My oldest son took this for years, and was inched up to about 200 mg. per day. Then it made him manic and violent, possibly because it was combined with a stimulant (Adderall). I believe at the time there was also something about children taking it were at risk of possible suicide risk I found this listing regarding it.
Quote:
As you know, on October 15, 2004, the FDA announced heightened warnings for all antidepressants - including Zoloft. These drugs labels are required to include Black Box warnings, acknowledging that a causal relationship has been established between antidepressants and an increased risk of suicide. The wording in the black box warnings must conform to FDA-approved language.
The decision requiring a Black Box warning for antidepressants comes after a protracted, deliberative process which many have criticized as foot dragging. The FDA held two advisory committee meetings, conducted three separate analyses of the pediatric clinical trial data, and issued three public advisories (June 19, 2003; October, 2003; and March 22, 2004).
The following section, formatted as it appears in the revised Zoloft label--with bold in the original - conforms with the FDA March 22, 2004 requirement. The Zoloft label was approved on August 19, 2004. (Almost identical language and formatting appears on the labels of the other SSRI antidepressants).
WARNINGS:
"Clinical Worsening and Suicide Risk
Patients with major depressive disorder, both adult and pediatric, may experience worsening of their depression and/or the emergence of suicidal ideation and behavior (suicidality), whether or not they are taking antidepressant medications, and this risk may persist until significant remission occurs. Although there has been a long-standing concern that antidepressants may have a role in inducing worsening of depression and the emergence of suicidality in certain patients, a causal role for antidepressants in inducing such behaviors has not been established. Nevertheless, patients being treated with antidepressants should be observed closely for clinical worsening and suicidality, especially at the beginning of a course of drug therapy, or at the time of dose changes, either increases or decreases. Consideration should be given to changing the therapeutic regimen, including possibly discontinuing the medication, in patients whose depression is persistently worse or whose emergent suicidality is severe, abrupt in onset, or was not part of the patient's presenting symptoms.
Because of the possibility of co-morbidity between major depressive disorder and other psychiatric and nonpsychiatric disorders, the same precautions observed when treating patients with major depressive disorder should be observed when treating patients with other psychiatric and nonpsychiatric disorders.
The following symptoms: anxiety, agitation, panic attacks, insomnia, irritability, hostility (aggressiveness), impulsivity, akathisia (psychomotor restlessness), hypomania, and mania, have been reported in adult and pediatric patients being treated with antidepressants for major depressive disorder as well as for other indications, both psychiatric and nonpsychiatric. Although a causal link between the emergence of such symptoms and either the worsening of depression and/or the emergence of suicidal impulses has not been established, consideration should be given to changing the therapeutic regimen, including possibly discontinuing the medication, in patients for whom such symptoms are severe, abrupt in onset, or were not part of the patient's presenting symptoms.
Families and caregivers of patients being treated with antidepressants for major depressive disorder or other indications, both psychiatric and nonpsychiatric, should be alerted about the need to monitor patients for the emergence of agitation, irritability, and the other symptoms described above, as well as the emergence of suicidality, and to report such symptoms immediately to health care providers.
from this source:
http://www.ahrp.org/infomail/04/11/01.php
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I tried to get in touch with my feminine side.... but it got a restraining order.....
04 Jan 2008, 4:53 pm
