The US Food and Drug Administration has issued an alert requiring the manufacturers of conventional antipsychotic drugs to add a boxed warning to the drugs’ label which provides information about the risk of mortality in elderly patients treated for dementia-related psychosis.

The FDA said that the decision to update the prescribing information for conventional antipsychotics was based on findings from two recently published observational studies examining risk of death in patients who were treated with those drugs. The regulator noted that while it could not determine whether conventional drugs pose a higher risk of death than atypical antipsychotics, the overall weight of evidence “indicates that the conventional antipsychotics share the increased risk of death in elderly patients with dementia-related psychosis that has been observed for the atypical antipsychotics."

The FDA lists 11 treatments that need to have their labels updated, including Pfizer's Navane (thithixene), Johnson & Johnson's Haldol (haloperidol) and Endo’s Moban (molindrone). The labelling for atypical antipsychotics was updated to warn about the higher risk of mortality for elderly patients treated for dementia-related psychosis in 2005.

The agency concluded by stressing that no antipsychotics are indicated in the USA to treat patients with dementia-related psychosis.