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FDA: Some psychiatric drugs can boost seniors' death risk

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FDA: Some antipsychotics used to treat dementia in seniors can
increase death risk

Increased heart attacks and pneumonia could occur

Drugs will now carry boxed warnings describing their risks to dementia
patients

Study shows seniors taking antipsychotics more likely to die than
those not

WASHINGTON (AP) -- The Food and Drug Administration warned doctors
Monday that prescribing a certain group of psychiatric drugs to
seniors suffering from dementia can increase their risk of death.

Antipsychotic drugs are approved to treat schizophrenia and bipolar
disease, but doctors frequently prescribe them to treat elderly
patients with dementia.

FDA's announcement was an update to a 2005 action, when regulators
added warnings about increased heart attacks and pneumonia to drugs
called atypical antipsychotics. The medicines include blockbusters
like Eli Lilly & Co.'s Zyprexa and Johnson & Johnson's Risperdal.

FDA said Monday those same risks apply to 11 older drugs known as
typical antipsychotics, including Pfizer's Navane and Endo
Pharmaceutical's Moban. The drugs were developed in the 1950s and have
largely been replaced by the newer medications, which are believed to
have fewer side effects, such as tremors.

Under FDA's orders, both drug types will now carry boxed warnings --
the most serious a drug can carry -- describing their risks to
dementia patients.

Analysts did not expect the announcement to negatively impact drug
company earnings because the original antipsychotics are available as
low-cost generics.

Federal officials have repeatedly urged doctors not to medicate
seniors unnecessarily. Despite such warnings, health professionals
continue to prescribe psychiatric drugs "off-label," or for uses that
have not been approved by FDA. About 20 percent of seniors in nursing
homes who receive antipsychotics have not been diagnosed with
psychiatric problems, according to data released by Medicare earlier
this year.

While FDA regulates the approval and marketing of drugs, doctors are
free to use their judgment when prescribing drugs.

The agency based its decision on two studies of a combined 65,000
seniors which showed those taking antipsychotics were more likely to
die than those not on the drugs. Agency officials said it's not clear
why antipsychotics hasten death. Scientists also could not determine
from the data whether one group carries greater dangers than the
other.

"We've struggled with this decision but we ultimately decided the data
are strong enough to expand this label to drugs in both classes," said
Thomas Laughren, director of FDA's psychiatric drug division.

The agency stressed there is "no approved drug for the treatment of
dementia-related psychosis," and recommended doctors consider other
treatment options.

"A lot of the things can be done to help change one's environment so
elderly patients can be more oriented and engaged," said Dr. Eric
Hollander, a professor at the Mt. Sinai School of Medicine.

Many of the behavioral problems seen in seniors can be improved with
simple, daily routines that patients can follow, Hollander said.

Copyright 2008 The Associated Press. All rights reserved.This material
may not be published, broadcast, rewritten, or redistributed.

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