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

ROCKVILLE, Md., May 2, 2007-The U.S. Food and Drug Administration (FDA) today proposed that makers of all antidepressant medications update the existing black box warning on their products' labeling to include warnings about increased risks of suicidal thinking and behavior, known as suicidality, in young adults ages 18 to 24 during initial treatment (generally the first one to two months).

The proposed labeling changes also include language stating that scientific data did not show this increased risk in adults older than 24, and that adults ages 65 and older taking antidepressants have a decreased risk of suicidality. The proposed warning statements emphasize that depression and certain other serious psychiatric disorders are themselves the most important causes of suicide.

"Today's actions represent FDA's commitment to a high level of post-marketing evaluation of drug products," said Steven Galson, M.D., MPH, director of FDA's Center for Drug Evaluation and Research. "Depression and other psychiatric disorders can have significant consequences if not appropriately treated. Antidepressant medications benefit many patients, but it is important that doctors and patients are aware of the risks."

People currently prescribed antidepressant medications should not stop taking them. Those who have concerns should notify their health care providers.

The proposed labeling changes apply to the entire category of antidepressants. Results of individual placebo-controlled scientific studies are reasonably consistent in showing a slight increase in suicidality for patients taking antidepressants in early treatment for most of the medications. Available data are not sufficient to exclude any single medication from the increased risk of suicidality.

The proposed labeling update follows similar labeling changes made in 2005 that warned of a suicidality risk in children and adolescents who use 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 ine maleate
Lexapro (escitalopram hydrobromide)
Limbitrol (chlordiazepoxide/amitriptyline)
Ludiomil (maprotiline)
Marplan (isocarboxazid)
Nardil (phenelzine sulfate)
nefazodone HCl
Norpramin (desipramine HCl)
Pamelor (nortriptyline)
Parnate (tranylcypromine sulfate)
Paxil (paroxetine HCl)
Pexeva (paroxetine mesylate)
Prozac (fluoxetine HCl)
Remeron (mirtazapine)
Sarafem (fluoxetine HCl)
Seroquel (quetiapine)
Sinequan (doxepin)
Surmontil (trimipramine)
Symbyax (olanzapine/fluoxetine)
Tofranil (imipramine)
Tofranil-PM (imipramine pamoate)
Triavil (perphenazine/amitriptyline)
Vivactil (protriptyline)
Wellbutrin (bupropion HCl)
Zoloft (sertraline HCl)
Zyban (bupropion HCl)

For more information:

Antidepressant use in children, adolescents, and adults, including the draft labeling and draft Medication Guides

FDA's Psychopharmacologic Drugs Advisory Committee, including transcripts from the December 2006 meeting


Media Inquiries:
Sandy Walsh, 301-827-6242
Consumer Inquiries:


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:12/1/2015)... Russia has always been a ... new drugs registered in Europe in 2015 were ... Russia has always been a country of choice ... in Europe in 2015 were tested in phase ... Russia has always been a country of choice for global ...
(Date:12/1/2015)... , Dec. 1, 2015 CytRx Corporation (NASDAQ: ... specializing in oncology, today announced that it has reached ... pivotal global Phase 3 clinical trial of aldoxorubicin in ... originally estimated to be completed in Q1 2016. The Phase ... under a Special Protocol Assessment from the FDA at ...
(Date:12/1/2015)... 1, 2015  The migration to value-based care ... care plans that help patients stay healthy and ... be digitally enabled, incorporate care guidelines and be ... They will also allow all stakeholders to collaborate ... is optimal. That is the vision, however, research ...
Breaking Medicine Technology:
(Date:12/1/2015)... (PRWEB) , ... December 02, 2015 , ... Ruth Pearson ... brutal lupus flare-up. Unable to walk without assistance and quickly losing hope of recovering ... then a miracle happened. , Pearson was attending a women’s retreat when she experienced ...
(Date:12/1/2015)... ... December 01, 2015 , ... The Multiple System Atrophy Coalition ... funds for Multiple System Atrophy (MSA) research, timed today to coincide with Giving Tuesday ... from patients including their ability to work and be productive, to do simple daily ...
(Date:12/1/2015)... , ... December 01, 2015 , ... Royal River Natural ... new study that found post-menopausal women who took the nutritional supplement creatine, along with ... who trained but did not take creatine. , The report is part of the ...
(Date:12/1/2015)... , ... December 01, 2015 , ... ... leadless pacemakers in the U.S. and is the only hospital in the region ... largest clinical data presentation of transcatheter pacing patients were revealed recently at a ...
(Date:12/1/2015)... ... 01, 2015 , ... December 1, 2015 -- InstantLabs is ... growing product line of food safety and seafood fraud prevention tools. , The ... allow InstantLabs to offer fast, reliable species identification for the four most popular ...
Breaking Medicine News(10 mins):