Navigation Links
FDA Proposes New Warnings About Suicidal Thinking, Behavior in,Young Adults Who Take Antidepressant Medications

antidepressants. At that time, FDA asked manufacturers to add a black box warning to the labeling of all antidepressants to describe this risk and to emphasize the need for appropriate monitoring and close observation, particularly for younger patients taking these medications. In addition, FDA directed manufacturers to develop Medication Guides, FDA-approved user-friendly information for patients, families and caregivers, that could help improve monitoring. Medication Guides are intended to be distributed at the pharmacy with each prescription or refill of a medication.

Also in 2005, FDA began a comprehensive review of 295 individual antidepressant trials that included over 77,000 adult patients with major depressive disorder (MDD) and other psychiatric disorders, to examine the risk of suicidality in adults who are prescribed antidepressants.

In December 2006, FDA's Psychopharmacologic Drugs Advisory Committee agreed that labeling changes were needed to inform health care professionals about the increased risk of suicidality in younger adults using antidepressants. Additionally, the committee noted product labeling needed to reflect the apparent beneficial effect of antidepressants in older adults and to remind health care professionals that the disorders themselves are the most important cause of suicidality.

FDA has been developing language to revise product labeling and update the Patient Medication Guides for these products. Manufacturers of antidepressants will now have 30 days to submit their revised product labels and revised Medication Guides to FDA for review.

Products involved in today's action include:

Anafranil (clomipramine)
Asendin (amoxapine)
Aventyl (nortriptyline)
Celexa (citalopram hydrobromide)
Cymbalta (duloxetine)
Desyrel (trazodone HCl)
Elavil (amitriptyline)
Effexor (venlafaxine HCl)
Emsam (selegiline)
Etrafon (perphenazine/amitriptyline)
fluvoxam
'"/>




Page: 1 2 3

Related medicine technology :

