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FDA Wants Suicide Warning Labels on Antidepressants

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General fitness, health and nutrition
Published
22 March 2004
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26 March 2004
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Psi
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  1. FDA Wants Suicide Warning Labels on Antidepressants

    Monday, March 22, 2004

    WASHINGTON — Patients on some popular antidepressants should
    be closely monitored for warning signs of suicide, the
    government warned Monday in asking the makers of 10 drugs to
    add the caution to their labels.

    Although the Food and Drug Administration's investigation
    into the possible suicide connection initially focused on
    children given the drugs, its warning is aimed at both adult
    and pediatric use.

    It isn't clear yet that the drugs actually do lead to
    suicide, the FDA stressed. But until that is settled,
    advisers to the FDA called last month for stronger warnings
    to doctors and parents that the antidepressants may cause
    agitation, anxiety and hostility in a subset of patients who
    may be unusually prone to rare side effects.

    On Monday, the FDA followed its advisers' recommendation and
    issued a public health advisory putting doctors, patients,
    families and other caregivers on notice to be particularly
    vigilant for signs of worsening depression or suicidal
    thoughts at the beginning of anti-depressant therapy or
    whenever the dose is changed.

    The drugs of concern are all newer-generation
    antidepressants: Prozac, Paxil, Zoloft, Effexor, Celexa,
    Remeron, Lexapro, Luvox, Serzone and Wellbutrin. Most are
    known to affect the brain chemical serotonin

    British health authorities sounded the alarm last year,
    saying long-suppressed research suggests certain
    antidepressants might sometimes increase the risk of
    suicidal behavior in children and teenagers.

    Because only one drug, Prozac, has been proven to alleviate
    pediatric depression, Britain declared others — drugs called
    selective seretonin reuptake inhibitors (SSRIs) and their
    close relatives — unsuitable for depressed youth.

    The FDA issued a caution on pediatric use last year, but
    Monday's action — especially the addition of the warning to
    drug labels — goes significantly further.

    Dozens of anguished parents pleaded with FDA in a meeting
    last month to add such warnings, citing preteens and
    teenagers who hanged themselves or slashed their wrists
    shortly after starting the antidepressants.

    Parent after parent described children who had become
    extremely agitated or anxious shortly after starting the
    antidepressants, and seemingly sudden impulses that
    turned deadly.

    foxnews.com0,2933,114841,00.html

    --

    "For oral administration, to adults only. Children: Not recommended."
    Prozac (Fluoxetine) 'Abbreviated Prescribing Information', Eli Lilly &
    Co.

    "[T]he only drug that has received approval for use in children with
    major depressive disorder is fluoxetine (Prozac)." FDA Talk Paper,
    Public Health Advisory on Cautions for Use of Antidepressants in
    Adults and Children. Mar 22 04.

    groups.msn.compsychbusters
    Decoding Psychiatric Propaganda

  2. There is another consideration in all this. People who work
    with severely depressed people have a saying that after the
    introduction of meds Suicide is more likely because those
    who are so inclined will have the emotional energy to do
    something about it. For someone really in a down period,
    even to go through the preperation for the act is
    impossible, even when there is considerable thought given to
    it. With meds there is enough inprovement to act.

    Quoted message said:

    FDA Wants Suicide Warning Labels on Antidepressants

    Monday, March 22, 2004

    WASHINGTON Patients on some popular antidepressants should
    be closely monitored for warning signs of suicide, the
    government warned Monday in asking the makers of 10 drugs
    to add the caution to their labels.

    Although the Food and Drug Administration's investigation
    into the possible suicide connection initially focused on
    children given the drugs, its warning is aimed at both
    adult and pediatric use.

    It isn't clear yet that the drugs actually do lead to
    suicide, the FDA stressed. But until that is settled,
    advisers to the FDA called last month for stronger warnings
    to doctors and parents that the antidepressants may cause
    agitation, anxiety and hostility in a subset of patients
    who may be unusually prone to rare side effects.

    On Monday, the FDA followed its advisers' recommendation
    and issued a public health advisory putting doctors,
    patients, families and other caregivers on notice to be
    particularly vigilant for signs of worsening depression or
    suicidal thoughts at the beginning of anti-depressant
    therapy or whenever the dose is changed.

    The drugs of concern are all newer-generation
    antidepressants: Prozac, Paxil, Zoloft, Effexor, Celexa,
    Remeron, Lexapro, Luvox, Serzone and Wellbutrin. Most are
    known to affect the brain chemical serotonin

    British health authorities sounded the alarm last year,
    saying long-suppressed research suggests certain
    antidepressants might sometimes increase the risk of
    suicidal behavior in children and teenagers.

