The U.S. Food and Drug Administration says it is ordering manufacturers of conventional antipsychotic drugs to include boxed warnings on the products.
The FDA said it 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.
In 2005, the FDA announced similar labeling changes for atypical or newer antipsychotic drugs. The warning will now cover older types of conventional antipsychotics.
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.
The drugs are FDA-approved primarily for the treatment of symptoms associated with schizophrenia. The decision to use antipsychotic medications in the treatment of patients with symptoms of dementia is left to the discretion of the physician. Such use is called off-label use and falls within the practice of medicine.
The new action includes such drugs as Compazine, Haldol, Loxitane, Mellaril, Moban, Prolixin, Thorazine and Trilafon.