FDA Drug Safety Communication

FDA is notifying healthcare professionals that both conventional and atypical antipsychotics are associated with an increased risk of mortality in elderly patients treated for dementia-related psychosis.

In April 2005, FDA notified healthcare professionals that patients with dementia-related psychosis treated with atypical antipsychotic drugs are at an increased risk of death. Since issuing that notification, FDA has reviewed additional information that indicates the risk is also associated with conventional antipsychotics.

Antipsychotics are not indicated for the treatment of dementia-related psychosis.

This information reflects FDA's current analysis of data available to FDA concerning these drugs. FDA intends to update this communication when additional information or analyses become available.

Conventional antipsychotic drugs include:

Compazine (prochlorperazine)

Haldol (haloperidol)

Loxitane (loxapine)

Mellaril (thioridazine)

Moban (molindone)

Navane (thiothixene)

Orap (pimozide)

Prolixin (fluphenazine)

Stelazine (trifluoperazine)

Thorazine (chlorpromazine)

Trilafon (perphenazine)

View the full FDA Drug Safety Communication on FDA.gov