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:5/5/2016)... ... May 05, 2016 , ... Dental365 in Levittown opened just a few ... dentistry. Dental365 was established with the patient’s comfort and convenience in mind. ... high-quality, affordable dentistry while offering routine and walk-in emergency dental care 365 days a ...
(Date:5/4/2016)... ... May 05, 2016 , ... “Less than 15% of organizations nationwide can ... “As one of ten non-profit organizations to participate and complete the training, we are ... benefit is that for every $1 we invest in volunteer engagement, we can expect ...
(Date:5/4/2016)... ... May 04, 2016 , ... The manufacturer of the SOCKIT ... trainers to St. Jude Children’s Research Hospital to benefit families dealing with cancer ... designed to teach children how to kick a soccer ball correctly. The device ...
(Date:5/4/2016)... ... May 04, 2016 , ... NCPDP ... conference opened on Tuesday with Frank Luntz, sharing a dynamic, bi-partisan environmental scan ... a deep dive on NCPDP’s model solution to help stem the tide of ...
(Date:5/4/2016)... ... May 04, 2016 , ... The Lymphoma Research ... lymphoma research and serving the lymphoma community through a comprehensive series of education ... esteemed Quaker Ridge Golf Club in Scarsdale, New York on May 23, 2016 ...
Breaking Medicine News(10 mins):
(Date:5/4/2016)... JERUSALEM , May 4, 2016 ... University of Jerusalem announced today that it had ... BioTheryX, Inc. , developer of novel protein degradation ... the development and commercialization of drug candidates representing first-in-class ... the license were not disclosed. The novel ...
(Date:5/4/2016)... , May 4, 2016 ... addition of the  "Global Acute Myeloid Leukemia ...  report to their offering.       ... Acute Myeloid Leukemia Market and Competitive Landscape ... Myeloid Leukemia pipeline products, Acute Myeloid Leukemia ...
(Date:5/3/2016)... -- Research and Markets has announced the ... Market Outlook 2020" report to their offering. ... technology has improved significantly in past years due to ... coming years. Many cancer drugs have been developed by ... also expected to be developed with its help. They ...
Breaking Medicine Technology: