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:6/24/2016)... ... June 24, 2016 , ... A recent article published June 14 ... The article goes on to state that individuals are now more comfortable seeking to ... operations such as calf and cheek reduction. The Los Angeles area medical group, Beverly ...
(Date:6/24/2016)... ... ... Marcy was in a crisis. Her son James, eight, was out of control. Prone to ... , “When something upset him, he couldn’t control his emotions,” remembers Marcy. “If there ... my other children and say he was going to kill them. If we were ...
(Date:6/24/2016)... , ... June 24, 2016 , ... ... offering micro-osteoperforation for accelerated orthodontic treatment. Dr. Cheng has extensive experience with all ... brackets , AcceleDent, and accelerated osteogenic orthodontics. , Micro-osteoperforation is a revolutionary ...
(Date:6/24/2016)... ... ... People across the U.S. are sharpening their pencils and honing their writing ... which patients and their families pay tribute to a genetic counselor by nominating him ... Genetic Counselors (NSGC) Annual Education Conference (AEC) this September. , In April, Genome ...
(Date:6/24/2016)... ... June 24, 2016 , ... Puradigm® & Innovative Solutions today ... cultivation and processing operations at its production facility, and opened its first two ... the manufacturer of a complete system of proactive air and surface purification solutions ...
Breaking Medicine News(10 mins):
(Date:6/24/2016)... June 24, 2016 Research and Markets ... for Companion Diagnostic Tests" report to their offering. ... Companion Diagnostics The World Market for Companion ... medicine diagnostics. Market analysis in the report includes the following: ... (In Vitro Diagnostic Kits) by Region (N. America, EU, ROW), ...
(Date:6/23/2016)... -- MedSource announced today that it has selected Datatrial,s ... choice.  This latest decision demonstrates MedSource,s commitment to ... by offering a state-of-the-art electronic data capture (EDC) ... the EDC platform of choice in exchange for ... long been a preferred EDC platform by our ...
(Date:6/23/2016)... 2016 Roche (SIX: RO, ROG; OTCQX: RHHBY) ... Elecsys BRAHMS PCT (procalcitonin) assay as a dedicated testing ... With this clearance, Roche is the first IVD company ... for sepsis risk assessment and management. PCT ... PCT levels in blood can aid clinicians in assessing ...
Breaking Medicine Technology: