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| Warning about ZYPREXA (olanzapine) (May 2004) |
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Now a warning about the drug ZYPREXA
(olanzapine), made by Eli Lilly and company.
ZYPREXA is used to treat schizophrenia and
bipolar disorder.
The WARNINGS section of the drug's label now
describes cerebrovascular adverse events.
These have occurred in elderly patients being
treated for dementia-related psychosis in
clinical trials. These events, some of them
fatal, have included stroke and TIAs. The
labeling reminds practitioners that ZYPREXA
has not been approved for the treatment of
patients with dementia-related psychosis.
Tags : Zyprexa Warning FDA Schizophrenia Bipolar Disorder Stroke Patient Safety Drug Reaction |
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Affichage : 3011
Durée : 40 s |
| Zyprexa Drug Rep |
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PharmedOut, a new project that educates
physicians on how pharmaceutical companies
influence prescribing, is previewing a timely
video about Zyprexa (olanzapine), an
antipsychotic drug approved by the FDA to
treat
schizophrenia and bipolar disorder. In this
video Shahram Ahari, a former pharmaceutical
company representative, tells how he sold the
drug. Nearly a decade after its introduction,
a drug once hailed as a breakthrough
treatment is being assailed for its negative
side effects.
Antipsychotic drugs are not risk-free, but
doctors and patients have long complained
that Zyprexa causes obesity and diabetes.
This week, the New York Times reported that
studies on the frequency of weight gain were
underreported by the manufacturer. PharmedOut
is an independent
physician-run project funded through the
Attorney General Consumer and Prescriber
Education grant program.
Tags : PharmedOut olanzapine schizophrenia bipolar antiphsychotic drugs eli lilly side effects obesity diabetes |
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Affichage : 86844
Durée : 325 s |
| Alert on Atypical Antipsychotics (June 2005) |
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FDA has issued an alert about increased
mortality when using "atypical" antipsychotic
drugs to treat behavioral disorders in
elderly patients with dementia. The alert
applies to drugs such as Abilify
(aripiprazole), Zyprexa (olanzapine),
Seroquel (quetiapine), Risperdal
(risperidone), Clozaril (clozapine) and
Geodon (ziprasidone). Symbyax (olanzapine and
fluoxetine HCl), an antidepressant, is also
covered by the advisory.
These drugs are not approved for treating
behavioral disorders in patients with
dementia. In fact, they're approved only for
treating schizophrenia and mania. So this
constitutes an unapproved, "off-label" use.
The situation came to light when these drugs
were being tested in clinical trials on
elderly patients with dementia. Those treated
with the drugs had a higher mortality rate
than those receiving placebo. The causes of
death were varied, but most of them appeared
to be either cardiovascular or due to
infection, such as pneumonia.
FDA has asked the manufacturers of these
drugs to add a boxed warning to the labeling
describing the increased mortality risk. The
labeling will also state that these drugs are
not approved for treating behavioral symptoms
in elderly patients with dementia.
FDA is also considering adding a warning to
the labeling of older antipsychotic
medications, because limited data suggest
that there may be a similar increase in
mortality for these drugs.
Tags : Atypical Antipsychotics FDA Dementia Abilify Zyprexa Seroquel Risperdal Clozaril Geodon Symbyax Schizophrenia Safety |
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Affichage : 2640
Durée : 104 s |
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