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Manufacturer admits increase in suicidal behaviour in patients taking paroxetine

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  1. Micklemouse
    [FONT=verdana,arial,helvetica,sans-serif] BMJ 2006;332:1175 (20 May), doi:10.1136/bmj.332.7551.1175 [/FONT]

    News roundup


    Manufacturer admits increase in suicidal behaviour in patients taking paroxetine

    New York Jeanne Lenzer

    GlaxoSmithKline announced last week that they had found an increase in suicidal behaviour in adults taking paroxetine (Paxil/Seroxat) compared with placebo. The conclusion was based on an analysis of patients aged 18-64 years in clinical trials.


    The researchers found that 0.32% (11/3455) of people taking paroxetine for depression attempted suicide compared with 0.05% (1/1978) of depressed patients taking placebo (odds ratio 6.7, 95% confidence interval 1.1 to 149.4; P=0.058). One person in the paroxetine group successfully killed themselves. GlaxoSmithKline said the data should be interpreted with caution and that the “overall risk-benefit of paroxetine in the treatment of adult patients with MDD [major depressive disease] remains positive.”


    The Glaxo study confirms the suggested link between suicidal behaviour and antidepressants in adults. In October 2004, the US Food and Drug Administration ordered drug companies to place a “black box” warning on all antidepressants, saying that suicidal behaviour might increase in children and adolescents taking the drugs. They requested all manufacturers of antidepressants to examine their data for a similar link among adults. The FDA is undertaking its own pooled analysis of adults taking antidepressants and is expected to release its results as soon as this summer.
    In 2004, the Medicines and Healthcare Regulatory Agency advised physicians not to prescribe paroxetine or any other selective serotonin reuptake inhibitor to children. In light of the recent study by Glaxo, the agency issued a reminder to physicians on 10 May stating that “careful and frequent monitoring . . . is important in the early stages of treatment with paroxetine, especially if a patient experiences worsening of symptoms or if new symptoms arise after starting treatment.”


    In August 2005, researchers in Norway obtained missing and unreported data from clinical trials of paroxetine and reported that there were seven suicide attempts among 916 patients taking paroxetine compared with one attempt in 550 patients taking placebo (www.biomedcentral.com/1741-7015/3/14). The researchers concluded that, “Patients and doctors should be warned that the increased suicidal activity observed in children and adolescents taking certain antidepressant drugs may also be present in adults.”

    Glaxo rebutted the study findings at the time, in part because the “analysis was based solely on early data submitted to regulatory authorities in 1989.” However, the company provided the FDA with its own pooled analysis in March 2006, in which GSK researchers concluded that, “In adults with MDD (all ages), there was a statistically significant increase in the frequency of suicidal behaviour in patients treated with paroxetine compared with placebo.”


    GSK sent a letter to doctors stating, “It is difficult to conclude a causal relationship between paroxetine and suicidality in adults due to the small incidence and absolute number of events, the retrospective nature of the analyses, and potential for confounding by the fact that the events of interest are a symptom of the psychiatric illnesses themselves.”


    The current finding is the most recent of a series of setbacks for the drug. In December 2005, the FDA issued an alert stating that “paroxetine increases the risk of congenital malformations” in children exposed in utero to paroxetine during the first trimester, according to preliminary results of two recent studies. The most common malformation, according to a news release by GSK, is ventricular septal defect.


    Another setback came when US marshals seized lots of a sustained release form of paroxetine (Paxil CR) in early March this year because of concerns about manufacturing quality that the FDA said could “pose a significant health hazard to consumers.”



    Oops-i-lah!

