The Food and Drug Administration (FDA) has mandated that all older antipsychotic drugs being used to treat dementia-related psychosis in the elderly carry a black box warning because these medications increase the risk of death.
Some of these older anti-psychotics include Haldol, Moban, and Navane. Additionally, in 2005, the FDA mandated all newer antipsychotic drugs to carry black box warnings for the same reasons.
The FDA asserted in a statement that both classes of antipsychotic drugs will carry a warning, stating antipsychotics have been shown to increase the risk of death in elderly patients being treated for dementia-related psychosis in clinical trials.
Although the FDA has not approved the use of antipsychotic medication for the treatment of dementia, doctors are allowed to prescribe the drugs as they feel is appropriate, according to U.S. law.