These medications reduce the psychotic symptoms of schizophrenia and usually allow the patient to function more effectively and appropriately. However, doctors frequently prescribe them to treat elderly patients with dementia.
But from now on, the antipsychotics, which include drugs such as thorazine and prolixin, will carry a new black box warning alerting physicians of the danger, FDA officials announced Monday.
The new rules will require pharmaceutical companies to make safety-related changes to prescribing information and labeling to warn about an increased risk of death associated with the off-label use of the drugs when used to treat behavioral problems in older people with dementia, the federal agency said on its Website.
In 2005, the FDA announced similar labeling changes for atypical or newer antipsychotic drugswhich include newer drugs such as Zyprexa and Risperdal. The labeling warned of a higher risk for heart attack and pneumonia for elderly patients with dementia who received atypical antipsychotics.
The new warning will now cover older types of conventional antipsychotics, which include drugs such as Compazine, Haldol, Loxitane, Mellaril, Moban, Prolixin, Thorazine and Trilafon.
The warning for both classes of drugs will say clinical studies indicate antipsychotic drugs of both types are associated with an increased risk of death when used in elderly patients being treated for dementia-related psychosis.
