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The U.S. Food and Drug Administration on Monday warned
physicians that prescribing certain types of antipsychotic drugs to seniors suffering
from dementia could expose them to an increased risk of death.
Dr. Thomas Laughren, director of the FDA’s Division of
Psychiatry Products at the Center for Drug Evaluation and Research said the announcement
was an update to a 2005 action, when the agency added warnings about increased
heart attacks and pneumonia to drugs called atypical antipsychotics, which
include Eli Lilly & Co.’s Zyprexa and Johnson & Johnson’s Risperdal,
Reuters reports.
On Monday, the FDA said 11 other older drugs known as
typical antipsychotics should carry the same warning. They include Pfizer Inc.’s
Navane, Johnson & Johnson’s Haldol and Endo Pharmaceutical Holding Inc.’s
Moban, as well as Loxitane, Mellaril, Orap, Prolixin, Stelazine and Trilafon, some
of which have been discontinued, according to the FDA’s online database.
Under the FDA’s order both atypical antipsychotics and
typical antipsychotics will now carry boxed warnings, the most serious a drug
can carry, saying their use “is associated with an increased risk of death when
used in elderly patients treated for dementia-related psychosis.”
The measure follows the results of two recently published
epidemiological studies, involving more than 64,000 patients age 65 and older,
which showed that mortality rates were great with both typical and atypical
antipsychotics, if not higher with atypicals. Overall, the studies found that roughly
4.5 percent of patients with dementia taking these drugs died after 10 week of
treatment, compared with 2.6 percent of patients receiving a placebo.
Antipsychotics are approved to treat schizophrenia and
bipolar disease and not dementia, but doctors can use their discretion in
prescribing them.
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