FDA Cannot Find Conclusive Evidence Zyprexa Injection Killed Patients

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After an investigation, the US Food and Drug Administration has stated that they are still unsure whether the long-acting, injectable antipsychotic drug Zyprexa Relprevv (olanzapine pamoate) killed two people who died within several days of receiving the injection, according to an FDA press release.

Zyprexa is an antipsychotic often given to people diagnosed with schizophrenia, or to control behaviors in people with dementia. In recent years, long-acting injectable forms of antipsychotics are being more commonly given to people who are forgetful, “non-adherent” or resistant to taking psychiatric drugs.

“This is not the first time [the drug manufacturer] Lilly has faced safety issues tied to its Zyprexa franchise,” reported FiercePharma. “Zyprexa Relprevv’s label warns of the risk of ‘post-injection delirium sedation syndrome,’ which is caused when the drug enters the blood too quickly.”

“The study results were inconclusive,” stated the FDA press release. “The study suggested that much of the drug level increase could have occurred after death, a finding that could explain the extremely high blood levels found in the two patients who died 3 to 4 days after receiving injections of appropriate doses of Zyprexa Relprevv.”

Zyprexa Relprevv (olanzapine pamoate): Drug Safety Communication – FDA Review of Study Sheds Light on Two Deaths Associated with the Injectable Schizophrenia Drug (FDA press release, March 23, 2015)

FDA lets Lilly’s long-acting Zyprexa off the hook in patient deaths (FiercePharma, March 24, 2015)

14 COMMENTS

  1. And they can’t apparently rule it out, because there was no other cause. Ok. Most likely they just don’t want to be the ones to say they’ve fraudulently claimed drugs are safe, and that people are getting hurt by them.

    Most studies show people get severe disability from the drugs, and severe tardive syndromes.

    The AMA’s own study shows 100,000’s die from properly prescribed drugs a year.

    People are apparently dying younger because of psych drugs.

    Severe illnesses and sicknesses are induced.

    This goes with the fact that there’s no record of these drugs being “safe,” “effective,” “boosting IQ” and “improving functionally” to the point of being measurable like a demonstration on how the individual is making more profits and holding down a job they were never able to hold before.

    http://www.drrobertduncan.com/

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  2. “The study suggested that much of the drug level increase could have occurred after death, a finding that could explain the extremely high blood levels found in the two patients who died 3 to 4 days after receiving injections of appropriate doses of Zyprexa Relprevv.”

    Looks like a classic case of “begging the question”, a philosophical term that essentially means circular reasoning. We are asked to believe out of hand a couple of things that should properly be considered as critical questions of this investigation: 1) that there was no actual error in the dosage administered; 2) the dosages deemed appropriate are, in fact, not toxic for SOME people (since it is abundantly clear that different people can react very differently to the same medication/dosage).

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    • “… it is abundantly clear that different people can react very differently to the same medication/dosage,” is absolutely true.

      It’s even possible for a grown adult to be made psychotic within two weeks of being put on a child’s dose of a neuroleptic. From drugs.com: “neuroleptics … may result in … the anticholinergic intoxication syndrome … Central symptoms may include memory loss, disorientation, incoherence, hallucinations, psychosis, delirium, hyperactivity, twitching or jerking movements, stereotypy, and seizures.”

      One must wonder how often the central symptoms of neuroleptic induced anticholinergic intoxication syndrome are misdiagnosed as one of the major mental illnesses, since the symptoms are almost exactly the same.

      I’m sure Lilly will confess their long-acting, injectable antipsychotic drug Zyprexa Relprevv is not a “wonder drug,” once the patents expire. One must question the honesty and efficacy of the FDA, however.

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  3. I wonder how many similar cases have been buried because “adverse events” with drugs are not properly reported? Psychiatric diagnoses are very convenient “wild cards” that serve to deflect honest, scientific analysis of the use of medication or other treatments. Keep in mind that these diagnoses have no objective basis in terms of blood tests, MRI’s, or any other definitive medical measures. I have seen how this works in practice, up close and personal. Rather than recognize a clearly adverse drug reaction, psychiatric practitioners refer to “the episodic nature of the illness”. And of course they want to have their cake and eat it too, so that if one uses this “episodic nature of the illness” to argue for giving the person in a crises state time to recover, with support other than drugs or electroshock, they are then all about the “evidence base” in favor of their drugs and ECT–an “evidence base” that conveniently ignores long-term studies and other evidence that does support their reductionist biopsychiatric orientation (i.e., religious conviction).

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    • oops…left out one critical word that totally changes what I was trying to say:

      “an ‘evidence base’ that conveniently ignores long-term studies and other evidence that does NOT [left out] support their reductionist biopsychiatric orientation (i.e., religious conviction).”

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    • Injectable long-acting Zyprexa, it must have been hatched in the same corner of hell as Thalidomide.

      I have read alot of negative things about psychiatric drugs in my years doing this and with Zyprexa / Olanzapine people almost always use words hell evil and devil to describe it cause that’s what it is.

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  4. This is not the first time the FDA let Lilly off the hook for Zyprexa. Back in 2003, after Japan had already required Lilly to post a warning in that country (April, 2002) for diabetes, hyperglycemia, and death, and after front page stories in the Baltimore Sun, Wall Street Journal, and New York Times, for these very deaths from Zyprexa, the FDA made ALL the makers of the atypical antipsychotics place a warning on them – even though it was Zyprexa that was the culprit.
    Lilly seems to live a charmed life when it comes to this lethal drug.

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  5. Regarding “I wonder how many similar cases have been buried?”
    I read health services blogs. I remember one case where the “psychotic” guy kept getting injected with antipsychotics, to fight the no-existent psychotic molecule.
    The health service worker, killed his patient with a clear conscious. The patient died of “excited delirium”.

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