The agency is requiring manufacturers of “conventional” antipsychotic drugs to change the labeling to warn about an increased risk of death associated with the off-label use to treat behavioral problems in older people with dementia.
In 2005, the FDA announced similar labeling changes for “atypical” antipsychotic drugs. At that time, Black Box warnings were added, and will now be added to the older “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, according to an FDA statement.
Both classes of drugs are dopamine receptor antagonists work by blocking the action of naturally occurring dopamine in the brain, the FDA notes. The key difference is effects - the atypical drugs having a lower incidence of neurological side effects such as involuntary movements or “tics.”
Neither class of antipsychotics is FDA-approved for use in the treatment of dementia-related symptoms, the FDA notes, but are FDA-approved primarily for the treatment of symptoms associated with schizophrenia.
Recently, 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 FDA acknowledges limitations that preclude reaching a definitive conclusion about comparative death rates for both classes. Still, the FDA has concluded these studies, along with the earlier evidence for atypicals, 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. The meds involved include Compazine; Haldol; Loxitane; Mellaril, Moban; Navane; Orap; Prolixin; Stelazine, Thorazine, Trilafon; Abilify; Clozaril; FazaClo; Geodon; Invega; Risperdal; Seroquel; Zyprexa and Symbyax.