1. Reaction to Avandia Warnings Stronger Among Internists Than Endocrinologists, According to Study by GfK Market Measures
2. Geron Corp. Licensee TA Sciences Announces Landmark 7/07/07 Teleconference to Answer Questions About TA-65, Their Telomerase Activator With Proven Age Management Benefits
3. Women Well-Informed About Breast Cancer, Yet Lacking Knowledge About Current Treatments, New Survey Finds
4. International Movement Disorder Specialists Receive New Information About the Use of Once-Daily Azilect in the Treatment of Parkinsons Disease
5. Six Important Things to Know About Preventing Hospital Infections
6. New Phase 3 Study Published in The Lancet Evaluates Efficacy and Safety of Prezista/Ritonavir vs. Kaletra as Part of HIV Combination Therapy in Treatment-Experienced Adults With HIV
7. Study Demonstrated Rozerem (ramelteon) Does Not Affect Middle-of-the-Night Balance in Older Adults with Insomnia
8. New Study Suggests no Significant Impairment in Middle-of-the-Night Balance, Mobility or Memory in Older Adults Using Ramelteon
9. New Study Results Provide Additional Data about Short- and Long-Term Use of Desvenlafaxine Succinate in the Treatment of Adults with Major Depressive Disorder
10. Pooled Studies Showed Desvenlafaxine Succinate Significantly Improved Painful Symptoms and Anxious Symptoms Associated with Major Depressive Disorder in Adults, Compared With Placebo
11. Six-Week Investigational Study In Adults With Major Depressive Disorder Evaluates The Effectiveness of Adjunctive Aripiprazole Therapy With Antidepressants
Post Your Comments:
(Date:7/31/2015)... , July 31, 2015  Xencor, Inc. (NASDAQ: ... monoclonal antibodies for the treatment of autoimmune diseases, asthma ... of Yujiro S. Hata to its board ... in business and corporate development is a tremendous asset ... president and chief executive officer of Xencor. "Xencor faces ...
(Date:7/30/2015)... IRVINE, Calif. , July 30, 2015 Edwards ... the science of heart valves and hemodynamic monitoring, today announced ... company,s Board of Directors. "Bob is an ardent ... been a true privilege to have him on Edwards, board ... A. Mussallem , Edwards, chairman and CEO.  "Bob has provided ...
(Date:7/30/2015)... Calif. , July 30, 2015 IRIDEX ... will release its second quarter 2015 financial results after ...   In conjunction with the release, the Company will ... 5:00 p.m. Eastern Time on Thursday, ... the quarter and other business developments. Interested ...
Breaking Medicine Technology:Xencor Appoints Yujiro S. Hata to Board of Directors 2Xencor Appoints Yujiro S. Hata to Board of Directors 3IRIDEX Announces Second Quarter 2015 Conference Call and Release Date 2
... human-animal hybrids to generate stem cells WORCESTER, Mass., ... Sheets: ACTC) and its collaborators reported today that human ... adult human cells. The research, which appears online ahead ... Cells (Editor-in-Chief: Sir Ian Wilmut; published by Mary ...
... Robert C. Gallo Foundation for AIDS and Virus ... as director of international relations. The foundation ... internationally known for expertise in HIV prevention, treatment ... producing groundbreaking HIV research."It is an honor to ...
Cached Medicine Technology:Cloned Human Embryos Successfully Reprogrammed Using Human - But Not Animal - Eggs 2Cloned Human Embryos Successfully Reprogrammed Using Human - But Not Animal - Eggs 3Cloned Human Embryos Successfully Reprogrammed Using Human - But Not Animal - Eggs 4Cloned Human Embryos Successfully Reprogrammed Using Human - But Not Animal - Eggs 5Franco Nuschese Tapped by Robert C. Gallo Foundation for AIDS and Virus Research 2
(Date:8/1/2015)... ... 2015 , ... AlignLife Office Coordinator Heather Pugh earned the position ... patients at this natural health care center in Winamac. , "Oftentimes patients are in ... role is vital to our approach because we want to focus on the patient ...
(Date:8/1/2015)... ... August 01, 2015 , ... ... in “a trending profession” that comprises a growing percentage of U.S. physicians, and ... , That was one part of the message delivered by John W. Becher, ...
(Date:8/1/2015)... ... August 01, 2015 , ... The condition where veins are enlarged and gnarled ... causing pain and discomfort. Those who spend a lot of time on their feet ... Center is doing what it can to create awareness and provide a cure in ...
(Date:8/1/2015)... (PRWEB) , ... August 01, 2015 , ... Tina Wilcoxson, ... Champions.” , Wilcoxson was given that honor by the National Retail Federation, the largest ... industry. Wilcoxson was one of three Maine business owners to be named as such. ...
(Date:8/1/2015)... NY and Greenwich, CT (PRWEB) , ... August ... ... (“Professional”), a Great Point Partners I, L.P. (“GPP”) portfolio company has acquired Premier ... Connecticut — incorporating it into its portfolio of state-of-the-art clinics. , “Our acquisition ...
Breaking Medicine News(10 mins):Health News:New Patient Advocate Enhances Natural Health Care 2Health News:COMP-Northwest Welcomes Class of 2019 2Health News:COMP-Northwest Welcomes Class of 2019 3Health News:COMP-Northwest Welcomes Class of 2019 4Health News:COMP-Northwest Welcomes Class of 2019 5Health News:Northeast Houston Vein Center Warns Men about Varicose Veins 2Health News:Northeast Houston Vein Center Warns Men about Varicose Veins 3Health News:Local Retail Advocate Wins National Recognition 2Health News:Professional Physical Therapy Now Largest Outpatient Physical Therapy Provider in Northeast With Acquisition of Premier Physical Therapy & Wellness 2
... after 163 sickened in 17 states, CDC reports , , ... current outbreak of salmonella in tomatoes, consumers will need ... types of tomatoes for a while. , "The best ... trying to find out exactly where the tomatoes they,re ...
... from a record breaking year of food recalls and ... light the science --,and the politics -- behind food ... nuclear industries., Written plainly and passionately, Wenonah Hauter,s ... fact-filled. The book details the rise,of irradiation in the ...
... In First Acquisition Since Investment from IAC/InterActive Corp, ... of Patient Engagement Capabilities, ARLINGTON, Va., June ... announced today the acquisition of consumer health,information company ... size,of HealthCentral,s email newsletter reach and offers advertisers ...
... to Teaching Hospital ... Serving Fourth Largest Population Center, DENVER, June 10 ... international e-Health, medical,information technology company, today announced that its ... SafeTrace,Tx(R) transfusion management software to Riverside County Regional Medical,Center ...
... Inc.,(OTC Bulletin Board: TONJ), a premier provider of Healthcare ... enjoying an,influx of patients due to Natural events in ... a private enterprise, Vice Minister of Health Gao,Qiang told ... would,pick up the costs of care to earthquake victims, ...
... helps ... VERNON HILLS, Ill., June 10 Zebra,Technologies (Nasdaq: ... solutions for the healthcare industry, has introduced,the first cartridge-based ... cost-effective for healthcare organizations., "Missing or illegible wristbands ...
Cached Medicine News:Health News:Consumers Urged to Avoid Certain Tomatoes Amid Salmonella Scare 2Health News:Consumers Urged to Avoid Certain Tomatoes Amid Salmonella Scare 3Health News:New Book Reveals Decades-Long Food Safety PR Scam 2Health News:The HealthCentral Network Acquires MedTrackAlert, Extending its Ability to Reach Highly Engaged Online Health Consumers 2Health News:The HealthCentral Network Acquires MedTrackAlert, Extending its Ability to Reach Highly Engaged Online Health Consumers 3Health News:The HealthCentral Network Acquires MedTrackAlert, Extending its Ability to Reach Highly Engaged Online Health Consumers 4Health News:Global Med Technologies(R) Signs Agreement With California's Century Old Riverside County Regional Medical Center 2Health News:Global Med Technologies(R) Signs Agreement With California's Century Old Riverside County Regional Medical Center 3Health News:Tongji Healthcare Services Reports Influx of Patients 2Health News:Zebra Technologies Introduces HC100(TM) Patient I.D. Wristbanding Solution 2Health News:Zebra Technologies Introduces HC100(TM) Patient I.D. Wristbanding Solution 3
The Triage Profiler Shortness of Breath Panel provides rapid risk assessment and differential diagnosis of patients presenting to the emergency department with shortness of breath and risk assessment...
... an affordable path to Sonesta flexibility. ... and back adjustments. Packaged with basic ... line of Sonesta add-ons, allowing you ... your needs; complete Sonesta flexibility at ...
... The Sonesta 6202 is ... Packaged with our most popular ... equipped for a myriad of ... powerful (yet quiet) motors allow ...
... bilirubin levels with no pain, no waiting ... the traditional heel stick method or blood ... without regard to gender, gestational age or ... the babys forehead, which reduces the risk ...
Medicine Products: