Antipsychotics Increase Risk of Death in Dementia Patients, FDA Warns

FDA ALERT [6/16/2008]:  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.

The Food and Drug Administration warned doctors Monday that prescribing a certain group of psychiatric drugs (the atypical kind) to seniors suffering from dementia can increase their risk of death.

In April 2005, [the] FDA informed healthcare professionals and the public about the increased risk of death in elderly patients receiving atypical antipsychotic drugs to treat dementia-related psychosis.  “The analyses of 17 placebo-controlled trials that enrolled 5377 elderly patients with dementia-related behavioral disorders revealed a risk of death in the drug-treated patients of between 1.6 to 1.7 times that seen in placebo-treated patients.”  Most of the deaths appeared to be either cardiovascular (e.g., heart failure, sudden death) or infectious (e.g. pneumonia) in nature.


Though the FDA opine that “the methodological limitations in these two studies preclude any conclusion  that conventional antipsychotics have a greater risk of death with use than atypical antipsychotics”, they nonetheless have determined “that the overall weight of evidence, including these studies, 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.”

Conventional Antipsychotic Drugs Atypical Antipsychotic Drugs
Compazine (prochlorperazine) Abilify (aripiprazole)
Haldol (haloperidol) Clozaril (clozapine)
Loxitane (loxapine) FazaClo (clozapine)
Mellaril (thioridazine) Geodon (ziprasidone)
Moban (molindone) Invega (paliperidone)
Navane (thiothixene) Risperdal (risperidone)
Orap (pimozide) Seroquel (quetiapine)
Prolixin (fluphenazine) Zyprexa (olanzapine)
Stelazine (trifluoperazine) Symbyax (olanzapine and fluoxetine)
Thorazine (chlorpromazine)
Trilafon (perphenazine)

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