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Dr. Bob is Robert Hsiung, MD,
bob@dr-bob.orgShown: posts 1 to 13 of 13. This is the beginning of the thread.
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.
Posted by linkadge on January 24, 2007, at 16:18:48
In reply to Seroquel label change - increased depression?, posted by halcyondaze on January 24, 2007, at 15:50:18
Yeah, thats crazy. It certainly made me more depressed.
So, its indicated for bipolar depression, but It can cause depression.
I think we've entered the bizzaro-world.
Linkadge
Posted by ed_uk on January 24, 2007, at 16:25:58
In reply to Re: Seroquel label change - increased depression?, posted by linkadge on January 24, 2007, at 16:18:48
I've never been as unhappy as I was after taking an antipsychotic. I've never taken Seroquel though.
Ed
Posted by Phillipa on January 24, 2007, at 17:32:26
In reply to Re: Seroquel label change - increased depression?, posted by ed_uk on January 24, 2007, at 16:25:58
This may be great news for benzophobic docs as they have been using atypical antipsychotics instead of benzos so horray from me. Love Phillipa ps bet the docs are not happy about this. As benzos may soon be back in vogue or this will spur researchers to find a drug that is good for anxiety, panic etc.
Posted by med_empowered on January 24, 2007, at 17:41:41
In reply to Re: Seroquel label change - increased depression?, posted by Phillipa on January 24, 2007, at 17:32:26
Do you think its a marketing move? Of all the atypicals, Seroquel is the one I associate *least* with schizophrenia--I think bipolar, sleep, anxiety, but not so much schizophrenia. Maybe this label was just a move to reinforce their marketing as an AD. Also, maybe it just shows the company knows alot of people on Seroquel are on it waaay off-label, and they felt they should smack the label on there to cover themselves in terms of liability. Or...maybe it is just trying to sell a neuroleptic as an antidepressant.
Anyway...neuroleptics suck. I wish docs would lay off rx-ing them for everything and just stick to cheaper, safer stuff. Sigh. Oh well.
Posted by craiggetty on January 24, 2007, at 22:35:54
In reply to Re: Seroquel label change - increased depression?, posted by med_empowered on January 24, 2007, at 17:41:41
Been taking 25mg Seroquel every night for sleep for past 6 months. Works great. I need to take it 2 hours before going to bed or I have trouble waking up in the morning and feel sluggish during the day.
Posted by SLS on January 25, 2007, at 5:39:06
In reply to Seroquel label change - increased depression?, posted by halcyondaze on January 24, 2007, at 15:50:18
Seroquel made me somewhat dysphoric. I just didn't like it, and aborted the trial. Seroquel can have a robust antidepressent effect, although I have not personally seen this occur as monotherapy. I've seen it augment Wellbutrin quite effectively, though. Like anything else, it depends on the person. One interestingly effective combination that I have observed for psychotic bipolar depression (mixed state) is Wellbutrin + Risperdal 3.0mg + Seroquel 100mg.
- Scott
Posted by craiggetty on January 25, 2007, at 16:21:32
In reply to Re: Seroquel label change - increased depression?, posted by SLS on January 25, 2007, at 5:39:06
Hi Scott,
I agree it depends on the person, the condition, the med combo, etc. I'm also taking Wellbutrin, Adderall, and Lamictal so the Seroquel (and a beer) help me wind down for bed.
Craig
Posted by yxibow on January 26, 2007, at 3:47:22
In reply to Re: Seroquel label change - increased depression?, posted by craiggetty on January 25, 2007, at 16:21:32
The labeling PI change doesn't mention Seroquel intrisically and talks about antidepressant medications as an agglutinate, a collective ("pooled analysis"). It also includes the usual adolescent may off themselves label that seems to be attached to every antidepressant these days when in fact with serious childhood MDD there can be just as equal risks untreated. Not every school rampage occurs just because a psychotic kid happens to be on Prozac, its because the parents are out to lunch and we (in the US) live in a gun happy society.
I imagine that its possible for any medication to worsen a condition but typically antipsychotics are second to lithium for rapid treatment of suicidality and depression.
While it causes other side effects that I can't tolerate at the moment, Zyprexa lifted my spirits within days. Can't say one way or the other for Seroquel but I can say in general that of course antipsychotics have a blunting effect. That blunting effect could be interpreted as disreality, which in turn is dysphoria and depression for some. Its an unfortunate side effect of all neuroleptics. But I'm not really sure whether the sedation is more "blunting" than the "blunting".
Seroquel's main problem for me is the antihistamine effect; if they could have figured how to remove the H1 from the molecule it would be quite desirable for its otherwise low side effect profile in most people.-- tidings
Posted by psychobot5000 on January 26, 2007, at 12:47:47
In reply to Re: Seroquel label change - increased depression?, posted by SLS on January 25, 2007, at 5:39:06
> Seroquel made me somewhat dysphoric. I just didn't like it, and aborted the trial. Seroquel can have a robust antidepressent effect, although I have not personally seen this occur as monotherapy.
>
Ditto, more or less. Tried it as an antidepressant augmentor, and as a sleep aid, and both times, I felt it was lowering my mood slightly, so I stopped. The effect was milde but it didn't seem to be just the H1 blocking, sedative effects.But I've definitely seen evidence (abstracts and such) that seroquel is an antidepressant in some people.
Posted by Phillipa on January 26, 2007, at 18:30:20
In reply to Re: Seroquel label change - increased depression?, posted by psychobot5000 on January 26, 2007, at 12:47:47
My theory in a lot of cases mine included is that anxiety leads to depression so could it be that seroquel eliminates the anxiety hence no depression? Love Phillipa
Posted by linkadge on January 26, 2007, at 20:02:25
In reply to Re: Seroquel label change - increased depression?, posted by Phillipa on January 26, 2007, at 18:30:20
As for the atypicals on mood, zyprexa was the most tollerable, followed by seroqel, risperdal just made me plain depressed.
Linkadge
Posted by Clockwork Ange on January 29, 2007, at 11:45:13
In reply to Re: Seroquel label change - increased depression?, posted by yxibow on January 26, 2007, at 3:47:22
For me, Seroquel gets me out of a mania... which would then make me feel depressed because I'm no longer manic... but I must say it definitely helps me sleep when I'm manic- which is usually impossible and makes everything 100xs worse.
This is the end of the thread.
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