Posted by halcyondaze on January 24, 2007, at 15:50:18
On January 17, 2007 there was a change to the labeling of Seroquel, with a warning added that it may cause increased depression and suicidality. AstraZeneca must not be happy, as they're running clinical trials for Seroquel XR monotherapy for depression as we speak.
Thoughts?
<< http://www.medscape.com/viewarticle/550891?rss >>
Quetiapine Fumarate Tablets (Seroquel) Linked to Risks for Worsened Depression and Suicidality
On October 20, 2006, the FDA approved safety labeling revisions for quetiapine fumarate (Seroquel tablets, made by AstraZeneca Pharmaceuticals, LP) to warn that adult and pediatric patients with major depressive disorder (MDD) can experience worsening of their condition and/or the emergence of suicidal ideation and behavior (suicidality), whether or not they are receiving antidepressant therapy. This risk can persist until significant remission occurs.The role of antidepressants in inducing suicidality and worsening depression in certain patients remains unclear, but it is supported by an analysis of pooled data from 24 short-term (up to 4 months), placebo-controlled trials of 9 antidepressant drugs (including selective serotonin reuptake inhibitors) in more than 4400 children and adolescents with MDD, obsessive-compulsive disorder, and other psychiatric disorders.
Results showed that treatment with antidepressants significantly increased the mean risk for suicidality relative to placebo (4% vs 2%). Although the risk varied considerably among drugs, most drugs showed a tendency toward increasing the risk for suicidality. When analyzed by condition treated, the risk was most consistent in MDD patients, but signals of risk were noted in patients with other psychiatric disorders (obsessive-compulsive disorder and social anxiety disorder). No suicides occurred in any of the trials.
It is not known whether the suicidality risk in pediatric patients extends to longer-term use (beyond several months) or to adults. Quetiapine is not indicated for any pediatric conditions.
Adults with MDD or comorbid depression receiving antidepressant therapy should be monitored closely for clinical worsening, suicidality, and unusual changes in behavior — particularly during the initial few months of therapy and during increases/decreases in dose. Monitoring should include weekly face-to-face contact with patients or their family members/caregivers during the first month of treatment, then contact every other week for the next month, once at 3 months, and thereafter as clinically indicated.
The following symptoms have been reported in adult and pediatric patients receiving antidepressant therapy for MDD, as well as other psychiatric and nonpsychiatric indications: anxiety, agitation, panic attacks, insomnia, irritability, hostility, aggressiveness, impulsivity, akathisia, hypomania, and mania. Although a causal role for these symptoms and worsening of depression/emergence of suicidal impulses has not been established, there is concern that they are precursors to emerging suicidality.
The FDA notes that consideration should be given to changing or discontinuing the therapeutic regimen in patients with persistently worsening depression, suicidality, or potentially related precursors, particularly if the symptoms are severe, abrupt in onset, or were not part of the patient's presenting symptoms. If discontinuation is warranted, quetiapine should be tapered as quickly as possible, keeping in mind that abrupt cessation of therapy can lead to certain symptoms.
Quetiapine is indicated for the treatment of schizophrenia, for use alone or in combination with lithium or divalproex in the treatment of acute manic episodes associated with bipolar I disorder, and for the treatment of depressive episodes associated with bipolar disorder.
poster:halcyondaze
thread:726032
URL: http://www.dr-bob.org/babble/20070119/msgs/726032.html