 |
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.
 Back
to Top 
Back to
Antipsychotics
Date created: April 11, 2005 |
|
