[PHNUTR-L] FDA Issues Warning on Antipsychotic Drug Use by Elderly
Kathrynne Holden, MS, RD
fivestar at nutritionucanlivewith.com
Wed Apr 13 10:45:53 PDT 2005
Colleagues, the following is FYI and does not necessarily reflect my own
opinion. I have no further knowledge of the topic.
FDA Issues Warning on Drug Use by Elderly
April 12, 2005
WASHINGTON (AP) -- Elderly patients with dementia were significantly
more likely to die prematurely if taking certain anti-psychotic drugs,
the government said Monday in an advisory to health care workers and
The Food and Drug Administration is asking manufacturers of atypical
anti-psychotic drugs to add to their labeling a boxed warning noting the
risks and that the drugs were not approved to treat symptoms of dementia
in the elderly.
Elderly patients taking the drugs for dementia-related symptoms should
consult with their doctors, the FDA said.
The drugs were approved for treating schizophrenia and mania, and
include such brands as Abilify, Zyprexa, Seroquel, Risperdal, Clozaril
and Geodon. Symbyax, which is approved for the treatment of depression
associated with bipolar disorder, is also included in the advisory.
An analysis of 17 studies covering four drugs showed the rate of death
for the elderly patients taking them was about 1.6 to 1.7 times the rate
of death for placebo users. The causes of death varied, but most seemed
to be either heart-related or from infection.
The FDA doesn't have data to indicate how many elderly patients take
this class of drugs, but agency officials believe that such
prescriptions are common.
Carole Copeland, spokesman for Eli Lilly and Co., the maker of Zyprexa,
said the company contacted doctors last year to alert them to the higher
risk of mortality cited Monday by the FDA. She said the company also
changed the drug's label last year to reiterate those higher risks. The
company will review the FDA's advisory to determine if further changes
were needed, she said.
Bristol-Myers Squibb and Otsuka America Pharmaceutical, Inc., which
market Abilify, said the companies take the FDA's request seriously and
would respond within 30 days. The companies also said a warning was
added in February to the package insert accompanying Abilify, which
noted a risk of stroke and similar events associated with its use by
elderly patients with dementia.
Kathrynne Holden, MS, RD < fivestar at nutritionucanlivewith.com >
"Ask the Parkinson Dietitian" http://www.parkinson.org/
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"Parkinson's disease: Guidelines for Medical Nutrition Therapy"
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