Psych Observer - Exposing Bad Psychiatrists

The U.S. Food and Drug Administration today exercised its new authority under the Food and Drug Administration Amendments Act of 2007 (FDAAA) to require manufacturers of “conventional” antipsychotic drugs to make safety-related changes to prescribing information, or labeling, to warn about an increased risk of death associated with the off-label use of these drugs to treat behavioral problems in older people with dementia.

In 2005, the FDA announced similar labeling changes for “atypical” antipsychotic drugs. At that time, Boxed Warnings, the FDA’s strongest, were added. The Boxed Warning will now be added to an older class of drugs known as “conventional” antipsychotics. The warning for both classes of drugs will say that clinical studies indicate that antipsychotic drugs of both types are associated with an increased risk of death when used in elderly patients treated for dementia-related psychosis.

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A Canadian study has found that prescribing antipsychotic drugs for elderly people may be dangerous.

Antipsychotic therapy is widely used to manage behavioural problems such as aggression which is sometimes associated with dementia; they are often prescribed prior to admission to a nursing home.

They are commonly used to treat psychosis with conditions such as schizophrenia, bipolar disorder, mania and delusional disorder.

The researchers from the Institute for Clinical Evaluative Sciences (ICES) in Ontario say elderly patients who are given antipsychotic drugs are at an increased risk of having an event that is serious enough to lead to hospitalization or death within a month of starting the therapy.

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