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Conventional Antipsychotics Get New Black Box Warning

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Older antipsychotic drugs – known as “conventional” antipsychotics – pose an increased risk of death when used to treat dementia in elderly patients, prompting the Food & Drug Administration (FDA) to ask the makers of these drugs to add a black box warning to their labels. In 2005, newer antipsychotic drugs, including Abilify and Risperdal, received a similar warning. The conventional antipsychotics subject to the new black box warning include:

Compazine (prochlorperazine)
Haldol (haloperidol)
Loxitane (loxapine)
Mellaril (thioridazine)
Moban (molindrone)
Navane (thithixene)
Orap (pimozide)
Prolixin (fluphenazine)
Stelazine (trifluoperazine)
Thorazine (chlorpromazine)
Tilafon (perphenazine)

    The FDA decided that the new black box warning was needed after 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. The agency 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.

    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.”

    Conventional and atypical antipsychotic drugs were approved to treat the symptoms of schizophrenia. They are not 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. However, physicians are free to use approved drugs in any way they see fit – a practice known as off-label use.

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