ph.D. (Cornell Medical Center), and Ross J. Baldessarini, M.D. (Harvard Medical School). Other speakers were Neil Chayet, J.D. (Harvard Medical School), Thomas Laughren, M.D. (US FDA), James McNulty (Past-President, National Alliance on Mental Illness [NAMI]), and Sharon-Lise Normand, Ph.D. (Harvard School of Public Health).

Dr. Baldessarini noted: "Studies aimed at reducing risk of suicide remain far less well developed than many other treatments for psychiatric patients, despite the importance of the problem. Evidence of whether antidepressants increase or reduce risk of suicidal behaviors remains surprisingly inconsistent and inconclusive."

Symposium speakers reviewed evidence supporting the expanded safety warning for all drug products that are FDA-approved for the treatment of major depression, that involve 180-million prescriptions a year in the US. The FDA also is conducting a systematic review of suicidal risks associated with anti-epilepsy drugs and considering use of more systematic assessments of suicidal thinking and behaviors to replace current incidental patient and clinician reporting of adverse events during trials.

Suggestions for further action discussed at the symposium include the need for longer studies of both potential beneficial and adverse effects of various medicines that act on the brain, as well as greater collaborative relationships and more open information-sharing among psychiatric patients, clinicians, researchers, the pharmaceutical industry, and FDA. Redoubled efforts are needed to identify more tolerable, safer and more effective treatments for depression, and to limit suicidal risks, as well as adequate information to guide sound treatment planning so as to balance risks and benefits of antidepressant treatment. ISCTM plans to continue its consideration of methods for suicide assessment with drugs that act on the brain, and approaches to treatments aimed at reducing suicidal risks.

For information on ISCTM: http://www.isctm.org.


'/>"/>
SOURCE International Society for CNS Clinical Trials andMethodology
Copyright©2008 PR Newswire.
All rights reserved

Related medicine news :

1. Warning: Expert at UH adds obesity to side effects of lead exposure
2. Warning! Doctors, Insurers Hold Patients Hostage! Says Top Acupuncture Physician
3. Early warning: PSA testing can predict advanced prostate cancer
4. Leading National Patient Advocacy Group Delivers Warning to U.S. Patients: Having Health Insurance Does NOT Mean Your Medical Needs Will Be Covered
5. FairWarning to Host Webinar Featuring HIMSS Chairman and Healthcare Executive from PricewaterhouseCoopers on Electronic Health Record Privacy and Compliance Challenges
6. Geisinger study: PTSD a medical warning sign for long-term health problems
7. FairWarning(R) Furthers Electronic Health Record Privacy Auditing Leadership
8. EpicTide Changes Name to FairWarning(R)
9. Youth Suicide Warnings Are Slowing Antidepressant Sales
10. FDA Renews Warnings on Pain-Relief Patch
11. FDA Warning for N-9 - an Opportunity for VivaGel(R)
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:10/13/2017)... ... ... Apple Rehab Shelton Lakes , which specializes in the delivery of sub-acute ... of a disaster drill on October 3rd. , Apple Rehab participated with the Shelton ... well as the Connecticut Long Term Care Mutual Aid Plan (LTC-MAP). The LTC-MAP ...
(Date:10/13/2017)... ... , ... Yisrayl Hawkins, Pastor and Overseer at The House of Yahweh, has ... least understood books in the Holy Scriptures, Revelation. The Book of Revelation paints a ... centuries. Many have tossed it off as mere rubbish, but Yisrayl Hawkins says that ...
(Date:10/12/2017)... , ... October 12, 2017 , ... ... services for healthcare compliance program management, will showcase a range of technology and ... for Assisted Living (NCAL) Convention and Expo to be held October 14–18, 2017 ...
(Date:10/12/2017)... ... October 12, 2017 , ... The American College of Medical Informatics (ACMI) will ... during the Opening Session of AMIA’s Annual Symposium in Washington, D.C. AMIA’s Annual ... F. Collen, a pioneer in the field of medical informatics, this prestigious award is ...
(Date:10/12/2017)... ... October 12, 2017 , ... Leading pediatric oncology experts at Children’s National ... 49th Congress of the International Society of Paediatric Oncology (SIOP) Oct. 12-15. ... for Cancer and Blood Disorders at Children’s National, and Stephen P. Hunger, M.D., ...
Breaking Medicine News(10 mins):
(Date:10/2/2017)... , Oct. 2, 2017 The Rebound mobile ... the struggle to reverse the tide of prescription drug addiction. ... regulating their medicine intake and stepping down their dosage in ... to launch in December 2017; the first 100,000 people to ... more at http://www.rebound-solution.com/ ...
(Date:9/27/2017)... Sept. 27, 2017  Commended for their devotion to personalized ... Ranked as number one in the South Florida Business Journal,s ... Inc. 5000 yearly list, the national specialty pharmacy has found ... Bardisa will soon be honored by SFBJ as the ... Set to receive his award in October, Bardisa ...
(Date:9/25/2017)... , Sept. 25, 2017  EpiVax, Inc., a ... design, and immune-engineering today announced the launch of ... development of personalized therapeutic cancer vaccines. EpiVax has ... exclusive access to enabling technologies to the new ... will lead EpiVax Oncology as Chief Executive Officer. ...
Breaking Medicine Technology: