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  1. wellhelm
    FDA warning - "misleading" material regarding Seroquel


    [​IMG]The U.S. Food and Drug Administration (FDA) has issued a letter to AstraZeneca, the manufacturer of Seroquel (quetiapine fumarate) stating that a piece of promotional material for Seroquel tablets is false or misleading and requesting that AstraZeneca "immediately cease the dissemination of violative promotional materials for Seroquel." According to the letter,
    "This piece is false or misleading because it minimizes the risk of hyperglycemia and diabetes mellitus and fails to communicate important information regarding neuroleptic malignant syndrome, tardive dyskinesia, and the bolded cataracts precaution ... The promotional material raises significant public health and safety concerns through its minimization of the risks associated with Seroquel."​
    Seroquel is an atypical antipsychotic medication that is FDA approved for the treatment of acute manic episodes associated with bipolar disorder and for the treatment of schizophrenia. It is sometimes prescribed off-label for headache and migraine prevention.


    In 2003, following review of the data available regarding the use of atypical antipsychotic medications and diabetes adverse events, the FDA asked the manufacturers of these medications to include a warning in their patient information regarding the risk. AstraZeneca complied with that request. In question is information now being presented in promotional materials for Seroquel. AstraZeneca has until November 30 to comply with the conditions set forth in this warning letter.

    For more information about Seroquel, see Seroquel / Quetiapine Medication Profile

    Swim is perscribed this and is always concerned about side effect's. He has recently quit depakote because of the horrible effect's it can have on the liver, not to mention the constant sedated feeling(no, its no rereational). Swim plans on quiting seroquel next week, becuase of the side effects, as soon as he gets his sleep herbs.

    This was taken from another article almost identical except for this.....

    Seroquel, which had global sales of $2.76 billion last year, is indicated for the treatment of schizophrenia and bipolar disorder.

    http://today.reuters.com/news/artic..._L27846635_RTRIDST_0_ASTRAZENECA-SEROQUEL.XML

Comments

  1. angeliclight
    Re: Seroquel maker's minimize risks

    The thing that is really upsetting is that people think these drugs are a new way to get high. Your post is good. Please see my post in Paraclesus's thread Are Antidepressents good for a Boost? I hope that people who are considering using psychiatric meds read about the many I've listed AND their extensive and dangerous side effects. Take care.
  2. Nagognog2
    Re: Seroquel maker's minimize risks

    I don't know if this was covered elsewhere, but the makers of seroquel are facing a massive class-action lawsuit presently. There have been advertisements on TV all across the nation (USA) asking people who took it and suffered various (quite a few) side-effects to call their toll-free number and sign on. Astra-Zeneca is going to get screwed but good.

    A friend of mine was nearly killed from that gunk. If you have seroquel - find that lawsuit on the net. And flush 'em down the commode.
  3. Micklemouse
    Re: Seroquel maker's minimize risks

    A quick Scroogle shows that virtually every lawyer in the country is going after this one, as well as Olanzepine & Risperidone. Should be fun!
  4. darkglobe
    Re: Seroquel maker's minimize risks

    FUN?

    Is this similar to the Seroxat episode of yesteryear?
    SWIM is on Fluoxetine... is this also bad?

    ~Dark
  5. Zaprenz
    Re: Seroquel maker's minimize risks

    I would imagine the evidence surrounding patients having problems on Seroquel might get very subjective.

    Seeing as schizophrenia is such a complex illness. Same as the "was it the constant LSD or underlying schizophrenia that caused the schizophrenic episode arguement". The same I would imagine could be used "was it the seroquel or the underlying mental disorder that made him flip". :eek:
  6. Nagognog2
    Re: Seroquel maker's minimize risks

    This is why it's rare to hear of a successful lawsuit brought against a psychiatrist - they claim you're a poor, sick child suffering terrible delusions. Like one I knew who kept a harem of teenage girls virtual prisoners in his house as sex-slaves.

    Same goes for trying to sue a pharma. company: You took their drugs because you're crazy. Therefore you are hallucinating the side-effects.
  7. wellhelm
    Re: Seroquel maker's minimize risks

    I know you guys know but it is also used a lot for off lable use's. Insomnia and anxiety disorder's are probably the most common. Its given to people with borederline personality disorder as well and I do not know how much it would matter if someone was schizo or not when with out any personal or family history of these physical symtoms prior to taking Seroquel then suddenly devlopes them after words. You can't be delusional about diabetes. You either have it or you don't. I don't think schizo would matter. Isn't that what the law suit is about? I might be worng but thats what I thought.
  8. Micklemouse
    Re: Seroquel maker's minimize risks

    The lawsuits are concentrating on the physical effects of long term use - diabetes, weight gain, cardiac problems etc. For more info see here

    http://www.drugs-forum.com/forum/showthread.php?t=29535
  9. wellhelm
    Re: Seroquel maker's minimize risks

    Swim gained 40 fucking pounds on Seroquel and gained it QUICK with out any question that it was infact Seroquel. Having been 175 for years prior to joining the military. 175 for 4 years in the military. Taking Seroquel 6 months after discharge and going up to 215. The whole time still exerciseing. For swim it raised his appetite to infinit proportions. Never feeling full. Been off it quite sometime now and his weight has dropped to 185-190. Still dropping to.
  10. Zaprenz
    Re: Seroquel maker's minimize risks

    Weight gain is another very subjective thing. Was it the lack of sleep (when used for sleeping), constant anxiety or any other underlying condition that caused the weight gain or was it seroquel?

    Btw I'm not backing seroquel, just am very glad I'm not having to try and compare the evidence, must be quite hard to make the right call.
  11. Mindless
    ^^ Rather a late reply this, I'm going through some old threads. There is also a related thread here, on antipsychotics and weight gain. A weight gain of more than 7% in body weight in around 1 in 3 users is found in some studies. Source: Antipsychotic Comparison Chart. Brent Jensen 2003.

    Pharmaceutical companies frequently misrepresent the facts about their products, either to make inflated claims about clinical efficacy, or to draw attention away from adverse effects. This is demonstrated well in the link provided by Micklemouse, on Olanzipine, Risperidone, Quetiapine, lawsuits.
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