The U.S. Food and Drug Administration has exercised its new authority under the Food and Drug Administration Amendments Act of 2007 (FDAAA) to require manufacturers of "conventional" antipsychotic drugs to make safety-related changes.

The Changes are required in prescribing information, or labeling, to warn about an increased risk of death associated with the off-label use of these drugs to treat behavioral problems in older people with dementia. In 2005, the FDA announced similar labeling changes for "atypical" antipsychotic drugs. At that time, Boxed Warnings, the FDA's strongest, were added.

The Boxed Warning will now be added to an older class of drugs known as "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.

The US has issued letters to the manufacturers of both types of antipsychotic drugs, under the new authority of FDAAA, notifying the manufacturers that they should make changes to drug labeling. Manufacturers of both classes of drugs are being asked to change labeling so that all of the drugs carry uniform warning language. Manufacturers of these drugs are required to submit new language to the FDA within 30 days, or to provide a reason why they do not believe such labeling changes are necessary. If they do not submit new language, FDAAA provides strict timelines for resolving the issue and allows the agency to initiate an enforcement action if necessary.

The medications involved in this action are:

Conventional Antipsychotic Drugs - Compazine (prochlorperazine), Haldol (haloperidol), Loxitane (loxapine) , Mellaril (thioridazine), Moban (molindrone),
Navane (thithixene), Orap (pimozide), Prolixin (fluphenazine), Stelazine (trifluoperazine), Thorazine (chlorpromazine) and Trilafon (perphenazine)

Atypical Antipsychotics - Abilify (aripiprazole), Clozaril (clozapine), FazaClo (clozapine), Geodon (ziprasidone), Invega (paliperidone), Risperdal (risperidone), Seroquel (quetiapine), Zyprexa (olanzapine) and Symbyax (olanzapine and fluoxetine)

(People taking antipsychotic drugs should not abruptly stop taking them. Caregivers and patients should talk to the patient's health care professionals about any concerns.)