FDA Issues Anti-Psychotic Drug Warning
U.S. health
officials advised physicians not to give elderly patients with dementia
anti-psychotic drugs approved for other medical conditions.
The Food and
Drug Administration said the drugs included in the warning were Abilify
(aripiparozole), Zyprexa (olanzapine), Seroquel (quetiapine), Risperdal
(risperidone), Clozaril (clozapine) and Geodon (ziprasidone).
All are approved
for treatment of schizophrenia and mania but are associated with a higher
death rate when given to elderly patients with dementia for behavioral
problems.
Symbyax, approved
for depression linked to biopolar disorder, also was included in the advisory.
Manufacturers
of these drugs must add a boxed warning to their labels, FDA said, describing
the risk and noting the drugs are not approved for treatment of behavioral
symptoms in elderly patients with dementia.
An analysis
of 17 placebo-controlled studies of four drugs in this class found the
death rate for elderly patients with dementia was about 1.6 to 1.7 times
that of placebo. Causes of death were varied but most seemed to be either
heart-related or stem from infections.
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