Suicidality Reports Prompt Advisory: FDA Sets Stage for Debate on Antidepressants, Kids; Expert Panels to Discuss Data Next Year

By Mechcatie, Elizabeth | Clinical Psychiatry News, December 2003 | Go to article overview

Suicidality Reports Prompt Advisory: FDA Sets Stage for Debate on Antidepressants, Kids; Expert Panels to Discuss Data Next Year


Mechcatie, Elizabeth, Clinical Psychiatry News


The Food and Drug Administration's public health advisory about the reports of suicidality among pediatric patients treated with antidepressant drugs for major depressive disorder is a result of a preliminary review of such reports in patients on various antidepressants.

The FDA released the advisory to alert physicians to reports of suicidality in clinical studies of various antidepressants in pediatric patients with major depressive disorder (MDD). Although cases of suicidality "are not unexpected in patients with MDD, preliminary data suggest an excess of such reports" among patients who have been on some of those drugs compared with those on placebo, the advisory states. The advisory emphasizes that these data "do not clearly establish an association between the use of these drugs and increased suicidal thoughts or actions by pediatric patients," but that an increased risk cannot be ruled out at the present time.

The reports were in patients on the following antidepressants: selective serotonin reuptake inhibitors (SSRIs), fluoxetine (Prozac), fluvoxamine (Luvox), paroxetine (Paxil), sertraline (Zoloft), and citalopram (Celexa); as well as venlafaxine (Effexor), mirtazapine (Remeron), and nefazodone (Serzone).

All eight brand name antidepressants have been studied under the pediatric exclusivity provision of the FDA Modernization Act of 1997, which created a financial incentive for manufacturers to study their products in children.

There were no reports of completed suicides in the 20 placebo-controlled trials of these drugs in more than 4,100 pediatric patients. Cases of suicide attempts and completed suicides in pediatric patients have been reported in the press and in medical journals but "are very difficult to interpret, in the absence of a control group, as these events also occur in untreated patients with depression," the advisory says.

The FDA's Psychopharmacologic Drugs Advisory Committee and a pediatric subcommittee will hold a joint meeting in February, when the data and possible regulatory actions will be discussed by the panels, made up of outside experts in the related fields. …

The rest of this article is only available to active members of Questia

Already a member? Log in now.

Notes for this article

Add a new note
If you are trying to select text to create highlights or citations, remember that you must now click or tap on the first word, and then click or tap on the last word.
One moment ...
Default project is now your active project.
Project items
Notes
Cite this article

Cited article

Style
Citations are available only to our active members.
Buy instant access to cite pages or passages in MLA 8, MLA 7, APA and Chicago citation styles.

(Einhorn, 1992, p. 25)

(Einhorn 25)

(Einhorn 25)

1. Lois J. Einhorn, Abraham Lincoln, the Orator: Penetrating the Lincoln Legend (Westport, CT: Greenwood Press, 1992), 25, http://www.questia.com/read/27419298.

Note: primary sources have slightly different requirements for citation. Please see these guidelines for more information.

Cited article

Suicidality Reports Prompt Advisory: FDA Sets Stage for Debate on Antidepressants, Kids; Expert Panels to Discuss Data Next Year
Settings

Settings

Typeface
Text size Smaller Larger Reset View mode
Search within

Search within this article

Look up

Look up a word

  • Dictionary
  • Thesaurus
Please submit a word or phrase above.
Print this page

Print this page

Why can't I print more than one page at a time?

Help
Full screen
Items saved from this article
  • Highlights & Notes
  • Citations
Some of your highlights are legacy items.

Highlights saved before July 30, 2012 will not be displayed on their respective source pages.

You can easily re-create the highlights by opening the book page or article, selecting the text, and clicking “Highlight.”

matching results for page

    Questia reader help

    How to highlight and cite specific passages

    1. Click or tap the first word you want to select.
    2. Click or tap the last word you want to select, and you’ll see everything in between get selected.
    3. You’ll then get a menu of options like creating a highlight or a citation from that passage of text.

    OK, got it!

    Cited passage

    Style
    Citations are available only to our active members.
    Buy instant access to cite pages or passages in MLA 8, MLA 7, APA and Chicago citation styles.

    "Portraying himself as an honest, ordinary person helped Lincoln identify with his audiences." (Einhorn, 1992, p. 25).

    "Portraying himself as an honest, ordinary person helped Lincoln identify with his audiences." (Einhorn 25)

    "Portraying himself as an honest, ordinary person helped Lincoln identify with his audiences." (Einhorn 25)

    "Portraying himself as an honest, ordinary person helped Lincoln identify with his audiences."1

    1. Lois J. Einhorn, Abraham Lincoln, the Orator: Penetrating the Lincoln Legend (Westport, CT: Greenwood Press, 1992), 25, http://www.questia.com/read/27419298.

    Cited passage

    Thanks for trying Questia!

    Please continue trying out our research tools, but please note, full functionality is available only to our active members.

    Your work will be lost once you leave this Web page.

    Buy instant access to save your work.

    Already a member? Log in now.

    Search by... Author
    Show... All Results Primary Sources Peer-reviewed

    Oops!

    An unknown error has occurred. Please click the button below to reload the page. If the problem persists, please try again in a little while.