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Published: June 17, 2008
WASHINGTON - 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 aytpical antipsychotics.
The medicines include blockbusters such as 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 The drugs were developed in the 1950s and have largely been replaced by the newer medications, which are thought to have fewer side effects, such as tremors.
Under FDA orders, both drug types will carry boxed warning, the most serious a drug can carry, describing risks to dementia patients.
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 antipsychotic drugs have not been diagnosed with psychiatric problems, according to data released by Medicare earlier this year.
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