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:6/25/2016)... ... June 25, 2016 , ... "With 30 hand-drawn hand ... project," said Christina Austin - CEO of Pixel Film Studios. , ProHand Cartoon’s ... within Final Cut Pro X . Simply select a ProHand generator and drag ...
(Date:6/25/2016)... ... June 25, 2016 , ... Conventional wisdom preaches the benefits of moderation, ... the latter, setting the bar too high can result in disappointment, perhaps even self-loathing. ... toward their goal. , Research from PsychTests.com reveals that behind the ...
(Date:6/24/2016)... Texas (PRWEB) , ... June 24, 2016 , ... ... International Conference and Scientific Sessions in Dallas that it will receive two significant ... of the grants came as PHA marked its 25th anniversary by recognizing patients, ...
(Date:6/24/2016)... ... June 24, 2016 , ... People across the U.S. are sharpening their pencils ... an essay contest in which patients and their families pay tribute to a genetic ... 2016 National Society of Genetic Counselors (NSGC) Annual Education Conference (AEC) this September. ...
(Date:6/24/2016)... ... , ... National recruitment firm Slone Partners is pleased to announce ... experience, as Vice President of North American Capital Sales at HTG Molecular . ... sales team in the commercialization of the HTG EdgeSeq system and associated reagents in ...
Breaking Medicine News(10 mins):
(Date:6/24/2016)... , June 24, 2016  Collagen Matrix, Inc., ... development and manufacturing of collagen and mineral based ... today that Bill Messer has joined ... to further leverage the growing portfolio of oral ... Bill joins the Collagen Matrix executive ...
(Date:6/24/2016)... The Academy of Managed Care Pharmacy (AMCP) ... would allow biopharmaceutical companies to more easily share health ... and coverage decisions, a move that addresses the growing ... The recommendations address restrictions in the sharing of ... label, a prohibition that hinders decision makers from accessing ...
(Date:6/24/2016)... , June 24, 2016   Pulmatrix, Inc ... company developing innovative inhaled drugs, announced today that it ... Russell Investments reconstituted its comprehensive set of U.S. ... "This is an important milestone for Pulmatrix," said ... increase shareholder awareness of our progress in developing drugs ...
Breaking Medicine Technology: