Paxil and Suicide-Confirmed in trials


    Shamed Glaxo's u-turn on 'suicide' drug
    by BEEZY MARSH and TIM UTTON, Daily Mail

    08:49am 15th June 2004
    Britain's biggest drugs firm has caved in dramatically and revealed research which shows a leading anti-depressant can cause children to attempt suicide.
    In an astonishing u-turn, Glaxo-SmithKline finally published full details of nine scientific studies and two clinical reviews which expose the dangers posed to under-18s who take Seroxat.

    Children on Seroxat are twice as likely to have suicidal thoughts than those on a dummy pill, it emerged.

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    Alarmingly, one study showed six youngsters on Seroxat wanted to kill themselves, compared to just one taking a placebo pill.
    The drug was also linked to distressing side effects including hostility, insomnia, dizziness, tremors and emotional irritability.

    Damning findings

    Campaigners say the damning findings were suppressed for up to a decade while thousands of teenagers and children as young as six continued to be given the pills to ease depression.

    At one point, doctors had even hailed Seroxat as a "wonderdrug" to help people overcome shyness.

    The firm is facing a major lawsuit amid allegations that drug regulators were duped into thinking Seroxat - which is worth 2billion a year to Glaxo - was safe for children.

    A number of youngsters are known to have committed suicide while taking the drug, but it was not until last year that doctors were banned from prescribing it to under-18s because of the suicide risk.

    Some estimate that more than 50,000 under-18s in the UK were prescribed Seroxat between 1990, when it was licensed here, and last year when the ban was imposed by Government medical regulators.

    Anguished parents

    Anguished parents have complained that their children became suicidal while on Seroxat then showed horrendous withdrawal symptoms when they tried to come off it.

    A civil lawsuit has been filed against Glaxo in the US by New York State attorney general Eliot Spitzer, who claims the firm suppressed at least four studies on the drug.

    More than 3,000 UK families have also started legal action against Glaxo seeking compensation for their ordeal. They include a number of parents whose children committed suicide while on

    Seroxat. Full details of the controversial studies were published on the Internet only after the medical establishment turned on Glaxo.

    In an unprecedented attack, the respected Lancet medical journal last week accused the drugs giant of losing touch with its basic humanity over the Seroxat scandal.

    'Suicidal thinking'

    In an editorial, the journal said: "GSK appears to be floundering in the semantic depths.

    "While it has been earnestly parsing the meaning of 'suicidal thinking' and 'publicly', it appears to have forgotten what lies behind those words - people. The time has come for these matters to be revealed in a bright and public light."

    The Lancet said the safety and efficacy of Seroxat in children had been tested in "at least five studies sponsored by GSK, only one of which has been published".

    It revealed that, although the results of this trial were mixed, they were heralded in a memo as showing "remarkable efficacy and safety in the treatment of adolescent depression".

    The Lancet also poured scorn on Glaxo's argument that trials data was made public. This was done at scientific meetings attended only by specialists and published in the letters pages of medical journals.

    Medical authorities here are investigating whether Glaxo complied with legal requirements to make all relevant clinical trial data on the drug available.

    Too little too late

    Last night. a leading consultant psychiatrist who was among the first to question the safety of Seroxat, said the publication of the Glaxo-funded Seroxat studies was too little, too late.

    Dr David Healy, of the University of North Wales, said: "If the data had been out there from the start, we could have avoided some of the problems we have seen with Seroxat.

    "If people had been aware of the evidence from the trials and seen the risks, they could have reduced the risks of adverse events happening. Parents could have been told to keep a closer eye on their children."

    The nine studies were made available to the Government's regulators, the Medicines and Healthcare Products Regulatory Authority, only in May last year.

    The details lay behind the decision to ban doctors from prescribing Seroxat to under-18s. A spokesman for GlaxoSmith Kline last night said it had already communicated the trials data to the medical community in the normal way through meetings, letters and papers over the last decade.

    Medical regulators

    Medical regulators were also given the data as soon as the risk of suicidal thoughts became clear.

    But he added: "We thought in the interest of transparency and given the interest in this area that we would publish all the documents on the website.

    "We have made no attempt to hide results or mislead regulators or the medical community. Studies individually show no consistent evidence of a problem in terms of the safety issue.

    "It really was not until the nine studies had been completed and we had combined it with further review in 2003 that we saw there was a potential signal."
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    About lsyorke

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  3. by   susanna
    Good article. This surprises me that Paxil was being used to treat only depression though. I was prescribed Paxil for anxiety and depression: the anxiety was relieved but I felt more depressed and my psychiatrist said that this was common. I also know other people who were prescribed it for anxiety and depression but who remained depressed. It thought that it was a drug used mostly for controlling anxiety.

    Sometimes I get miffed by the wording used around suicide. The way people word makes it seem as if a drug can cause suicidal thoughts. But I think, to be more specific, one would say, the drug causes the anxiety/depression/other symptom that leads up to sucide/suicidal thoughts. I guess its the same difference but I feel that the latter is more repectful: I dont know why.
  4. by   Blackcat99
    I'm sorry to hear that paxil does not work well with children. I am wondering if these children were suicidal before starting the paxil?
    I have been taking paxil for the past 2 months and I am feeling less depressed
    and am doing much better now.
  5. by   lsyorke
    " I'm sorry to hear that paxil does not work well with children. I am wondering if these children were suicidal before starting the paxil?"

    My son was never suicidal until he started taking paxil. Be very careful with this drug! My son was fine for the 1st 6 months and then we started to see the aggression, death obsession,not caring about anything attitude. Then add to all this the 2 suicide attempts while weaning off, luckily not successful.The weaning process to come off paxil is awful. It took us 12 weeks to wean him off. Electrical type brain zaps, nausea,dizziness,anger, aggression happened with each wean and took 3 weeks to stabilize. I'm now happy to report he's off paxil and doing wonderful!! Full of life again, sense of humor is back, out with friends. These problems are not only seen in children. Its estimated that 20% of paxil users with have a protracted withdrawal. New information is coming out everyday about the SSRI's. Very scary stuff!!
  6. by   Blackcat99
    Wow! That's awful! Your son had 2 suicide attempts after taking paxil for 6 months! Yikes that is scary! I am so glad to hear that your son is doing much better now. Hmmm... maybe I better think about getting off paxil too! :uhoh21:
  7. by   lsyorke
    Check out this website. Its for those who are getting off Paxil. It might give you a little insight from those who have been on Paxil.I'm not trying to scare you, just give you another side of the story.
  8. by   Blackcat99
    Quote from lsyorke
    Check out this website. Its for those who are getting off Paxil. It might give you a little insight from those who have been on Paxil.I'm not trying to scare you, just give you another side of the story.
    Wow! That is scary! It's a great site! I think I'm going to start weaning myself off my Paxil. Thanks
  9. by   lsyorke
    It was paxilprogress that saved my sons life.You can read his whole thread in the family support section under Teenager/post traumatic stress/paxil. My son was dropped by his psychiatrist after the suicide attempts.He didn't want him back as a patient because his drug screen showed pot. We have now discovered that pot use in paxil use is very common because is calms the akasthesia(constant restlessness). It amazes me that an adolescent psychiatrist would do this. We have never heard from him again.
    Its a shame I had to find a Canadian message board to get information that saved my sons life.But thank God I did or he would probably be dead by now. Good Luck in weaning! You should tell whoever prescribed the Paxil that you want to wean off. Weaning off very slow is the only way to go to minimize the withdrawal effects.Paxilprogress is a VERY supportive group of people who have gone through it and can offer advice or just be there to listen.
  10. by   CliveUK
    lsyorke - my best wishes to Ry and yourself now that the bad days are behind you. I read your thread and what a story that is! Good luck to you both for the future.
  11. by   lsyorke
    Thanks Clive UK!! As you can tell by that thread, its was quite a roller coaster ride. Your country is soooo far ahead of the U.S. in banning SSRI's in teenagers. Hopefully our activism will have the same done here soon. Until that time I will continue to beat the drum to warn other parents!!
  12. by   finness
    there have been a lot of "attacks" on ssri's lately--paxil in particular. true, the "weaning off process" is certainly no picnic. (i forgot to take it three days in a row and almost yacked because the ceiling was spinning!) however, ask one of us who suffered from severe anxiety and took refuge with this drug, and we will most likely tell you that chronic panic attacks aren't any more enjoyable. yuck--hand me the temporary--albeit uncomfortable--withdraw any day. that said, statistics still indicate that for every person paxil has caused harm, it has liberated many others. after all, every drug is not for every person. in fact, i can't take painkillers because i have a sensitive stomach. the nausea it causes me is much worse then the original pain; it's all a matter of personal choice. i am all for patient education, but legislation that demonizes a drug that has been a blessing for so many? that's a "nay" from this end of the table. i could be wrong here, and please correct me if i am, but getting to the point where one experiences withdraw because he/she doesn't need the medication anymore...isn't that a success in itself?
  13. by   lsyorke
    Taking Paxil or not is your own personal choice. The fact that is was never FDA approved for under age 18, that is was first proclaimed to be "non habit forming", that the clinical trials where hidden until recently that showed the effectiveness is teenagers was the same as a placebo, that the increased risk of suicide was hidden(7% hostility with paxil vs 0 with placebo, 6 suicide attempts in one study for those getting paxil vs. 1 on placebo)from the public, that 20% of Paxil users will have a "protracted withdrawal".

