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FDA Warns Antipsychotic Drugs Dangerous to Elderly
With Dementia
April 14, 2005 - The Food and Drug Administration
(FDA) this week issued a public health advisory to alert health care
providers, patients, and patient caregivers to new safety information
concerning an unapproved (i.e., off-label) use of certain drugs called
atypical antipsychotic drugs. These drugs are approved for the
treatment of schizophrenia and mania, but clinical studies of these
drugs to treat behavioral disorders in elderly patients with dementia
have shown a higher death rate associated with their use compared to
patients receiving a placebo (sugar pill).
The advisory applies to such antipsychotic drugs as
Abilify (aripiprazole), Zyprexa (olanzapine), Seroquel (quetiapine),
Risperdal (risperidone), Clozaril (clozapine) and Geodon (ziprasidone).
Symbyax, which is approved for treatment of depressive episodes
associated with bipolar disorder is also included in the agencys
advisory.
FDA is requesting that the manufacturers of all of
these kinds of drugs add a boxed warning to their drug labeling
describing this risk and noting that these drugs are not approved for
the treatment of behavioral symptoms in elderly patients with dementia.
Patients receiving these drugs for treatment of behavioral disorders
associated with dementia should have their treatment reviewed by their
health care providers.
In analyses of seventeen placebo-controlled studies of four drugs in
this class, the rate of death for those elderly patients with dementia
was about 1.6 to 1.7 times that of placebo. Although the causes of death
were varied, most seemed to be either heart-related (such as heart
failure or sudden death) or from infections (pneumonia).
The atypical antipsychotics fall into three drug
classes based on their chemical structure. Because the increase in
mortality was seen with atypical antipsychotic medications in all three
chemical classes, the agency has concluded that the effect is probably
related to the common pharmacologic effects of all atypical
antipsychotic medications, including those that have not been studied in
the dementia population.
The agency is considering adding a warning to the
labeling of older antipsychotic medications because limited data also
suggest a similar increase in mortality for these drugs. The review of
the data on these older drugs, however, is still on-going.
Additional information concerning todays
announcement is available on FDAs Web site at
http://www.fda.gov/cder/drug/infopage/antipsychotics/default.htm and
http://www.fda.gov/cder/drug/advisory/antipsychotics.htm.
FDA Public Health Advisory
Deaths with Antipsychotics in Elderly Patients
with Behavioral Disturbances
The Food and Drug Administration has determined
that the treatment of behavioral disorders in elderly patients with
dementia with atypical (second generation) antipsychotic medications is
associated with increased mortality. Of a total of seventeen placebo
controlled trials performed with olanzapine (Zyprexa), aripiprazole (Abilify),
risperidone (Risperdal), or quetiapine (Seroquel) in elderly demented
patients with behavioral disorders, fifteen showed numerical increases
in mortality in the drug-treated group compared to the placebo-treated
patients. These studies enrolled a total of 5106 patients, and several
analyses have demonstrated an approximately 1.6-1.7 fold increase in
mortality in these studies. Examination of the specific causes of these
deaths revealed that most were either due to heart related events (e.g.,
heart failure, sudden death) or infections (mostly pneumonia).
The atypical antipsychotics fall into three drug classes based on their
chemical structure. Because the increase in mortality was seen with
atypical antipsychotic medications in all three chemical classes, the
Agency has concluded that the effect is probably related to the common
pharmacologic effects of all atypical antipsychotic medications,
including those that have not been systematically studied in the
dementia population. In addition to the drugs that were studied, the
atypical antipsychotic medications include clozapine (Clozaril) and
ziprasidone (Geodon). All of tvhe atypical antipsychotics are approved
for the treatment of schizophrenia. None, however, is approved for the
treatment of behavioral disorders in patients with dementia. Because of
these findings, the Agency will ask the manufacturers of these drugs to
include a Boxed Warning in their labeling describing this risk and
noting that these drugs are not approved for this indication. Symbyax, a
combination product containing olanzapine and fluoxetine, approved for
the treatment of depressive episodes associated with bipolar disorder,
will also be included in the request.
The Agency is also considering adding a similar warning to the labeling
for older antipsychotic medications because the limited data available
suggest a similar increase in mortality for these drugs.
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