    Because only one drug, Prozac, has been proven to alleviate
    pediatric depression, Britain declared others drugs called
    selective seretonin reuptake inhibitors (SSRIs) and their
    close relatives unsuitable for depressed youth.

    The FDA issued a caution on pediatric use last year, but
    Monday's action especially the addition of the warning to
    drug labels goes significantly further.

    Dozens of anguished parents pleaded with FDA in a meeting
    last month to add such warnings, citing preteens and
    teenagers who hanged themselves or slashed their wrists
    shortly after starting the antidepressants.

    Parent after parent described children who had become
    extremely agitated or anxious shortly after starting the
    antidepressants, and seemingly sudden impulses that
    turned deadly.

    foxnews.com0,2933,114841,00.html

    --

    "For oral administration, to adults only. Children: Not
    recommended." Prozac (Fluoxetine) 'Abbreviated Prescribing
    Information', Eli Lilly &
    Co.

    "[T]he only drug that has received approval for use in
    children with major depressive disorder is fluoxetine
    (Prozac)." FDA Talk Paper, Public Health Advisory on
    Cautions for Use of Antidepressants in Adults and Children.
    Mar 22 04.

    groups.msn.compsychbusters Decoding Psychiatric
    Propaganda

  3. <[email hidden]> wrote in message
    "]news:[email hidden]...

    Quoted message said:


    There is another consideration in all this. People who
    work with severely depressed people have a saying that
    after the introduction of meds Suicide is more likely
    because those who are so inclined will have the emotional
    energy to do something about it. For someone really in a
    down period, even to go through the preperation for the
    act is impossible, even when there is considerable thought
    given to it. With meds there is enough inprovement to act.

    Possibly. Or quite possibly it's just that a fair percentage
    of depressed people do commit suicide (around 15% IIRC), so
    it's not too surprising that some do it after starting a new
    medication.

    Quoted message said:
    Quoted message said:

    FDA Wants Suicide Warning Labels on Antidepressants

    Monday, March 22, 2004

    WASHINGTON Patients on some popular antidepressants
    should be closely monitored for warning signs of suicide,
    the government warned Monday in asking the makers of 10
    drugs to add the caution to their labels.

    Although the Food and Drug Administration's investigation
    into the possible suicide connection initially focused on
    children given the drugs, its warning is aimed at both
    adult and pediatric use.

    It isn't clear yet that the drugs actually do lead to
    suicide, the FDA stressed. But until that is settled,
    advisers to the FDA called last month for stronger
    warnings to doctors and parents that the antidepressants
    may cause agitation, anxiety and hostility in a subset of
    patients who may be unusually prone to rare side effects.

    On Monday, the FDA followed its advisers' recommendation
    and issued a public health advisory putting doctors,
    patients, families and other caregivers on notice to be
    particularly vigilant for signs of worsening depression
    or suicidal thoughts at the beginning of anti-depressant
    therapy or whenever the dose is changed.

    The drugs of concern are all newer-generation
    antidepressants: Prozac, Paxil, Zoloft, Effexor, Celexa,
    Remeron, Lexapro, Luvox, Serzone and Wellbutrin. Most are
    known to affect the brain chemical serotonin

    British health authorities sounded the alarm last year,
    saying long-suppressed research suggests certain
    antidepressants might sometimes increase the risk of
    suicidal behavior in children and teenagers.

    Because only one drug, Prozac, has been proven to
    alleviate pediatric depression, Britain declared others
    drugs called selective seretonin reuptake inhibitors
    (SSRIs) and their close relatives unsuitable for
    depressed youth.

    The FDA issued a caution on pediatric use last year, but
    Monday's action especially the addition of the warning to
    drug labels goes significantly further.

    Dozens of anguished parents pleaded with FDA in a meeting
    last month to add such warnings, citing preteens and
    teenagers who hanged themselves or slashed their wrists
    shortly after starting the antidepressants.

    Parent after parent described children who had become
    extremely agitated or anxious shortly after starting the
    antidepressants, and seemingly sudden impulses that
    turned deadly.

    foxnews.com0,2933,114841,00.html

    --

    "For oral administration, to adults only. Children: Not
    recommended." Prozac (Fluoxetine) 'Abbreviated
    Prescribing Information', Eli Lilly &
    Co.