    Like I said its your choice to use Paxil or not. That being said by the description of your symptoms you have made a decision to use this drug for life.SSRI's do not "cure" you of anxiety(it was never approved for use in anxiety, only depression).That you must discover within yourself.I wish you well in your search for mental health and hope you never have to experience what my son, my neighbors daughter, and a good friends daughter have had to go through!

    To comment on " could be wrong here, and please correct me if I am, but getting to the point where one experiences withdraw because he/she doesn't need the medication anymore...isn't that a success in itself?" I weaned my son off of Paxil because it had over a year turned him into a hostile,angry, death obsessed teenager who didn't care if he lived or died.Now that he's off he's a well adjusted kid, no anxiety, no depression. I just wish I had the knowledge I've aquired over the past 6 months a year ago so my son wouldn't have had to go through this hell. Seratonin levels being altered artificially can cause all these symptoms.

    Since the seratonin levels are never tested prior to SSRI administration, just how do you know where you were to begin with?? Do you need more or less??

    Good Luck
  14. by   finness
    as i said, i am pro patient education. i have never, and i do mean never, condoned the fda's actions at suppressing information about paxil's clinical trials--especially if that information shows that the drug is contraindicated (or worse) in teenagers with depression. my heart goes out to those who suffered at the hands of pharmaceutical companies and physicians who were reckless and misinformed. the statistics that you provided indicate that there is surely some link between severe depression or mood disorders and suicide in conjunction with teenager paxil-users. furthermore nobody would dispute that ssri's have a terrible withdraw period. whether or not you want to let that overshadow the stellar accomplishments of this drug in other arenas is completely up to you. per those 6 tragic suicides, there were 154 lives that significantly benefited from this drug. while that in no way minimizes the loss of such young lives, it does speak of the effectiveness of paxil to treat depression. thank you for your "concern" lysorke, but i've not been "cured" of my anxiety; rather, i am now able to control my symptoms in a way that lets me go about my daily life without having an anxiety attack. (and yes, this ssri in particular was not only approved for panic disorder but proved effective in treating generalized anxiety in "most" adults. per the ams, "the u.s. food and drug administration has approved paxil cr for the treatment of major depressive disorder and panic disorder. in national studies paxil cr has proven useful in the treatment of generalized anxiety." if you don't mind, lysorke, i would like to know where you got your information! if my physician prescribed me the wrong medication...i would like to know. you do make a good point, though. i bet a good percent of the people who wean off paxil are those who are experiencing adverse reactions. congratulations to your son for conquering the terrible withdrawal process. as for me, while i have not made a decision to "stay on this medication for life", i do not anticipate tapering anytime soon. i am still in amazement at how much i am able to accomplish thanks to this medication....