INdiana Systemic Thinking

February 5, 2008

More Trouble for Zyprexa

In what is becoming more and more common, Eli Lilly’s Schizophrenia drug Zyprexa has run into a little more trouble.  From the Reuters, via the Indianapolis Star:

Excessive sedation is a “serious safety concern” with an experimental, long-acting form of Eli Lilly and Co.’s blockbuster Zyprexa schizophrenia medicine, U.S. drug reviewers said in an analysis released Monday.

Food and Drug Administration staff said the injectable formulation, called Zyprexa Adhera, was shown to be effective for acute and long-term treatment of schizophrenia, Reuters and Bloomberg both reported.

But risks include excessive sleepiness.

The analysis was released ahead of a meeting by a panel of outside advisers who will evaluate the drug Wednesday.”Excessive sedation events are a serious safety concern because of the severity of excessive sedation, the unpredictable characteristics, and relatively high incidence – 0.07% of injections and 1.3% of patients,” FDA staff said.

Lilly officials, in a separate summary, said they thought the benefits of the long-acting formulation outweighed the risks.

“Although there are important additional safety considerations associated with the injection, they are manageable with appropriate labeling and risk-minimization activities,” the company said, Reuters reported.

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18 Comments »

  1. If someone were to state Mental illness does not exist, all one would have to do in order acquire a meager concept of Mental Illness would be to take a cursory look at THE GROUPs associated with inventing such mental illnesses (i.e. its sources). That is an extremely bold statement to make. “…inventing mental illnesses.”. I suppose this argument presents the paradox of the all too common question of “did the egg come before the chicken?”, or “did the Psychiatrist come before the mental illness?”.

    Why would someone like me or millions of others even begin to imply such a blithe notion that Mental Illness is invented by a group of charlatans? After all, people do have rough days, drink excessively and sometimes feel nervous speaking in front of audiences. Adults can also, not even mentioning children, have a bit of difficult time sitting still, in hard wooden or plastic chairs, and concentrating for extended periods of time. After all, couldn’t the entire sum of human responses or emotional difficulties be categories as mental illness. (e.g. recently purported jet lag is a mental illness and can be addressed with medication). Since the mental health experts are only able to diagnose and adjudicate a patient’s mental stability based solely on subjective intuition, where unfortunately lacking a clear-cut blood or forensic test. Couldn’t any and all abnormality (besides of course physically in nature) be classified and/or categorized as a mental health problem (e.g. picking of nose, road rage, excessive surfing of the internet, etc.)?

    Without a doubt, no one would argue that any eccentricity in human behavior found could be classified, codified and categorized as a mental health illness. Perhaps because (as reported) mental illness is way too complicated of a subject, is it too much to ask for accurate causes thus leading to such a diagnosis and medication? – meaning, hypothetically; who wouldn’t demand answers from their car mechanic explaining the cause and source of their engine problems, let alone ongoing visits (2-5 visits weekly) to get the same engine tuned or adjusted? Personally, I would want some answers.

    What about all the millions of people who have supposedly been assisted by the myriad of FDA rated Class II anti-psychotics/depressants drugs currently on the market (compared by many experts and the FDA to have similar side effects and as addictive as heroin)? How could one deny that people actually feel and operate better on these high powered narcotics? After all, it doesn’t take a genius to see that Johnny is now able to sit still in those hard plastic/wooden chairs in class, and that Betty is certainly able to attended social gatherings without eating up her insides.

    Do these drugs change the way we feel?

    What’s wrong with the way we feel and who is saying it? Can the root (Psychiatry, Pharmaceutical, DSM, etc.) of all these dreaded mental disorders cure the actual cause(s) of what’s wrong with people in society, or are we going further down a road with more classifications, more people (children too) entwined in chemical straitjackets, addicted to medication (thus turning a profit) and a whole new brave world where everyone on the street has some “disorder” that can be cured with a magic little pill? In ten years from now, will the topics of conversation be “What disorder do you have and what are you taking for it?” Hasn’t a patterns been forming here where the Pharmaceutical companies have been engaging in putting the illicit drug lords out of business? Who wouldn’t want some of the cheddar?

    Not only do we have synthetic mental disorders being created; we now have Eli Lilly generating more business in the form of unnatural creation of diabetes.
    See: http://www.cchr.org

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