Comments

  1. Nagognog2
    Back in the early 1990's, police agencies were given a warning that people who were taking SSRI-class anti-depressants posed a significant risk of being homicidal/suicidal in any confrontations. So this has been known for well over a decade. Just kept quiet to all but a few who might have a "need-to-know." It's all about money.
  2. bewilderment
    I thought this was an established fact some time ago. Or maybe it didn't apply to Paxil specifically. Psychiatric meds can have all sorts of weird effects. I was prescribed Buspar once upon a time (which is an anti-anxiety medication) and even though I was depressed beforehand, once the Buspar got into my system I suddenly felt like a leaden object. I could barely move. Gravity was super-strong. Not only that, but I decided that it was a good idea that I stop talking to people. It made perfect logical sense to me at the time. My mother got mad at me because my grandmother was visiting at the time and I refused to talk to her or anyone else, just grunting and pointing. I immediately quit taking it, of course, and things returned to normal. I was also prescribed Paxil at that point in time. I found Paxil to be a nasty antidepressant. It took away all of my emotions and I can see why one would be inclined to kill themselves when they don't feel anything anyway. Also, it's frequently noted that depressed people sometimes simply don't have the energy or motivation to kill themselves even if this is what they currently desire. Then they pop some antidepressants and all of a sudden they get a little boost of energy and they can carry out their plan they've had forever.

    Also, for me personally, I always saw medication as a last resort especially after my debacle with Paxil (this was when I was in a minor and I didn't have much of a say about whether I wanted medication or not, my mother did). My depression went away for a little while after I the age of 16 and didn't pop up again until around the age of 19. I saw psychiatric meds as evil and I never had much luck with therapy. However, I always had these options in my mind as something to fall back on if I decided I couldn't handle it anymore alone. Then, if I found that the treatment didn't work and I had tried all my options then I would go ahead and commit suicide. I distinctly remember getting up one morning while I was living on campus at a university and at this point I had been suicidal and depressed for awhile and as a result of being depressed my performance in school had dropped considerably. My grades were fine before, mostly A's with a few B's but depression screws with your memory, attention, concentration, etc. so at this point I maybe had an A in one or two classes while having perhaps a D in another, an F in another and failing a lab or two as well. Needless to say, I felt worthless especially considering that I was actually working very hard, all I did was study but I couldn't retain anything. I was also not using drugs at this time so that was not the cause. Anyway, so that particular morning I got up and immediately began bawling around 6am after crying myself to sleep the night before. I'd had enough so I got up and got dressed all the while planning on driving to my mother's home where I knew she would not be present and either shooting myself or slitting my wrists after taking some pills. I thought about it and thought about it and more and more the health center on campus was looking pretty damn good to me. I still didn't know where I was going as I walked out the door that morning, but luckily I sauntered over to the health center and went to see a psychologist. She gave me a brief assessment. I was perfectly calm the entire time and answered her questions truthfully. She asked me if I'd contemplated suicide and I said 'yes'. She asked me if I had a plan and I said "more or less". She asked me did I think I could carry it out and I said "some days, I believe I could". It seems that a warning sign that a person is really serious is when they are unusually calm about such things. Needless to say she was alarmed...I didn't expect that. She asked what classes I was taking and I was taking a pretty heavy courseload at this point in time: calc II, botany, botany lab, organic chemistry, organic chemistry lab, philosophy of the mind, and some dumb intro to college class that was required for everyone. She suggested I take a medical withdrawal and I thought that was a dumb idea and said so. She also suggested that I be put on Zoloft. I told her that I'd previously not found antidepressants to be useful and I didn't want to be put on medication. We argued over it a few minutes and I finally decided it couldn't hurt that much considering I was about to go kill myself anyway. So, she personally escorted me to the MD on campus and he talked to me and gave me some samples of Zoloft to tide me over. He also suggested I take a medical withdrawal, a strategic retreat so to speak. Now, in my case, Zoloft was like a miracle drug at that time period. Within about a month or so my mood had significantly increased, although, I believe this also had something to do with going ahead and taking a withdrawal and I also began smoking marijuana regularly after I withdrew from school. So, it quite literally saved my life.

    Now, had something else happened and I found the Zoloft did not work and I was still depressed and suicidal. I most likely would've gone ahead committed suicide. It makes me wonder how often this happens. This could be a cause of some of the deaths related to Paxil and other drugs. Then again, as I said above, psychiatric meds sometimes do strange things so I know there are other causes as well.

    Anyway, forgive my rambling, I've been drinking a bit and am feeling chatty and probably more forthcoming than usual.
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