    "[T]he only drug that has received approval for use in
    children with major depressive disorder is fluoxetine
    (Prozac)." FDA Talk Paper, Public Health Advisory on
    Cautions for Use of Antidepressants in Adults and
    Children. Mar 22 04.

    groups.msn.compsychbusters Decoding Psychiatric
    Propaganda

  4. Dr. Zarkov said:

    Possibly. Or quite possibly it's just that a fair
    percentage of depressed people do commit suicide (around
    15% IIRC), so it's not too surprising that some do it
    after starting a new medication.

    Yes, exactly!

    Data from Australian suicide stats in men, show that there
    has been a significant drop in suicide rates in middle-aged
    and elderly men over the last 10-12 years, with a
    corresponding increase in antidepressant use (3 fold
    increase between 1989 and 1999).

    Sadly, the suicide rate in young men (under 25) went up over
    the same period. However, their diagnosis was more likely to
    be schizophrenia and/or drug abuse, rather than primarily
    depression.

    Larry Brash

  5. "Dr. Zarkov" <[email hidden]> wrote in message news:<[email hidden]>...

    Quoted message said:

    <[email hidden]> wrote in message -"]news:[email hidden]-
    net.com...

    Quoted message said:


    There is another consideration in all this. People who
    work with severely depressed people have a saying that
    after the introduction of meds Suicide is more likely
    because those who are so inclined will have the
    emotional energy to do something about it. For someone
    really in a down period, even to go through the
    preperation for the act is impossible, even when there
    is considerable thought given to it. With meds there is
    enough inprovement to act.

    Possibly. Or quite possibly it's just that a fair
    percentage of depressed people do commit suicide (around
    15% IIRC), so it's not too surprising that some do it
    after starting a new medication.

    Actually there is a huge percent of depressed people that
    are not suicidal, just depressed. There is a difference you
    know. And there have been too many instances of depressed
    people going on these medications and then becoming suicidal
    AND/OR homocidal.

    TC

  6. In article<[email hidden]>, tcomeau

    Quoted message said:

    "Dr. Zarkov" <[email hidden]> wrote in message
    news:<405f81f9$0$3042$61f [email hidden]>...

    Quoted message said:

    <[email hidden]> wrote in message -"]news:[email hidden]-
    net.com...

    Quoted message said:


    There is another consideration in all this. People who
    work with severely depressed people have a saying that
    after the introduction of meds Suicide is more likely
    because those who are so inclined will have the
    emotional energy to do something about it. For someone
    really in a down period, even to go through the
    preperation for the act is impossible, even when there
    is considerable thought given to it. With meds there is
    enough inprovement to act.

    Possibly. Or quite possibly it's just that a fair
    percentage of depressed people do commit suicide (around
    15% IIRC), so it's not too surprising that some do it
    after starting a new medication.

    Actually there is a huge percent of depressed people that
    are not suicidal, just depressed.

    And how would you tell one of these from someone who was
    as yet TOO tired and depressed to contemplate, or
    attempt, suicide?

    --

    ~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~-
    ~~~~~~~~~~
    8====3 (O 0) GROETEN --- PRINTZ XEMU EXTRAWL no real OT
    has |n| (COMMANDER, FIFTH INVADER FORCE) ever existed ...-
    .........................................................-
    ..... A society without a religion is like a maniac
    without a chainsaw.

  7. On Mon, 22 Mar 2004 19:16:24 -0500, "Dr. Zarkov" <[email hidden]>
    posted:

    Quoted message said:

    <[email hidden]> wrote in message -"]news:[email hidden]-
    net.com...

    Quoted message said:


    There is another consideration in all this. People who
    work with severely depressed people have a saying that
    after the introduction of meds Suicide is more likely
    because those who are so inclined will have the emotional
    energy to do something about it. For someone really in a
    down period, even to go through the preperation for the
    act is impossible, even when there is considerable
    thought given to it. With meds there is enough
    inprovement to act.

    Possibly. Or quite possibly it's just that a fair
    percentage of depressed people do commit suicide (around
    15% IIRC), so it's not too surprising that some do it after
    starting a new medication.

    I wonder why? If you are looking for an alternative
    explanation from that above, it would seem odd for a new
    med to trigger suicide. Surely the patient might be more
    likely to wait and see what the longer term effect of the
    new hope might be.

    Granted that a certain percentage of depressed people commit
    suicide, but trying to unravel this into subgroups seems a
    reasonable line of investigation.

  8. On Tue, 23 Mar 2004 23:55:48 +1100, Larry Brash
    <[email hidden]> posted:

    Quoted message said:
    Dr. Zarkov said:

    Possibly. Or quite possibly it's just that a fair
    percentage of depressed people do commit suicide (around
    15% IIRC), so it's not too surprising that some do it
    after starting a new medication.

    Yes, exactly!

