SUNDAY August 24, 2008 (foodconsumer.org) -- Elderly
people using conventional or first generation antipsychotic medications are at
a higher risk of death from cardiovascular or respiratory disease than those
using an atypical or second generation antipsychotic medication, according to a
new study.
Early studies have already showed that second generation
medications may pose increased risk of death, but the new study showed the
first generation may not be safer than atypical antipsychotics for the elderly.
The study titled "Potential Causes of Higher Mortality
in Elderly Users of Conventional and Atypical Antipsychotic Medications"
was published online on August 4, 2008 in the Journal of the American
Geriatrics Society.
Antipsychotic medications are commonly used to treat
mental health symptoms and related conditions in the elderly, particularly
those who are enrolled in Medicare and live in nursing homes.
The FDA issued a public health advisory in 2005 after
studies found that second generation antipsychotic medications increase the
risk of death by 60 percent in elderly patients with dementia. But the warning
was not against the first general antipsychotics at that time.
Setoguchi S and colleagues from Brigham and Women's
Hospital and Harvard Medical School found the association between use of first
generation antipsychotics and increased death risk from cardiovascular disease
after they examined records of all elderly in British Columbia who took either
first or second generation antipsychotic medications from 1996 through 2004.
The study involved 12,882 patients who took conventional antipsychotics
and 24,359 patients who used atypical antipsychotics.
During the first 180 days of the treatment,
3,821 patients died with 49 percent from cardiovascular disease.
Patients on conventional antipsychotics were 23 percent
more likely to die from cardiovascular disease than those on atypical
antipsychotics.
The out-of-hospital
cardiovascular death risk was 36 percent higher among those taking first
generation than those taking the second generation antipsychotics.
The researchers also found those on the first generation
antipsychotics had a higher risk of death due to respiratory diseases, nervous
system diseases, and other causes.
On June 16, 2008, the FDA issued a warning against both
the first and generation antipsychotics saying that use of both types increases
risk of death in elderly patients treated for dementia-related psychosis. And the
agency also said that "Antipsychotics are not indicated for the treatment
of dementia-related psychosis."
A Boxed Warning was required for atypical antipsychotics
in 2005. In its statement issued on June 16, 2008, the FDA said from now on the
Boxed Warning will be also added to conventional antipsychotics.
The following is cited from the FDA
statement.
Antipsychotic drugs
commonly are categorized into two classes, the older "conventional"
antipsychotics and the newer "atypical" antipsychotics. Both classes
of drugs are dopamine receptor antagonists that work by blocking the action of
naturally occurring dopamine in the brain. They differ primarily in their side
effects, with the atypical drugs having a lower incidence of neurological side
effects such as involuntary movements or "tics."
Neither class of
antipsychotic is FDA-approved for use in the treatment of dementia-related
symptoms, which can include forgetfulness, poor memory, and an inability to
recognize familiar objects, sounds, or people. The drugs are FDA-approved
primarily for the treatment of symptoms associated with schizophrenia. The
decision to use antipsychotic medications in the treatment of patients with
symptoms of dementia is left to the discretion of the physician. Such use is
often called "off-label" use and falls within the practice of
medicine.
Recently, two
observational epidemiological studies were published that examined the risk of
death in elderly patients with dementia who were treated with conventional
antipsychotic drugs. The investigators compared the risk for death with use of
an atypical antipsychotic versus either no antipsychotic or the use of a
conventional antipsychotic. These studies have limitations that preclude
reaching a definitive conclusion about comparative death rates for atypical and
conventional antipsychotic drugs. Nevertheless, the FDA has concluded that
these studies, along with the earlier evidence for atypical antipsychotic
drugs, suggest that both classes of drugs should be considered to have an
increased risk of death when used in elderly patients treated for
dementia-related psychosis.
Antipsychotics that are required to carry a Boxed warning
include the following:
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