    Data from Australian suicide stats in men, show that there
    has been a significant drop in suicide rates in middle-aged
    and elderly men over the last 10-12 years, with a
    corresponding increase in antidepressant use (3 fold
    increase between 1989 and 1999).

    Sadly, the suicide rate in young men (under 25) went up
    over the same period. However, their diagnosis was more
    likely to be schizophrenia and/or drug abuse, rather than
    primarily depression.

    I understood that a lot of these young male suicides were
    from rural

    their city brothers could, and much employment hopelessnes.
    Then they choose an irrevocable method with readily
    available firearms. Females tend to choose revocable methods
    like overdoses and wrist cutting. Many more of them are
    revived with medical attention. Yes, I guess a goodly number
    are schizophrenic. I've actually known two of this ilk. Then
    there are the suicides in vehicles. Often they are not
    recognised as such. And to top off this, there is a news
    embargo on these sad events to avoid copy cat suicides. Many
    aboriginals are involved in Australia.

  9. Here is a statistical rundown from the
    National Institute of Mental Health:

    nimh.nih.govsuifact.cfm

    Squiggles

    --
    Insurance companies are the sole gatekeepers of *the truth*.

  10. On 24 Mar 2004 07:23:18 -0800, [email hidden] (tcomeau) posted:

    Quoted message said:

    "Dr. Zarkov" <[email hidden]> wrote in message
    news:<[email hidden]>...

    Quoted message said:

    <[email hidden]> wrote in message -"]news:[email hidden]-
    net.com...

    Quoted message said:


    There is another consideration in all this. People who
    work with severely depressed people have a saying that
    after the introduction of meds Suicide is more likely
    because those who are so inclined will have the
    emotional energy to do something about it. For someone
    really in a down period, even to go through the
    preperation for the act is impossible, even when there
    is considerable thought given to it. With meds there is
    enough inprovement to act.

    Possibly. Or quite possibly it's just that a fair
    percentage of depressed people do commit suicide (around
    15% IIRC), so it's not too surprising that some do it
    after starting a new medication.

    Actually there is a huge percent of depressed people that
    are not suicidal, just depressed. There is a difference you
    know. And there have been too many instances of depressed
    people going on these medications and then becoming
    suicidal AND/OR homocidal.

    TC

    Which medications? And one person is too many. However, the
    cost benefit analysis shows something different. All drugs
    have small downsides. Even putting on your sox in the
    morning has been known to cause death. You really must learn
    to understand statistics.

  11. "Larry Brash" <[email hidden]> wrote in message
    "]news:[email hidden]...

    Quoted message said:
    Dr. Zarkov said:

    Possibly. Or quite possibly it's just that a fair
    percentage of


    depressed

    Quoted message said:
    Quoted message said:

    people do commit suicide (around 15% IIRC), so it's not
    too surprising


    that

    Quoted message said:
    Quoted message said:

    some do it after starting a new medication.

    Yes, exactly!

    Data from Australian suicide stats in men, show that there
    has been a


    significant drop in

    Quoted message said:

    suicide rates in middle-aged and elderly men over the last
    10-12 years,


    with a

    Quoted message said:

    corresponding increase in antidepressant use (3 fold
    increase between 1989


    and 1999).

    Association only and doesn't sit well with city-rural
    contrast. I don't think there can be any doubt that
    SSRI's help but I suspect that the base rate for
    depression has been factored into the findings; failure
    to do so would constitute a gross analytical error. So I
    would have to accept an increased rate of suicide,
    however slight that may be.

    If more are committing suicide after starting SSRI's perhaps
    the reason is because the patient was made fully aware of
    their extent of their condition. It may be wise for doctors
    not to mention the tissue loss associated with depression,
    or increased heart disease, or the genetic component ... .
    The cause may be some doctors telling their patient bad news
    when that's the last thing they need to hear. Oh yes,
    doctors could try smiling at their depressed patients too
    ... . Happiness is contagious but despair is a plague.

    Quoted message said:

    Sadly, the suicide rate in young men (under 25) went up
    over the same


    period. However,

    Quoted message said:

    their diagnosis was more likely to be schizophrenia and/or
    drug abuse,


    rather than

    Quoted message said:

    primarily depression.

    No, given the massive rural collapse in Australia I think
    depression is the safer option. You don't have to carry
    gene X or predisposing factor Y to experience depression,
    life can do that to you sometimes. While the cities in
    Aus have experienced strong economic growth the rural
    region has declined, I'll opt for the simple answer here
    thanks. Now with rural recovery happening, I expect rural
    suicide to fall.

    Quoted message said:

    Larry Brash

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